RESUMEN
PURPOSE: To compare outcomes after anterior cruciate ligament reconstruction (ACLR) with bone marrow aspirate concentrate (BMAC), demineralized bone matrix (DBM), and suture tape augmentation (STA) versus ACLR without biological augmentation or STA. METHODS: We performed a prospective randomized controlled trial at a single institution to compare ACLR with BMAC, DBM, and STA (group A) versus ACLR without biological augmentation or STA (group NA). The study sought to include 100 patients. Skeletally mature patients younger than 25 years received quadriceps tendon autograft, whereas patients aged 25 years or older underwent allograft ACLR with an all-inside technique. Patients with concomitant meniscal pathologies were included. The primary outcomes compared were range of motion (ROM), limb symmetry, and patient-reported outcomes. Secondary outcomes included radiographic outcomes and surgical complications. Univariate and mixed-model regression analyses were used to compare outcomes. RESULTS: Fifty-nine patients were included (29 patients in group A [11 female patients, 38%] and 30 patients in group NA [15 female patients, 50%]). Early ROM at 6 weeks (125° of flexion vs 109° of flexion, P < .0001) and limb symmetry at 12 weeks (80.6% vs 36.7% [delta, 43.9%], P < .001) were significantly improved in group A. At 2 years, International Knee Documentation Committee scores were similar (91.1 ± 12.7 vs 85.3 ± 10.8, P = .109). Quality-of-life subscores of the Knee Injury and Osteoarthritis Outcome Score were significantly enhanced in group A (85.2 ± 20.9 vs 72.1 ± 20.4, P = .042). In 22 patients (12 in group A and 10 in group NA), computed tomography scans were obtained at 6 months to compare bone tunnel healing. Overall, the mean increase in bone tunnel diameter was significantly smaller in group A than in group NA. No difference in graft rerupture or reoperation rate was observed. Reoperations were performed for stiffness in 7 of 59 patients (11.9%) (3 [10%] in group A vs 4 [13%] in group NA; P > .999). CONCLUSIONS: There were no differences in International Knee Documentation Committee scores between groups at 2-year follow-up. Functional outcomes including early ROM and limb symmetry were significantly improved in patients who received ACLR with BMAC, DBM, and STA. LEVEL OF EVIDENCE: Level II, randomized controlled trial.