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No Increase in Adverse Events with Lateral Extra-articular Tenodesis Augmentation of Anterior Cruciate Ligament Reconstruction – Results from the Stability Randomized Trial

Open AccessPublished:January 13, 2023DOI:https://doi.org/10.1016/j.jisako.2022.12.001

      Abstract

      Objectives

      Results from the Stability Study suggest that adding a lateral extra-articular tenodesis (LET) to a hamstring tendon autograft reduces the rate of anterior cruciate ligament reconstruction (ACLR) failure in high-risk patients. The purpose of this study is to report adverse events over the two-year follow up period and compare groups (ACLR alone vs ACLR + LET).

      Methods

      Stability is a randomized clinical trial comparing hamstring tendon ACLR with and without LET. Patients aged 14-25 years with an ACL deficient knee were included. Patients were followed and adverse events documented (type, actions taken, resolution) with visits at 3, 6, 12 and 24 months postoperatively. Adverse events were categorized as none, minor medical, minor surgical, contralateral ACL rupture, or graft rupture. Patient reported outcome measures (PROMs) collected at each visit included the Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee Score (IKDC), and ACL Quality of Life Questionnaire (ACL-QOL).

      Results

      618 patients were randomized (mean age 18.9 years, 302 (49%) male). Forty-five patients (7%) suffered graft rupture; 34 (11%) in the ACLR group compared to 11 (4%) in the ACLR+LET group (RRR=0.67, 95%CI 0.36 to 0.83, p<0.001). There were no differences in effusion or infection rates between groups. The ACLR+LET group experienced an increased number of hardware removals (10 vs. 4). Overall, the rate of minor medical events (11%), minor surgical events (7%), and ipsilateral or contralateral ACL tears (10%) were low considering the high-risk patient profile. Increasing severity of adverse events were associated with lower PROMs at 24 months post-operative. Patients in the ACLR+LET group reported greater degree of pain at 3-months only. There were no clinically significant differences in range of motion between groups.

      Conclusions

      The addition of LET to hamstring tendon autograft ACLR in young patients at high risk of re-injury resulted in a statistically significant reduction in graft rupture. Whilst the addition of LET may increase rates of hardware irritation, there was no significant increase in overall rates of minor medical adverse events, minor surgical events, or overall re-operation rates. The concerns regarding complications associated with a LET did not materialize in this study.

      Author Contribution

      HM completed data analysis for this manuscript. All other authors on the mast head of the manuscript were members of the steering committee of the Stability Study. AG and DB were co-PIs, designing the study and leading the data collection, analysis and manuscript preparation. All other authors were the respective site principal investigators at individual sites. All other authors had a role in designing the study, recruiting patients, performing surgery and leading follow up. All authors contributed to the manuscript and signed off on final draft. Members of the ‘Stability Study Group’ were all involved in patient recruitment and follow up.

      Competing Interests

      The Stability Study was funded by a research award from the International Society for Arthroscopic Knee Surgery and Orthopaedic Sports Medicine (ISAKOS). A.M.J.G. has received royalties from Smith & Nephew and Graymont Inc and consulting fees from Smith & Nephew, Ossur, and Olympus. R.L. has received consulting fees from Smith & Nephew.
      R.G.M. has received speaker fees from Bioventus, Pendopharm, Smith & Nephew, and Sanofi. T.S. has received speaking fees from Conmed, Smith & Nephew, and Joint Operations and consulting fees from Conmed. P.C.M.V. has received speaking fees from Conmed and Smith & Nephew and consulting fees from Conmed. L.A.H. has received speaking fees and consulting fees from Conmed.

      Stability Study Group

      London Health Science Centre, Western University, Fowler Kennedy Sport Medicine Clinic, London, Ontario: Alan Getgood, Dianne Bryant, Robert Litchfield, Kevin Willits, Trevor Birmingham, Chris Hewison, Stacey Wanlin, Andrew Firth, Hana Marmura, Ryan Pinto, Ashley Martindale, Lindsey O’Neill, Morgan Jennings, Michal Daniluk.
      Fraser Orthopaedic Institute, New Westminster, British Columbia: Dory Boyer, Bob McCormack, Mauri Zomar, Karyn Moon, Raely Moon, Brenda Fan, Bindu Mohan.
      Banff Sport Medicine, Banff, Alberta: S. Mark Heard, Gregory M. Buchko, Laurie A. Hiemstra, Sarah Kerslake, Jeremy Tynedal.
      Pan Am Clinic, Winnipeg, Manitoba: Peter MacDonald, Greg Stranges, Sheila Mcrae, LeeAnne Gullett, Holly Brown, Alexandra Legary, Alison Longo, Mat Christian, Celeste Ferguson.
      University of Calgary, Sport Medicine Centre, Calgary, Alberta: Alex Rezansoff, Nick Mohtadi, Rhamona Barber, Denise Chan, Caitlin Campbell, Alexandra Garven, Karen Pulsifer, Michelle Mayer.
      McMaster University, Hamilton, Ontario: Devin Peterson, Nicole Simunovic, Andrew Duong, David Robinson, David Levy, Matt Skelly and Ajaykumar Shanmugaraj.
      Queens University, Kingston, Ontario: Davide Bardana, Fiona Howells, Murray Tough.
      University Hospitals Coventry Warwickshire NHS Trust, Coventry, United Kingdom: Tim Spalding, Pete Thompson, Andrew Metcalfe, Laura Asplin, Alisen Dube, Louise Clarkson, Jaclyn Brown, Alison Bolsover, Carolyn Bradshaw, Larissa Belgrove, Francis Millan, Sylvia Turner, Sarah Verdugo, Janet Lowe, Debra Dunne, Kerri McGowan, Charlie-Marie Suddens.
      Antwerp Orthopaedic Center, Ghent, Belgium: Peter Verdonk, Geert Declerq, Kristien Vuylsteke, Mieke Van Haver.

      What are the new findings?

      We found a clinically relevant reduction in anterior cruciate ligament graft rupture with the addition of a lateral extra-articular tenodesis in young patients at high risk of re-injury. The addition of a lateral extra-articular tenodesis did not increase the rate of serious adverse events and reduced the rates of new meniscal tears. The addition of a lateral extra-articular tenodesis did increase the incidence of hardware removal due to irritation at the lateral extra-articular tenodesis repair site.

