title: Complications and Adverse Events of a Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction.
abstract: 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.
  
  
  METHODS
  Prospective, double-blind randomized clinical trial. Patients and the independent trained examiner were blinded to treatment allocation.
  
  
  METHODS
  University-based orthopedic referral practice.
  
  
  METHODS
  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.
  
  
  METHODS
  Patients were equally distributed to patellar tendon (PT), quadruple-stranded hamstring tendon (HT), and double-bundle (DB) hamstring autograft ACL reconstruction.
  
  
  METHODS
  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.
  
  
  METHODS
  Level 1 (therapeutic studies).
  
  
  CONCLUSIONS
  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.
authors.affiliation: *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.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Mohtadi
authors.forename: Rhamona
authors.initials: R
authors.lastname: Barber
authors.forename: Denise
authors.initials: D
authors.lastname: Chan
authors.forename: Elizabeth Oddone
authors.initials: EO
authors.lastname: Paolucci
mesh_terms: D000293:Adolescent; D000328:Adult; D000416:Alberta / Q000453:epidemiology; D059549:Anterior Cruciate Ligament Reconstruction / Q000009:adverse effects* / Q000379:methods / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology* / Q000209:etiology; D055815:Young Adult