Five-year clinical outcomes of a randomized trial of anterior cruciate ligament treatment strategies: an evidence-based practice paper.

REFERENCE/CITATION: Frobell RB, Roos HP, Roos EM, Roemer FW, Ranstam J, Lohmander LS. Treatment for acute anterior cruciate ligament tear: five year outcome of randomised trial. BMJ. 2013;346:F232. CLINICAL QUESTION: Does early anterior cruciate ligament (ACL) reconstruction with rehabilitation lead to better patient-reported outcomes and a lower incidence of osteoarthritis at 5 years postinjury compared with delayed ACL reconstruction with rehabilitation? STUDY SELECTION: This randomized controlled trial with extended follow-up at 5 years postrandomization was conducted in 2 Swedish orthopaedic departments. DATA EXTRACTION: The authors studied a total of 121 moderately active adults (age = 18-35 years) with an acute ACL rupture in a knee with no other history of trauma. Excluded were patients with a collateral ligament rupture, full-thickness cartilage defect, or extensive meniscal fixation. One patient assigned to the early ACL-reconstruction group did not attend the 5-year follow-up visit. Patients were randomly assigned to (1) an early ACL reconstruction plus structured rehabilitation group (n = 62, surgery within 10 weeks of injury) or (2) optional-delayed ACL reconstruction plus structured rehabilitation group (n = 59). The primary outcome measure was change in the average of 4 out of 5 subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS). The authors also assessed crude KOOS (combined 4 subscales), KOOS subscale scores, general physical and mental health (Short-Form 36), activity level (Tegner Activity Scale), mechanical knee stability (Lachman and pivot shift tests), meniscal surgery status, and presence of knee osteoarthritis on radiographs. MAIN
RESULTS: Among patients randomized to the optional-delayed ACL-reconstruction group, 30 (51%) opted for an ACL reconstruction. The treatment groups had comparable 5-year patient-reported outcomes and changes in patient-reported outcomes (eg, knee pain, knee symptoms, activities of daily living, sport and recreational levels, knee-related quality of life, general physical health, and general mental health). Patients in the optional-delayed ACL-reconstruction group had greater mechanical knee instability than patients who received early ACL reconstruction; however, this was primarily among the patients opting for conservative management alone. In the overall sample, 61 knees (51%) required meniscal surgery over 5 years, regardless of treatment group. At 5 years, radiographs were available for 113 patients (93%). Overall, 29 patients (26%) had knee osteoarthritis at 5 years. Specifically, 13 patients (12%) developed tibiofemoral radiographic osteoarthritis (9 patients [16%] in the early ACL-reconstruction group, 4 [7%] in the optional-delayed ACL-reconstruction group) and 22 (19%) developed patellofemoral osteoarthritis (14 patients [24%] in the early ACL-reconstruction group, 8 [15%] in the optional-delayed ACL-reconstruction group). Patients with patellar tendon grafts (n = 40) had a greater incidence of ipsilateral patellofemoral osteoarthritis than patients with hamstrings tendon grafts (n = 51), but the 2 groups had similar incidences of ipsilateral tibiofemoral osteoarthritis. Six knees (5%) had both tibiofemoral and patellofemoral osteoarthritis.
CONCLUSIONS: Early ACL reconstruction plus rehabilitation did not provide better results at 5 years compared with optional-delayed ACL reconstruction plus rehabilitation. Furthermore, the authors found no radiographic differences among patients with early ACL reconstruction, delayed ACL reconstruction, or no ACL reconstruction (rehabilitation alone).

RCT Entities:   Population Interventions Outcomes