      Introduction

      Recent research has demonstrated that anterior cruciate ligament reconstruction (ACLR) does not always result in optimal outcomes. Studies have identified a high rate of persistent rotatory laxity as demonstrated by a positive pivot shift,
      • Mohtadi N.
      • Chan D.
      • Barber R.
      • Oddone Paolucci E.
      A Randomized Clinical Trial Comparing Patellar Tendon, Hamstring Tendon, and Double-Bundle ACL Reconstructions: Patient-Reported and Clinical Outcomes at a Minimal 2-Year Follow-up.
      ,
      • Mohtadi N.G.
      • Chan D.S.
      • Dainty K.N.
      • Whelan D.B.
      Patellar tendon versus hamstring tendon autograft for anterior cruciate ligament rupture in adults.
      reduced levels of return to sport,
      • Ardern C.L.
      • Webster K.E.
      • Taylor N.F.
      • Feller J.A.
      Return to sport following anterior cruciate ligament reconstruction surgery: A systematic review and meta-analysis of the state of play.
      and high rates of failure. The latter has been demonstrated to be worse with younger age,
      • Webster K.E.
      • Feller J.A.
      Exploring the High Reinjury Rate in Younger Patients Undergoing Anterior Cruciate Ligament Reconstruction.
      ,
      • Webster K.E.
      • Feller J.A.
      • Leigh W.B.
      • Richmond A.K.
      Younger patients are at increased risk for graft rupture and contralateral injury after anterior cruciate ligament reconstruction.
      probably because age is a surrogate for activity level.
      • Kaeding C.C.
      • Pedroza A.D.
      • Reinke E.K.
      • et al.
      Risk factors and predictors of subsequent ACL injury in either knee after ACL reconstruction: Prospective analysis of 2488 primary ACL reconstructions from the MOON cohort.
      Significant focus has recently been placed on the anterolateral complex (ALC), particularly in regard to anterolateral ligament (ALL) reconstruction or lateral extra-articular tenodesis (LET), as a means to provide greater rotational stability following ACLR, with the hope of reducing the failure rate.
      • Getgood A.
      • Brown C.
      • Lording T.
      • et al.
      The anterolateral complex of the knee: results from the International ALC Consensus Group Meeting.
      The LET has been utilized in knee surgery to address ACL deficiency for many decades. While a number of studies showed improved stability rates when combined with ACLR,
      • Hewison C.E.
      • Tran M.N.
      • Kaniki N.
      • Remtulla A.
      • Bryant D.
      • Getgood A.M.
      Lateral Extra-articular Tenodesis Reduces Rotational Laxity When Combined With Anterior Cruciate Ligament Reconstruction: A Systematic Review of the Literature.
      it fell out of favor following an American Orthopaedic Society for Sports Medicine (AOSSM) consensus meeting that determined that the perceived high rates of complications observed did not make the procedure worth performing.

      Pearle A, Bergfeld J. Extraarticular reconstruction in ACL deficient knee. American Orthopaedic Society for Sports Medicine. Published online 1992.

      The main concerns cited were lateral compartment over constraint, osteoarthritis, and irritation from disturbing the iliotibial band.
      With the goal of reducing ACLR failure, we completed a multicenter randomized clinical trial (Stability Study) to evaluate single bundle, hamstring autograft ACLR with LET in young patients deemed to be at high risk of graft failure.
      • Getgood A.M.J.
      • Bryant D.M.
      • Litchfield R.
      • et al.
      Lateral Extra-articular Tenodesis Reduces Failure of Hamstring Tendon Autograft Anterior Cruciate Ligament Reconstruction: 2-Year Outcomes From the STABILITY Study Randomized Clinical Trial.
      The addition of a LET to the hamstring autograft ACLR resulted in a clinically important and statistically significant reduction in the primary outcome of clinical failure (composite of persistent rotatory laxity and graft rupture) (40% vs. 25%; relative risk reduction (RRR), 0.38; 95% CI, 0.21-0.52; P < .0001).
      • Getgood A.M.J.
      • Bryant D.M.
      • Litchfield R.
      • et al.
      Lateral Extra-articular Tenodesis Reduces Failure of Hamstring Tendon Autograft Anterior Cruciate Ligament Reconstruction: 2-Year Outcomes From the STABILITY Study Randomized Clinical Trial.
      Due to the historical concern of associated morbidity with the addition of LET, the purpose of this paper is to report the adverse event profile within the Stability study and compare the rates of adverse events between those who had ACLR with and without LET. Our hypothesis was that with modern surgical and rehabilitation techniques there would be no increase in complication rates with the addition of the LET.

      Methods

      Study Design and Participants

      This study was a pragmatic, parallel groups, multicenter randomized clinical trial in which young patients with ACL deficiency were randomly allocated to either ACLR or ACLR with LET (ACLR+LET). Seven study centers in Canada and two centers in Europe actively recruited patients. The study was approved by Western University’s Research Ethics Board and local Research Ethics Boards at each institution and was registered on Clinical Trials.gov (NCT02018354). A full study protocol and primary outcome results have been previously published.
      • Getgood A.
      • Bryant D.
      • Firth A.
      • et al.
      The Stability study: A protocol for a multicenter randomized clinical trial comparing anterior cruciate ligament reconstruction with and without Lateral Extra-articular Tenodesis in individuals who are at high risk of graft failure.
      ,
      • Getgood A.M.J.
      • Bryant D.M.
      • Litchfield R.
      • et al.
      Lateral Extra-articular Tenodesis Reduces Failure of Hamstring Tendon Autograft Anterior Cruciate Ligament Reconstruction: 2-Year Outcomes From the STABILITY Study Randomized Clinical Trial.
      Briefly, patients were approached for participation if they were between 14-25 years old, had an ACL deficient knee, and were at a higher risk of re-injury, defined as the presence of two or more of the following: 1) participating in competitive pivoting sport;
      • Borchers J.R.
      • Pedroza A.
      • Kaeding C.
      Activity level and graft type as risk factors for anterior cruciate ligament graft failure: A case-control study.
      2) presence of a grade 2 pivot shift or greater; 3) generalized ligament laxity (Beighton score of 4 or greater) or genu recurvatum greater than 10 degrees.
      • Cooper D.E.
      • Dunn W.R.
      • Huston L.J.
      • et al.
      Physiologic Preoperative Knee Hyperextension Is a Predictor of Failure in an Anterior Cruciate Ligament Revision Cohort: A Report From the MARS Group.
      Patients were ineligible if any of the following were present, 1) previous ACL reconstruction on either knee; 2) multi-ligament injury (two or more ligaments requiring surgical attention); 3) a symptomatic articular cartilage defect requiring treatment other than debridement; 4) greater than 3 degrees of asymmetric varus; and 5) unable or unwilling to be followed up for 2 years postoperative.
      Upon determining eligibility, and willingness to participate, patients were randomized via phone or web-based software program (Empower Inc.) in a 1:1 ratio to either ACLR alone or ACLR with LET, stratified by surgeon, sex and meniscus repair. All patients underwent an anatomic single bundle hamstring autograft ACLR performed in a standardized fashion across sites. Patients who were randomized to receive LET had this performed using a standardized modified Lemaire technique, as previously published.
      • Jesani S.
      • Getgood A.
      Modified Lemaire Lateral Extra-Articular Tenodesis Augmentation of Anterior Cruciate Ligament Reconstruction.
      All patients, regardless of group allocation, received preoperative and postoperative verbal and written standardized instructions for rehabilitation, focused on early range of motion and weight bearing as tolerated, unless a meniscus repair dictated otherwise. The patient’s physical therapist also received a copy of the standardized protocol. A brace was not routinely used.

