Anterior cruciate ligament reconstruction combined with anterolateral ligament reconstruction using hamstring autograft versus anterior cruciate ligament reconstruction using bone-patellar tendon-bone autograft: a randomised controlled trial with 5-year follow-up

Abstract

Background: Anterior Cruciate Ligament (ACL) rupture is common knee injury. Although ACL reconstruction (ACLR) is standard, graft failure rates remain high in young active patients. This study investigated whether combining ACLR with anterolateral ligament (ALL) reconstruction (ALLR) reduces grafts failure compared with ACLR.

Methods: In this prospective, single-centre, randomised controlled trial conducted at the Santy Orthopedic Center in Lyon, France, patients aged 18-35 years with symptomatic ACL rupture were randomly allocated (1:1) to ACL + ALL reconstruction using hamstring tendon autograft (ACLR + ALLR) or ACLR with bone-patellar tendon-bone autograft (ACLR). Randomisation was performed with a block size of four using telematic software by an independent study coordinator, with concealed allocation. Surgeons were informed of the assigned procedure on the morning of surgery. Outcome assessors were not blinded. The primary outcome was graft failure at 5 years, assessed clinically and by magnetic resonance imaging (MRI) by an independent sports medicine physicians not involved in the index surgery. Efficacy analyses were performed on the Full Analysis Set in accordance with the intention-to-treat principle, while safety analyses were conducted on the Safety Set. Trial registration: ClinicalTrials.gov, ID NCT03740022. The trial has been completed.

Findings: Between November 11, 2016, and January 20, 2020, 593 patients were randomized (297 assigned to ACLR + ALLR and 296 to ACLR). The mean age was 25.0 years (SD 4.5); 447 (75%) participants were male and 146 (25%) female. Of these 593 patients, 556 (94%) completed a mean 5-year follow-up. Graft failure occurred in 12/283 (4.2%) with ACLR + ALLR versus 28/273 (10.3%) with ACLR (p = 0.006; adjusted odds ratio 2.54 [95% CI 1.27; 5.36]-p = 0.008). The number needed to treat was 17 overall, and 9 in patients younger than 25 years.

Interpretation: In our study of young, active adults with ACL rupture, who are considered high-risk for graft failure, combining ACL reconstruction with anterolateral ligament reconstruction (ACLR + ALLR) significantly decreased graft failure compared with ACLR. These results suggest that ACLR + ALLR might be beneficial for young or highly active individuals and provide a basis for future research to refine patient selection, evaluate long-term outcomes beyond five years, and explore benefits in other subgroups of patients with ACL injuries.

Funding: GCS Ramsay Santé pour l'Enseignement et la Recherche funds the scientific activity at the Santy center.

Keywords: ACL; Clinical Outcomes; Graft failure; LEAP; Randomised controlled trial; Reoperation rate.

Fig. 1

ACL reconstruction techniques. (A) ACL reconstruction using bone-patellar tendon-bone (BPTB) autograft, reprinted with permission. (B) Combined ACL reconstruction (ACLR) and anterolateral ligament reconstruction (ALLR) using hamstring tendon autografts, reprinted with permission.

Fig. 2

Trial profile. ACLR, anterior cruciate ligament reconstruction; ALL, anterolateral ligament.

Fig. 3

Forest plot shows odds ratios (ORs) with 95% CIs from a multivariable logistic regression in the Full Analysis Set (n = 556; events = 40). Covariates included planned arm (isolated ACL reconstruction [ACLR] versus ACLR combined with anterolateral ligament reconstruction [ACLR + ALLR, reference]), age (<25 versus ≥25 years [reference]), presence of meniscal lesions (yes versus no [reference]), sex (male versus female [reference]), BMI class (<25 versus ≥25 kg/m² [reference]), preoperative Tegner score (≥7 versus <7 [reference]), and sport type at injury (no pivot/no contact; no sport; pivot/contact versus pivot [reference]). Squares denote point estimates; horizontal bars denote 95% CIs; the vertical line indicates no effect (OR = 1).

Fig. 4

Kaplan Meier plot. ACLR, anterior cruciate ligament reconstruction; ALLR, anterolateral ligament reconstruction; GF, graft failure. The Kaplan–Meier curves account for censoring after 48 months for patients lost to follow-up or event-free at their last assessment. The overall graft failure rate of 7.2% (40/556) in the FAS reflects observed events at 5 years, consistent with the survivorship estimate.

Fig. 5

Adjusted hazard ratios for graft failure over 5 years. Forest plot shows hazard ratios (HRs) with 95% CIs from a Cox proportional hazards model in the Full Analysis Set (n = 556; events = 40). Covariates were planned arm (isolated anterior cruciate ligament reconstruction [ACLR] versus ACLR combined with anterolateral ligament reconstruction [ACLR + ALLR, reference]), age (<25 versus ≥25 years [reference]), sex (male versus female [reference]), body-mass index class (<25 versus ≥25 kg/m² [reference]), presence of meniscal lesions (yes versus no [reference]), preoperative Tegner score (≥7 versus <7 [reference]), and sport type at injury (no pivot/no contact; no sport; pivot/contact versus pivot [reference]). Squares denote point estimates; horizontal bars denote 95% CIs; the vertical line indicates no effect (HR = 1). HR, hazard ratio; CI, confidence interval.

Fig. 6

KOOS Subscales values at 5 years follow-up.