Acute Anterior Cruciate Ligament Rupture: Repair or Reconstruction? Five-Year Results of a Randomized Controlled Clinical Trial

Abstract

Background: High-level evidence for short–term outcomes of contemporary anterior cruciate ligament (ACL) suture repair (ACLSR) in comparison with those of ACL reconstruction (ACLR) is scarce. High-level evidence for mid- and long–term results is lacking, whereas outcomes of ACLSR in several historical studies were shown to deteriorate at midterm follow–up after initial good short–term outcomes. Hypothesis: Contemporary ACLSR is noninferior to ACLR in the treatment of acute ACL rupture in terms of patient self–reported outcomes at 5 years postoperatively. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 48 patients were enrolled in the study and, after stratification and randomization, underwent either dynamic augmented (DA) ACLSR or anatomic single–bundle ACLR. The primary outcome measure was the International Knee Documentation Committee 2000 (IKDC) subjective score (IKDCs). Furthermore, the Knee injury and Osteoarthritis Outcome Score (KOOS), Tegner Activity Scale score (TAS), visual analog scale score for satisfaction (VASs), IKDC physical examination score (IKDCpe), limb symmetry index for quadriceps (LSIq) and hamstrings (LSIh) strength and jump test battery (LSIj), Kellgren-Lawrence grade of osteoarthritis (OA), and rate of adverse events were recorded. Analyses were based on an intention–to–treat principle. Results: The lower limit of the 2–sided 95% CI for the median IKDCs of the DA ACLSR group (n = 23; 75.9) was lower than the prespecified noninferiority margin (n = 21; 86.6). Therefore, the null hypothesis was rejected. However, the upper limit of the 2–sided 95% CI of the DA ACLSR group (100.0) was higher than the median IKDCs of the ACLR group (96.6), rendering the result for noninferiority inconclusive. No statistical difference was found between groups for median IKDCs (repair, 90.2; reconstruction, 96.6). Furthermore, no statistically significant differences were found for any of the secondary outcome measures for the DA ACLSR compared with the ACLR group: KOOS Symptoms, 92.9 versus 96.4; KOOS Pain, 100 versus 97.2; KOOS Activities of Daily Living, 100 versus 100; KOOS Sport and Recreation, 85.0 versus 100; TAS score, 7.0 versus 6.5; VASs, 9.2 versus 8.7; IKDCpe, 81.8% versus 100%; LSIq, ≥91.6 versus ≥88.2; LSIh, ≥95.1 versus ≥90.7; LSIj, ≥94.2 versus ≥97.6; OA grade 0, 90.9% versus 77.8%; clinical ACL failure rate, 20.8% versus 27.2%; and repeat surgery rate, 37.5% versus 20.0%, respectively. Conclusion: It remains inconclusive whether the effectiveness of DA ACLSR is noninferior to that of ACLR in terms of subjective patient–reported outcomes as measured using the IKDCs. Although DA ACLSR may be a viable treatment option for patients with acute ACL rupture, caution must be exercised when considering this treatment for young, active patients, corresponding to the present study population.

Knee

“…As stated by the authors in this excellent paper from the Netherlands , while the initial short-term outcomes of anterior cruciate ligament (ACL) repair have been reported, there are few studies of longer-term outcomes of ACL repair, especially when compared to reconstruction. 8 There remains no high-level evidence to support improved outcomes of ACL repair over ACL reconstruction in the long term. The authors of this randomized controlled trial hypothesized that ACL repair was not inferior to ACL reconstruction in terms of patient-reported outcome measures (PROMs) at five years postoperatively.…”

ACL Blasts From Past to Present

“…Several of the proposed techniques have been investigated in randomized trials published in AJSM. 18,19,22,37 Murray and colleagues 37 reported 2-year results of a randomized trial, in this case comparing 64 cases of bridgeenhanced ACL repair (BEAR) to 35 ACL reconstructions done mostly using the autograft hamstring technique. The patients who had the BEAR met noninferiority standards for IKDC Subjective Knee Score and instrumented anterior laxity while demonstrating superior attainment of hamstring strength.…”

“…Hoogeslag and colleagues 19 recently reported 5-year follow-up in their randomized trial comparing DIS repair with single-bundle reconstruction with a 4-strand semitendinosus graft. The result of their noninferiority comparison of the primary outcome, the IKDC Subjective Knee Score, was inconclusive.…”

“…Several of the proposed techniques have been investigated in randomized trials published in AJSM . 18,19,22,37…”

“…The result of their noninferiority comparison of the primary outcome, the IKDC Subjective Knee Score, was inconclusive. They therefore stated, “Although DA (DIS) ACLR may be a viable treatment option for patients with acute ACL rupture, caution must be exercised when considering this treatment for young, active patients, corresponding to the present study population.” 19(p1786) In my opinion, although some results of contemporary ACL repair techniques are encouraging, there is enough uncertainty 12 that widespread adoption would not seem to be warranted until more clinical evidence has been gathered.…”