      Adverse Events and Patient Reported Outcomes

      Subjects were evaluated at 2 and 6 weeks, and 3, 6, 12 and 24 months following surgery. An adhesive tape was applied to the lateral side of the knee concealing presence or absence of LET scar, to ensure that outcome assessors were blind to group allocation.
      Any adverse event that occurred during the study period was recorded prospectively. For each adverse event, the following were reported: identification (general, anesthesia related, wound related, neurovascular, knee specific, procedure related), actions taken (medications, surgery, etc.) and whether the event had resolved. Graft rupture was defined as a tear of the graft confirmed by either MRI or arthroscopic examination (performed in response to suspicion of a graft rupture).
      Range of motion was assessed by measuring passive knee extension and active-assisted knee flexion using a standardized approach with a goniometer. Pain was recorded using the P4 questionnaire, which consists of 4 items that address pain intensity in the morning, afternoon, evening, and with activity over the past 2 days.
      • Roos E.M.
      • Roos H.P.
      • Lohmander L.S.
      • Ekdahl C.
      • Beynnon B.D.
      Knee Injury and Osteoarthritis Outcome Score (KOOS) - Development of a self-administered outcome measure.
      ,
      • Sonnery-Cottet B.
      • Archbold P.
      • Zayni R.
      • et al.
      Prevalence of Septic Arthritis After Anterior Cruciate Ligament Reconstruction Among Professional Athletes.
      Each item is scored on a 0-to-10 numeric pain rating scale; therefore the total P4 score can vary from 0 (no pain) to 40 (the highest possible pain level).
      Patient reported outcome measures (PROMs) included the ACL Quality of Life Questionnaire (ACL-QOL)
      • Mohtadi N.
      Development and validation of the quality of life outcome measure (questionnaire) for chronic anterior cruciate ligament deficiency.
      , International Knee Documentation Committee Subjective Knee Form (IKDC)
      • Irrgang J.J.
      • Anderson A.F.
      • Boland A.L.
      • et al.
      Development and validation of the International Knee Documentation Committee Subjective Knee Form.
      and the Knee Injury and Osteoarthritis Outcome Score (KOOS)
      • Roos E.M.
      • Roos H.P.
      • Lohmander L.S.
      • Ekdahl C.
      • Beynnon B.D.
      Knee Injury and Osteoarthritis Outcome Score (KOOS) - Development of a self-administered outcome measure.
      . All three scores range from 0 (worst) to 100 (best).

      Sample size calculation

      The primary outcome of the Stability Study was graft failure, as defined by either a graft rupture or symptomatic instability requiring revision ACLR surgery, or persistent rotational laxity as measured by an asymmetrical positive pivot shift (grade 2 pivot shiftor higher at any post-operative visit, or grade 1 pivot shift at consecutive post-operative visits) compared to the contralateral side. Based on this primary outcome, we estimated that within this group of high-risk patients, the absolute risk (AR) of graft failure (as defined above) following ACLR ranges from 25-35%.
      • Lind M.
      • Menhert F.
      • Pedersen A.B.
      Incidence and outcome after revision anterior cruciate ligament reconstruction: Results from the Danish registry for knee ligament reconstructions.
      ,
      • Magnussen R.A.
      • Lawrence J.T.R.
      • West R.L.
      • Toth A.P.
      • Taylor D.C.
      • Garrett W.E.
      Graft size and patient age are predictors of early revision after anterior cruciate ligament reconstruction with hamstring autograft.
      ,
      • Mohtadi N.
      • Chan D.
      • Barber R.
      • Oddone Paolucci E.
      A Randomized Clinical Trial Comparing Patellar Tendon, Hamstring Tendon, and Double-Bundle ACL Reconstructions: Patient-Reported and Clinical Outcomes at a Minimal 2-Year Follow-up.
      ,
      • Webster K.E.
      • Feller J.A.
      Exploring the High Reinjury Rate in Younger Patients Undergoing Anterior Cruciate Ligament Reconstruction.
      We agreed that a relative risk reduction (RRR) in graft failure rate of at least 40% would merit a change in practice (i.e. is of sufficient magnitude to warrant the additional costs related to the LET procedure). Thus, with 255 patients per group and a type 1 error rate of 5% there would be approximately 80% power to detect a relative risk reduction (RRR) in rate of re-rupture in the ACLR+LET group of 40% or greater. A combined withdrawal and lost-to-follow-up rate of approximately 15% was anticipated, requiring a total recruitment of 600 patients (300 per group).

      Statistical Analysis

      All patients were analyzed in the group to which they were randomized (i.e., intention to treat principle). For graft rupture in each group, the absolute risk, relative risk (RR) and risk difference (RD) of graft rupture with 95% confidence intervals around each estimate, were calculated using a Mantel Haentzel Test (random effect of surgeon) to determine the significance of the association between the addition of LET and graft failure rates.
      We report descriptive information (number and proportion of patients) for the specific adverse events (general, related to ACLR, related to LET). To statistically compare the adverse event profile between groups (ACLR alone versus ACLR+LET), we categorized the level of adverse event patients experienced into four groups: none (no adverse event), minor medical (event such as a superficial infection, pain, or muscle strain that either resolved spontaneously or with minimum medical management), minor surgical (adverse event such as meniscus tear or stiffness that required surgical intervention but is not a graft rupture), contralateral ACL rupture, and graft rupture. Each patient was only included once, so patients with more than one adverse event were included in the category of their most severe adverse event. We reported the proportion of patients with each adverse event type and conducted a Pearson Chi-Square test to make statistical comparisons between groups.
      For the P4, the mean and standard error for each group at each time point was calculated with the mean between-group difference with 95% confidence interval at 1 and 2 years postoperative. An analysis of covariance was also completed where the preoperative (baseline score) was used as a covariate.
      To investigate the association of adverse events to P scores, we used a generalized linear model comparing mean PROM scores reported for patients with the different levels of adverse events (none, minor medical, minor surgical, graft/ACL tear). We performed multiple imputation using chained equations (MICE) using potential predictors of missingness and outcome (age, sex, BMI, group, adverse event category, baseline PROM scores, and 12-month PROM scores) to impute 24-month outcome scores for those missing PROMs. We performed five iterations, conducted diagnostic evaluations for each iteration, then used the pooled data sets in our analysis. We used a generalized linear model adjusted for baseline questionnaire scores, to determine the effect of adverse event type on 24-month outcome scores. We present pooled adjusted mean scores and standard errors for each adverse event group and report p-values representing the significance of the difference in means between each adverse event group and the group with no adverse events. We performed a sensitivity analysis where we removed patients that had an adverse event at the 24-month timepoint to determine whether the effects of these events were due to the recency of the event rather than the severity itself. Adverse events reported after 24-month PROMs had been completed (n=4) were not included in this analysis but were included in the descriptive data. All analyses were performed in SPSS (IBM version 28) and statistical significance was set at p<0.05.

