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Athymic Rat Model for Evaluation of Engineered Anterior Cruciate Ligament Grafts
Published on: March 26, 2015
Complications and Adverse Events of a Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction
Nicholas Mohtadi1, Rhamona Barber, Denise Chan
1*Sport Medicine Centre, Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada; and †Departments of Surgery and Community Health Sciences, Faculty of Medicine, University of Calgary, Calgary, Alberta, Canada.
Objective:
Complications/adverse events of anterior cruciate ligament (ACL) surgery are underreported, despite pooled level 1 data in systematic reviews. All adverse events/complications occurring within a 2-year postoperative period after primary ACL reconstruction, as part of a large randomized clinical trial (RCT), were identified and described.
Design:
Prospective, double-blind randomized clinical trial. Patients and the independent trained examiner were blinded to treatment allocation.
Setting:
University-based orthopedic referral practice.
Patients:
Three hundred thirty patients (14-50 years; 183 males) with isolated ACL deficiency were intraoperatively randomized to ACL reconstruction with 1 autograft type. Graft harvest and arthroscopic portal incisions were identical.
Intervention:
Patients were equally distributed to patellar tendon (PT), quadruple-stranded hamstring tendon (HT), and double-bundle (DB) hamstring autograft ACL reconstruction.
Main Outcome Measures:
Adverse events/complications were patient reported, documented, and diagnoses confirmed.
Results:
Two major complications occurred: pulmonary embolism and septic arthritis. Twenty-four patients (7.3%) required repeat surgery, including 25 separate operations: PT = 7 (6.4%), HT = 9 (8.2%), and DB = 8 (7.3%). Repeat surgery was performed for meniscal tears (3.6%; n = 12), intra-articular scarring (2.7%; n = 9), chondral pathology (0.6%; n = 2), and wound dehiscence (0.3%; n = 1). Other complications included wound problems, sensory nerve damage, muscle tendon injury, tibial periostitis, and suspected meniscal tears and chondral lesions. Overall, more complications occurred in the HT/DB groups (PT = 24; HT = 31; DB = 45), but more PT patients complained of moderate or severe kneeling pain (PT = 17; HT = 9; DB = 4) at 2 years.
Conclusions:
Overall, ACL reconstructive surgery is safe. Major complications were uncommon. Secondary surgery was necessary 7.3% of the time for complications/adverse events (excluding graft reinjury or revisions) within the first 2 years.
Level Of Evidence:
Level 1 (therapeutic studies).
Clinical Relevance:
This article reports on the complications/adverse events that were prospectively identified up to 2 years postoperatively, in a defined patient population participating in a large double-blind randomized clinical trial comparing PT, single-bundle hamstring, and DB hamstring reconstructions for ACL rupture.
