Complications and Adverse Events of a Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction
Mohtadi N, Barber R, Chan D, and Paolucci EO. Clin J Sports Med. 2015. [Epub Ahead of Print].
Take Home Message: Of 330 patients who underwent an anterior cruciate ligament (ACL) reconstruction surgery, 27% reported an adverse event due to surgery within 2 years but only 2 adverse events (0.6%) were considered major complications and 24 (7%) required a repeat surgery. This suggests that overall, ACL reconstruction surgery is generally safe and the adverse events which do occur can be treated relatively successfully.
We often focus on the short-term benefits of an anterior cruciate ligament (ACL) reconstruction or the long-term outcomes of ACL reconstruction but we know very little about the adverse events (complications) within the first 2 years after surgery. By better understanding this, clinicians will be better equipped to counsel patients and explore strategies to prevent these adverse events. Therefore, Mohtadi and colleagues completed a prospective, double-blind randomized clinical trial and identified and reported all adverse events following ACL reconstruction using 3 different grafts. A post about the primary results of this clinical trial is available on Sports Med Res. A total of 330 patients (183 males, 29 mean years of age) were randomly assigned to a patellar-tendon, quadruple-stranded hamstring tendon, or double-bundle hamstring tendon group. Following ACL reconstruction all patients completed similar rehabilitation protocols and were contacted at 2 weeks, 3 and 6 months, and 1 and 2 years post-surgery. Researchers contacted patients by phone and asked about any adverse events. If an adverse event was reported, the patient came in to see one of the research team members. Overall, 88 patients (27%) reported 100 adverse events: 24%, 32%and 44% in patellar-tendon, quadruple-stranded hamstring tendon, or double bundle hamstring tendon groups, respectively. Twenty-four patients (7%) required an additional surgery (6 to 8% in each group). Hamstring injury, meniscal tear, persistent effusion, and arthrofibrosis were the most common adverse events. Among the surgeries, 12 (4%) were performed for a meniscal tear and 9 (3%) were for intra-articular scarring. Only 12 patients (4%) reported more than 1 adverse event. Graft type did not influence the number of adverse events. Two major complications (pulmonary embolism and septic arthritis) were reported and were resolved with emergency care.
Ultimately, the data presented shows 2 primary points. Firstly, ACL reconstruction surgery should be considered relatively safe as major complications (2 patients [0.6%]) were uncommon. Further, no significant difference was found between graft types; however, it should be noted that information regarding surgeon experience was unclear, making it difficult to understand if an interaction exists between surgeon experience and graft type selection. While 100 adverse events were reported, these were relatively common, treatable events following ACL reconstruction including hamstring injury, meniscal tear, persistent effusion, and arthrofibrosis. Secondly, while not very common, 7% of patients required additional procedures to address their adverse events. This is important for clinicians to communicate to their patients both before and after reconstruction. While the incidence was low, if clinicians can communicate this possibility to the patient, perhaps patients can better understand, anticipate, and rebound from needing additional procedures. Ultimately, the current study serves to alert clinicians to the possible adverse events their patient may encounter during the recovery process from ACL reconstruction surgery. By counseling and communicating these possibilities perhaps our patients can be better prepared to meet and overcome the challenges of recovering from a surgery such as this.
Questions for Discussion: Do you counsel your ACL rupture patients on the potential complications of ACL reconstruction surgery? When and how do you approach this subject?
Written by: Kyle Harris
Reviewed by: Jeffrey Driban
ACL Graft Type May Not Matter When Attempting to Improve Patient-Reported Outcome 2-Years Post-Surgery