      Results

      Subject characteristics

      Enrolment of subjects took place between January 2014 and March 2017. Of the 1033 subjects screened for eligibility (Figure 1), 358 were ineligible and 48 declined participation. Thus 618 patients were randomized; 589 completed the study, 18 patients were lost to follow-up, and 11 patients were withdrawn (5% attrition rate). There were no statistical differences between groups for any patient characteristics at baseline (see Table 1).
      Figure 1
      Figure 1CONSORT (Consolidated Standards of Reporting Trials) flow diagram for the Stability Study. ACL, anterior cruciate ligament; ACLR, anterior cruciate ligament reconstruction; AE, adverse event; BPTB, bone-patellar tendon-bone; HTO, high tibial osteotomy; LET, lateral extra-articular tenodesis; MICE, multivariate imputation by chained equations; OA, osteoarthritis; PROM, patient-reported outcome measure.
      Table 1Patient Demographics.
      CharacteristicACLR aloneACLR + LETP value
      Sex, n males (%)151 (48)151 (49)0.44
      Age, years (mean ± SD)18.8 ± 3.219.1 ± 3.30.33
      Height, inches (mean ± SD)68.1 ± 3.767.8 ± 3.60.29
      Weight, kg (mean ± SD)71.8 ± 14.871.3 ± 14.30.75
      BMI, kg/m2 (mean ± SD)23.8 ± 3.724.0 ± 3.80.68
      Beighton score, 0–9 (mean ± SD)3.1 ± 2.73.0 ± 2.80.58
      Eligibility Criteria
       +GLL, +pivot, +sport125 (40)124 (41)0.37
       +GLL, +pivot, -sport11 (4)9 (3)
       +GLL, -pivot, +sport28 (9)17 (6)
       -GLL, +pivot, +sport144 (47)153 (50)
      Time from injury to surgery, months (mean ± SD)8.1 ± 18.99.3 ± 16.70.41
      Operative limb, n dominant (%)161 (52)156 (52)0.98
      Mechanism of injury, n non-contact (%)176 (74)166 (72)0.32
      Sport played at time of injury, n (%)
      Soccer100 (32)122 (39)0.06
      Basketball54 (18)36 (12)
      Football or Rugby54 (18)56 (19)
      Downhill skiing16 (5)13 (4)
      Volleyball19 (6)12 (4)
      Other66 (21)66 (22)
      Sport played at time of RTS, n (%)
      Soccer72 (23)81 (26)0.38
      Basketball37 (12)27 (9)
      Football or Rugby27 (9)30 (10)
      Downhill skiing13 (4)10 (3)
      Volleyball16 (5)15 (5)
      Other99 (32)87 (28)
      Did not return to sport47 (15)56 (18)
      Smoking status, n (%)0.49
      Current smoker17 (5)16 (5)
      Ex-smoker11 (4)6 (2)
      Non-smoker279 (91)279 (93)
      Graft source, n (%)
      Semitendinosus and gracilis tendons301 (96)297 (96)0.57
       3 strand2 (<1)2 (<1)
       4 strand140 (45)135 (44)
       5 strand119 (38)119 (39)
       6 strand38 (12)39 (13)
      Semitendinosus tendon11 (4)11 (4)
       3 strand5 (2)3 (1)
       4 strand6 (2)8 (3)
      Graft diameter, mm (median, min, max)8 (6, 10)8 (6, 10)0.32
      Meniscectomy, n (%)
      Medial21 (7)18(6)0.22
      Lateral67 (22)54 (18)0.35
      Both11 (4)12 (4)0.38
      Meniscal repair, n (%)<0.05
      Medial75 (24)91 (20)
      Lateral36 (12)24 (8)
      Both19 (6)18 (6)
      Change in rehab due to meniscus repair, n (%)51 (16)50 (16)0.84
      Chondral defect, ICRS >3 any compartment, n (%)15 (5)14 (4)0.52
      Time (months) to RTS, median (IQR)11 (8-14)11 (8-17)0.01
      Exposure to sport (months), median (IQR)13 (4-16)13 (5-15)0.40
      Note: * under anesthetic.
      ACL alone: n = 312.
      ACL + LET: n = 306.
      ACLR, Anterior Cruciate Ligament Reconstruction; LET, Lateral extra-articular tenodesis; BMI, Body mass index; GLL, generalized ligamentous laxity; RTS, Return to sport; ICRS, International Cartilage Repair Society.

      Adverse Events

      The adverse event status was documented for all 618 randomized patients at surgery and follow-up visits until they completed the study at 24 months post-operative, were lost to follow-up, or withdrawn. Table 2 shows a detailed distribution of adverse events reported in the study up to two years post-operative. In total, 45 patients experienced graft rupture, 34 of 312 (11%) in the ACLR group compared with 11 of 306 (4%) in the ACL+LET group (RRR, 0.67; 95% CI, 0.36-0.83; P < .001). The RD was 8% (95% CI, 3%-12%).
      Table 2Adverse events by group.
      GeneralACLRACLR+LETOverall
      Persistent Effusion6 (2%)10 (3%)16 (3%)
       Aspiration3 (1%)1 (<1%)4 (<1%)
       Reoperation (arthrolysis, resect adhesions, cyclops)2 (<1%)1 (<1%)3 (<1%)
      Superficial Infection2 (<1%)4 (1%)6 (1%)
      Deep Infection2 (<1%)1 (<1%)3 (<1%)
      Periostitis01 (<1%)1 (<1%)
      Related to ACLRACLRACLR+LET
      Graft Rupture34 (11%)11 (4%)45 (8%)
      Contralateral ACL rupture12 (4%)7 (2%)19 (3%)
      Excessive Pain6 (2%)6 (2%)12 (2%)
       Patellofemoral (physio)01 (<1%)1 (<1%)
       Intra-articular injection2 (<1%)1 (<1%)3 (<1%)
       Reoperation (scar resection, cyclops)1 (<1%)1 (<1%)2 (<1%)
      Excessive stiffness (all MUA, scar resection, cyclops, arthrolysis)2 (<1%)5 (2%)7 (1%)
      ACL hardware removal4 (1%)1 (<1%)5 (<1%)
      Hamstring strain/tear6 (2%)2 (<1%)8 (1%)
      Retear meniscal tear (unrelated to graft rupture)7 (2%)13 (4%)20 (3%)
      Retear meniscal tear (associated with a graft rupture)01 (<1%)1 (<1%)
      New meniscal tear (unrelated to graft rupture)6 (2%)3 (<1%)9 (2%)
      New meniscal tear (associated with a graft rupture)2 (<1%)1 (<1%)3 (<1%)
      Complex regional pain syndrome01 (<1%)1 (<1%)
      MCL (1 grade 1 sent for PT, 1 rupture reoperation to re-insert)02 (<1%)2 (<1%)
      Related to LETACLR+LETOverall
      Intraoperative
       LET graft difficulties at surgery6 (2%)6 (1%)
       Damage to FCL attachment (repaired)1 (<1%)1 (<1%)
      Postoperative
       Haematoma over LET site3 (<1%)3 (<1%)
       IT band snapping2 (<1%)2 (<1%)
       LET hardware removal10 (3%)10 (2%)
       Over-constrained lateral compartment1 (<1%)1 (<1%)
      ACLR, Anterior Cruciate Ligament Reconstruction; FCL, fibular collateral ligament, LET, Lateral extra-articular tenodesis; MUA, manipulation under anesthesia; PT, Physiotherapy.
      An over-constrained lateral compartment was defined subjectively based on reduced internal rotation as assessed by a surgeon and reduced motion as assessed by the patient.
      ACL alone: n = 312.
      ACL + LET: n = 306.
      There was no difference in the rates of persistent effusion, superficial or deep infection. The addition of the LET saw an increased number of procedure-related complications, with fewer patients complaining of hardware irritation in the ACLR than ACLR+LET group (4 vs. 14). Six LET graft difficulties were reported at the time of surgery. These included three cases of LET graft rupture, and three cases of LET staple hardware failure resolved with hardware exchange. Ten of the ACLR+LET patients required removal of the LET staple.
      There was no significant difference in the proportion of patients experiencing minor medical or minor surgical adverse events, or contralateral ACL tears between groups (Table 3). A significantly larger proportion of patients in the ACLR alone group experienced a graft rupture (11%) compared to the ACLR+LET group (4%, p<0.01). The overall rate of reoperation was not significantly different between the ACLR alone (18%) and ACLR+LET (15%) groups (p = 0.37).
      Table 3Adverse event category by group.
      Adverse Event CategoryACLRACLR+LETp-value
      Minor Medical Adverse Events29 (9%)40 (13%)0.14
      Minor Surgical Events (excluding ACL tears)18 (6%)28 (9%)0.11
      Contralateral ACL Rupture12 (4%)7 (2%)0.26
      Graft Rupture34 (11%)11 (4%)<0.01
      Overall Reoperation Rate56 (18%)46 (15%)0.32
      ACLR, Anterior Cruciate Ligament Reconstruction; LET, Lateral extra-articular tenodesis.
      ACL alone: n = 312.
      ACL + LET: n = 306.
      Adverse event data for the entire sample, including frequencies of each type are shown in Table 4. Overall, 70% of minor medical complications (48 of 69) and 63% of minor surgical complications (29 of 46) reported in the two-year study period occurred within the first 12-months postoperative, compared to 37% of contralateral ACL tears or 49% (7 of 19) of graft ruptures (22 of 45). About half of the overall reoperations occurred in each of the first and second year post-operative.
      Table 4Adverse events recorded within the first 12-months post-operative and the total number of adverse events recorded within the entire 24-month period.
      12-months post-operative24-months post-operative
      No Adverse Events512 (83%)439 (71%)
      Minor Medical Adverse Events48 (8%)69 (11%)
       ACLR18 (6%)29 (9%)
       ACLR + LET30 (10%)40 (13%)
      Minor Surgical Events (excluding ACL tears)29 (5%)46 (7%)
       ACLR11 (4%)18 (6%)
       ACL + LET18 (6%)28 (9%)
      Contralateral ACL Tear7 (1%)19 (3%)
       ACLR6 (2%)6 (2%)
       ACL + LET1 (<1%)6 (2%)
      Graft Rupture22 (4%)45 (7%)
       ACLR18 (6%)33 (11%)
       ACLR + LET4 (1%)12 (4%)
      Overall Reoperation Rate54 (9%)102 (16%)
       ACLR32 (10%)56 (18%)
       ACLR + LET22 (7%)46 (15%)

      Pain

      For both groups, pain was minimal by three months postoperative (approximately 8/40 on the P4). Overall pain was lower in the ACLR compared to the ACL+LET group (adjusted mean difference = -1.7 (95%CI -2.9 to -0.6), p=0.004) (Table 5). This difference was not observed beyond 3 months postoperative.
      Table 5Patient reported pain for each group over time.
      P4 Score (0-10)ACLR aloneACLR + LETAdjusted MD (95%CI)p-value
      3m6.8±0.48.6±0.4-1.7 (-2.9 to -0.6)0.004
      6m4.7±0.45.3±0.4-0.6 (-1.6 to 0.5)0.27
      12m3.4±0.33.4±0.30.0 (-0.9 to 0.9)1.0
      24m2.9±0.33.0±0.4-0.1 (-1.1 to 0.9)0.84
      ACLR, Anterior Cruciate Ligament Reconstruction; LET, Lateral extra-articular tenodesis; MD, mean between groups difference; m, months.
      ACL alone: n = 312.
      ACL + LET: n = 306.

      Range of motion

      No clinically significant differences in range of motion were observed between to the two treatment groups at 6, 12 or 24 months postoperative. At 3 months post-operative, the ACLR+LET group demonstrated a 2.1o (95%CI 0.6 to 3.6) reduction in flexion and a 0.7o (1.3 to 0.1) reduction in extension compared to ACLR alone (Table 6).
      Table 6Range of motion on the operative side, side-to-side difference, and adjusted mean difference between groups for side-to-side difference.


      ROM
      ACL aloneACL+LETAdjusted Mean Differencep-value
      OperativeSide-to-SideOperativeSide-to-SideSide-to-Side
      Passive Extension
      Baseline-1.9±0.41.5±0.2-2.8±0.31.3±0.20.2 (95% CI -0.4 to 0.8)0.43
      3 month-1.4±0.32.6±0.2-0.8±0.32.7±0.2-0.7 (95% CI -1.3 to -0.1)0.03
      6 month-2.9±0.31.3±0.2-2.7±0.31.6±0.2-0.3 (95% CI -0.8 to 0.2)0.28
      12 month-3.0±0.30.8±0.2-3.2±0.30.9±0.2-0.1 (95%CI -0.5 to 0.3)0.63
      24 month-3.1±0.30.6±0.1-3.2±0.30.8±0.1-0.2 (95%CI -0.6 to 0.2)0.27
      Active Assisted Flexion
      Baseline137.5±0.6-4.1±0.5138.9±0.6-3.1±0.5-0.9 (95%CI -2.2 to 0.4)0.16
      3 month135.0±0.7-5.3±0.5134.2±0.7-7.4±0.62.1 (95%CI 0.6 to 3.6)<0.01
      6 month138.9±0.5-3.3±0.4137.9±0.6-4.3±0.41.0 (95%CI -0.0 to 2.1)0.05
      12 month139.9±0.5-2.5±0.3139.7±0.5-2.2±0.3-0.3 (95%CI -1.2 to 0.7)0.58
      24 month140.6±0.6-2.5±0.3140.4±0.6-2.2±0.3-0.3 (95%CI -1.2 to 0.6)0.53
      ACLR, Anterior Cruciate Ligament Reconstruction; LET, Lateral extra-articular tenodesis.
      ACL alone: n = 312.
      ACL + LET: n = 306.
      Note: Negative values for the operative side indicate hyperextension. Positive values for side-to-side differences in extension indicate a loss of extension on the operative side. Negative values for side-to-side differences in flexion indicate a loss of flexion on the operative side.

      Patient reported outcome measures

      Complete questionnaire data was available for 534 patients (86.4%) at two-years post-operative, and we imputed scores for the remainder. Sixteen patients missing baseline data were excluded from the analysis. When all complications recorded up to 24 months post-operative were included, 24-month PROM scores for patients with any type of complication were significantly lower (p <0.05) than those with no complications across all outcomes except for the KOOS ADL subscale (Table 7). For each of the significant outcomes, there was a trend of lower pooled mean scores as complication severity increased. The sensitivity analysis, which removed patients with complications that occurred between 12 and 24 months (n = 73) showed that graft tears and contralateral ACL tears within the first 12-months post-operative led to significantly lower PROM scores at two-years post-operative (p<0.05), whilst the effect of smaller minor surgical complications did not always have the same impact (Table 8). Minor surgical complications within the first 12-months postoperative did lead to statistically significant differences in outcome score on the ACL-QOL and KOOS Pain subscale (p<0.05). In this analysis, the pooled mean scores for patients with minor complications were not significantly different than those with no complications for any outcome, and surgical complications only showed significant differences from the no complications group in ACL-QOL and KOOS Pain scores.
      Table 724-month PROM scores for patients with various levels of adverse events occurring up to 24 months post-operative (n = 602), represented as mean ± SE (p-value).
      NoneMinor MedicalMinor SurgicalGraft/ACL Tear
      ACL-QOL81.1 ± 1.0 (ref)71.9 ± 2.4 (<0.01)66.7 ± 3.4 (<0.01)55.4 ± 2.6 (<0.01)
      IKDC89.2 ± 0.7 (ref)83.5 ± 1.6 (<0.01)81.0 ± 2.1 (<0.01)71.1 ± 1.9 (<0.01)
      KOOS Pain93.0 ± 0.5 (ref)89.8 ± 1.2 (0.02)87.0 ± 1.6 (<0.01)84.7 ± 1.7 (<0.01)
      KOOS Symptoms86.2 ± 0.7 (ref)82.2 ± 1.6 (0.02)79.4 ± 2.3 (<0.01)75.0 ± 2.3 (<0.01)
      KOOS ADLs97.4 ± 0.3 (ref)95.2 ± 0.8 (0.01)95.7 ± 1.1 (0.13)92.1 ± 1.0 (<0.01)
      KOOS Sport87.3 ± 0.9 (ref)81.5 ± 2.1 (0.01)77.4 ± 2.8 (<0.01)67.2 ± 2.9 (<0.01)
      KOOS QOL78.1 ± 1.0 (ref)68.9 ± 2.5 (<0.01)66.1 ± 3.4 (<0.01)53.5 ± 3.3 (<0.01)
      P-values represent statistical significance in pooled mean scores between each complication group and the group with no complications (i.e., reference level).
      SE = standard error.
      Ref = reference level, no p-value available.
      Table 824-month PROM scores for patients with various levels of adverse events complications occurring within the first 12 months post-operative (n = 545), represented as mean ± SE (p-value).
      NoneMinor MedicalMinor SurgicalGraft/ACL Tear
      ACL-QOL81.3 ± 0.9 (ref)76.9 ± 2.7 (0.13)70.8 ± 4.3 (0.02)54.0 ± 3.6 (<0.01)
      IKDC89.4 ± 0.6 (ref)86.8 ± 1.6 (0.12)85.4 ± 2.2 (0.08)75.1 ± 2.4 (<0.01)
      KOOS Pain93.1 ± 0.4 (ref)92.1 ± 1.3 (0.45)89.3 ± 1.8 (0.04)87.5 ± 2.2 (<0.01)
      KOOS Symptoms86.4 ± 0.6 (ref)85.5 ± 1.8 (0.64)82.4 ± 2.8 (0.18)76.7 ± 3.1 (<0.01)
      KOOS ADLs97.4 ±0.3 (ref)96.5 ± 0.9 (0.29)98.0 ± 1.2 (0.65)94.0 ± 1.2 (<0.01)
      KOOS Sport87.6 ± 0.8 (ref)84.9 ± 2.3 (0.26)81.0 ± 3.2 (0.05)72.4 ± 3.9 (<0.01)
      KOOS QOL78.3 ± 0.9 (ref)72.8 ± 2.7 (0.06)71.6 ± 4.2 (0.12)53.0 ± 4.8 (<0.01)
      P-values represent statistical significance in pooled mean scores between each complication group and the group with no complications (i.e., reference level).
      SE = standard error.
      Ref = reference level, no p-value available.

      Discussion

      The most important finding from this study was that the addition of LET to a hamstring tendon autograft ACLR in patients under the age of 25 years significantly reduces graft rupture rates compared to ACLR alone (4% vs. 11%), with no significant increase in any associated serious adverse events. When adverse events were categorized, there was a significantly lower proportion of patients with graft or contralateral ACL tears in the LET group. Additionally, there was no significant difference in the proportion of patients with minor medical adverse events (which resolved spontaneously), other minor surgical adverse events (i.e., meniscal tears, stiffness, hardware irritation and removal), or overall reoperation rates between those who had the ACLR alone and those with ACLR+LET.
      We previously reported that the difference in graft failure between groups did not result in between group differences in the PROMs collected at 6, 12 and 24 months.
      • Getgood A.M.J.
      • Bryant D.M.
      • Litchfield R.
      • et al.
      Lateral Extra-articular Tenodesis Reduces Failure of Hamstring Tendon Autograft Anterior Cruciate Ligament Reconstruction: 2-Year Outcomes From the STABILITY Study Randomized Clinical Trial.
      However, the analysis from this paper clearly shows that a more severe complication such as graft rupture or contralateral ACL injury does result in significantly reduced PROMs. In contrast, the effect of minor medical and minor surgical complications was washed out when patients with 24-month complications were excluded. This indicates that the negative influence of these complications on PROMs in our current analysis was likely due to the recency of the event rather than the severity of the complication. However, patients who experience a graft rupture or contralateral ACL tear appear to have a significantly lower PROMs, regardless of the time at which the tear occurs. For this analysis, we grouped graft rupture and contralateral ACL tears into one composite outcome (graft/ACL tear) to increase the statistical power to investigate the influence of having a secondary ACL injury event on patient reported outcome scores.
      Furthermore, we did not see an increased rate of septic arthritis to be observed with the addition of LET, as has been suggested in a previous study
      • Sonnery-Cottet B.
      • Archbold P.
      • Zayni R.
      • et al.
      Prevalence of Septic Arthritis After Anterior Cruciate Ligament Reconstruction Among Professional Athletes.
      We did however observe a significant increase in pain up until 3 months post-operative with the addition of the LET, likely as a result of the extra surgery performed. Importantly, these differences resolved by 6 months post-operative.
      Similar to previous studies, this large, randomized trial found a higher rate of hardware related discomfort in the ACLR+LET group, ultimately requiring removal of the staple. This secondary surgery should be placed in the context of the reduced rate of graft rupture, as well as total re-operation rates. It is possible that the issue of LET staple removal could be mitigated with use of an alternative fixation device, however this might negatively influence the cost effectiveness of the procedure and may impact efficacy. Despite 10 patients in the LET group having a re-operation for LET staple removal, the overall rate of re-operation between groups was similar between groups and slightly higher for the ACLR alone group (18%) versus the ACLR+LET group (15%), likely due to the higher rates of graft rupture in the former.
      In a study by Sonnery-Cottet et al., they observed that the addition of an LET seemed to be protective of meniscal repair.
      • Sonnery-Cottet B.
      • Praz C.
      • Rosenstiel N.
      • et al.
      Epidemiological Evaluation of Meniscal Ramp Lesions in 3214 Anterior Cruciate Ligament–Injured Knees From the SANTI Study Group Database: A Risk Factor Analysis and Study of Secondary Meniscectomy Rates Following 769 Ramp Repairs.
      This may be attributable to the improved kinematics of the knee, that have been shown in cadaveric studies when lateral procedures are added to an ACL reconstruction.
      • Inderhaug E.
      • Stephen J.M.
      • Williams A.
      • Amis A.A.
      Biomechanical Comparison of Anterolateral Procedures Combined with Anterior Cruciate Ligament Reconstruction.
      However, the rate of new mensical tears and re-tears was not different between groups in our study. Furthermore, concerns of lateral over constraint and lateral compartment osteoarthritis are often suggested to be associated with lateral procedures. The evidence to support the genesis of osteoarthritis being associated with meniscal loss far outweighs that of the anecdotal concerns of OA development being associated with LET. Two European studies with greater than 20 years follow up have not demonstrated an increased rate of OA development with the addition of LET and a

      Pearle A, Bergfeld J. Extraarticular reconstruction in ACL deficient knee. American Orthopaedic Society for Sports Medicine. Published online 1992.

      ,
      • Webster K.E.
      • Feller J.A.
      • Leigh W.B.
      • Richmond A.K.
      Younger patients are at increased risk for graft rupture and contralateral injury after anterior cruciate ligament reconstruction.
      meta-analysis also found no correlation between LET and OA..
      • Devitt B.M.
      • Bouguennec N.
      • Barfod K.W.
      • Porter T.
      • Webster K.E.
      • Feller J.A.
      Combined anterior cruciate ligament reconstruction and lateral extra-articular tenodesis does not result in an increased rate of osteoarthritis: a systematic review and best evidence synthesis.
      ,
      • Pernin J.
      • Verdonk P.
      • Si Selmi T.A.
      • Massin P.
      • Neyret P.
      Long-term follow-up of 24.5 years after intra-articular anterior cruciate ligament reconstruction with lateral extra-articular augmentation.
      ,
      • Zaffagnini S.
      • Marcheggiani Muccioli G.M.
      • Grassi A.
      • et al.
      Over-the-top ACL Reconstruction Plus Extra-articular Lateral Tenodesis With Hamstring Tendon Grafts: Prospective Evaluation With 20-Year Minimum Follow-up.
      We suggest that the benefits of greater knee stability, reduced graft rupture and protection of meniscal integrity that is afforded to ACLR when an LET is added, far outweighs any transient increase in procedure related knee pain or hardware removal. However, we do recognize the need for longer-term follow-up of our patients to ensure that no differences in lateral compartment degenerative changes are observed.
      Importantly, two systematic reviews in 2021 have indicated the benefits of lateral procedures being added to ACLR
      • Beckers L.
      • Vivacqua T.
      • Firth A.D.
      • Getgood A.M.J.
      Clinical outcomes of contemporary lateral augmentation techniques in primary ACL reconstruction: a systematic review and meta-analysis.
      ,
      • Kunze K.N.
      • Manzi J.
      • Richardson M.
      • et al.
      Combined Anterolateral and Anterior Cruciate Ligament Reconstruction Improves Pivot Shift Compared With Isolated Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis of Randomized Controlled Trials.
      . Kunze and colleagues’ review of 46 studies reported that while the evidence was heterogenous, ALL reconstruction improved pivot shift outcomes (post-operative knee stability) and resulted in comparable clinical and functional outcomes the ACLR alone
      • Kunze K.N.
      • Manzi J.
      • Richardson M.
      • et al.
      Combined Anterolateral and Anterior Cruciate Ligament Reconstruction Improves Pivot Shift Compared With Isolated Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis of Randomized Controlled Trials.
      . Beckers and colleagues reviewed 11 randomized controlled trials and prospective cohort studies which suggested that additional lateral augmentation reduced rates of graft rupture (3% versus 12%) and rotational laxity (6% versus 14%) as compared to isolated ACLR
      • Beckers L.
      • Vivacqua T.
      • Firth A.D.
      • Getgood A.M.J.
      Clinical outcomes of contemporary lateral augmentation techniques in primary ACL reconstruction: a systematic review and meta-analysis.
      . Both groups had similar IKDC and Tegner scores, while better Lysholm scores were reported with lateral augmentation
      • Beckers L.
      • Vivacqua T.
      • Firth A.D.
      • Getgood A.M.J.
      Clinical outcomes of contemporary lateral augmentation techniques in primary ACL reconstruction: a systematic review and meta-analysis.
      . Several studies investigating lateral extra articular procedures have been published in the past year since these reviews. Two retrospective studies reported significantly lower rates of revision in young athletes who had ACLR with two different versions of LET (Arnold Coker modification to MacIntosh procedure and Lemaire procedure) versus isolated ACLR
      • Borque K.
      • Jones M.
      • Laughlin M.
      • et al.
      Lateral Extra-Articular Tenodesis Reduces the Rate of Revision Anterior Cruciate Ligament Reconstruction in Elite Athletes.
      ,
      • Monaco E.
      • Carrozzo A.
      • Saithna A.
      • et al.
      Isolated ACL Reconstruction Versus ACL Reconstruction Combined With Lateral Extra-articular Tenodesis: A Comparative Study of Clinical Outcomes in Adolescent Patients.
      . A cohort study from the SANTI study group of over 300 athletes reported athletes under 21 years old who had isolated ACLR versus those who had a lateral extra-articular procedure.
      • Hopper G.P.
      • Pioger C.
      • Philippe C.
      • et al.
      Risk Factors for Anterior Cruciate Ligament Graft Failure in Professional Athletes: An Analysis of 342 Patients With a Mean Follow-up of 100 Months From the SANTI Study Group.
      Lastly, a 2022 ISAKOS consensus statement reached an unanimous agreement that adding LET to ACLR in particular cases (active young (<25) athletes, hyperlaxity, increased rotatory laxity, and revisions) could be associated with an increased return to sport rate in soccer.
      • Figueroa D.
      • Arce G.
      • Joao Espregueira M.
      • et al.
      Return to Sport Soccer after Anterior Cruciate Ligament Reconstruction: ISAKOS Consensus.
      This study has limitations. First, patients were not blinded to their treatment allocation. This was not possible due to the location of skin incisions, however, this was mitigated somewhat by the blinding of outcome assessors. Second, this study only investigated patients who underwent ACLR with a hamstring tendon autograft. The use of a bone patella tendon bone autograft may confer different results.
      • Mohtadi N.
      • Chan D.
      • Barber R.
      • Oddone Paolucci E.
      A Randomized Clinical Trial Comparing Patellar Tendon, Hamstring Tendon, and Double-Bundle ACL Reconstructions: Patient-Reported and Clinical Outcomes at a Minimal 2-Year Follow-up.
      ,
      • Mohtadi N.G.
      • Chan D.S.
      A Randomized Clinical Trial Comparing Patellar Tendon, Hamstring Tendon, and Double-Bundle ACL Reconstructions: Patient-Reported and Clinical Outcomes at 5-Year Follow-up.
      Further, we did make attempts to ensure that graft size was at least 8mm in diameter which is in line with recent data suggesting that grafts less than 8mm are associated with increased risks of graft failure.
      • Magnussen R.A.
      • Lawrence J.T.R.
      • West R.L.
      • Toth A.P.
      • Taylor D.C.
      • Garrett W.E.
      Graft size and patient age are predictors of early revision after anterior cruciate ligament reconstruction with hamstring autograft.
      Third, because of the age limits placed on the eligibility criteria, we are uncertain whether the study findings apply to patients under the age of 14 or those over 25 years of age. However, the 14-25 age demographic is extremely important due to their level of competitive sport participation and the high incidence of graft rupture reported in this population.
      • Kaeding C.C.
      • Pedroza A.D.
      • Reinke E.K.
      • et al.
      Risk factors and predictors of subsequent ACL injury in either knee after ACL reconstruction: Prospective analysis of 2488 primary ACL reconstructions from the MOON cohort.
      ,
      • Webster K.E.
      • Feller J.A.
      Exploring the High Reinjury Rate in Younger Patients Undergoing Anterior Cruciate Ligament Reconstruction.
      Fourth, because this was a large pragmatic trial, we were unable to ensure or measure compliance to physical therapy recommendations nor standardization of rehabilitation across all study sites, although patients were provided with standardized verbal and written instructions as per the agreed upon rehabilitation protocol. Lastly, we were unable to control for the time from surgery to return to sport. We reported six complications directly related to difficulties with the LET graft during surgery. However, this may have unfairly highlighted issues related to harvesting tissue for a LET. There were likely issues related to harvesting the ACL graft which were not reported since it is not a new procedure, and such events were unrelated to the study.

      Conclusion

      The addition of LET to hamstring tendon autograft ACLR in young patients at high risk of graft re-injury results in a statistically significant, clinically relevant reduction in graft rupture. Whilst the addition of LET to an ACLR may result in increased rates of hardware irritation, there was no significant increase in overall rates of minor medical adverse events, minor surgical events, or overall re-operation rates. The concerns in the literature regarding complications associated with a LET were not observed in this study.

      Declaration of interests

      The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:
      Alan Getgood reports financial support was provided by International Society for Arthroscopic Knee Surgery and Orthopaedic Sports Medicine (ISAKOS). Alan Getgood reports a relationship with Canadian Institutes of Health Research that includes: funding grants. Alan Getgood reports a relationship with National Institutes of Health that includes: funding grants. Alan Getgood reports a relationship with Academic Medical Organization of Southwestern Ontario that includes: funding grants. Alan Getgood reports a relationship with Canadian Foundation for Innovation that includes: funding grants. Alan Getood reports a relationship with Ontario Research Foundation that includes: funding grants. Alan Getgood reports a relationship with Smith and Nephew that includes: consulting or advisory, royalties and funding grants. Alan Getgood reports a relationship with Graymont Inc that includes: royalties. Alan Getgood reports a relationship with Ossur that includes: consulting or advisory. Alan Getgood reports a relationship with Olympus that includes: consulting or advisory. Robert Litchfield reports a relationship with Smith and Nephew that includes: consulting or advisory. Robert McCormack reports a relationship with Canadian Institutes of Health Research that includes: funding grants. Robert McCormack reports a relationship with National Institutes of Health that includes: funding grants. Robert McCormack reports a relationship with Orthopaedic Trauma Association that includes: funding grants. Robert McCormack reports a relationship with Physicians’ Services Inc Foundation that includes: funding grants. Robert McCormack reports a relationship with Bioventus that includes: speaking and lecture fees. Robert McCormack reports a relationship with Pendopharm that includes: speaking and lecture fees. Robert McCormack reports a relationship with Smith and Nephew that includes: speaking and lecture fees. Robert McCormack reports a relationship with Sanofi that includes: speaking and lecture fees. Tim Spalding reports a relationship with Conmed that includes: consulting or advisory and speaking and lecture fees. Tim Spalding reports a relationship with Smith and Nephew that includes: speaking and lecture fees. Tim Spalding reports a relationship with Joint Operations that includes: speaking and lecture fees. Peter Verdonk reports a relationship with Conmed that includes: consulting or advisory and speaking and lecture fees. Peter Verdonk reports a relationship with Smith and Nephew that includes: speaking and lecture fees. Laurie Hiemstra reports a relationship with Conmed that includes: consulting or advisory and speaking and lecture fees. Hana Marmura reports a relationship with Canadian Institutes of Health Research that includes: funding grants. Hana Marmura reports a relationship with Western University Bone and Joint Institute that includes: funding grants.

      Uncited References

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      Lateral Extra-articular Tenodesis Contributes Little to Change In Vivo Kinematics After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial.
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      Acknowledgments

      The Stability Study was funded by a research award from the International Society for Arthroscopic Knee Surgery and Orthopaedic Sports Medicine (ISAKOS).
      This paper was awarded the Jan Gillquist Scientific Research Award at the 2019 International Society for Arthroscopic Knee Surgery and Orthopaedic Sports Medicine (ISAKOS) Congress.

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