Augmentation of ACL Autograft Reconstruction With an Amnion Collagen Matrix Wrap and Bone Marrow Aspirate Concentrate: A Pilot Randomized Controlled Trial With 2-Year Follow-up.

BACKGROUND: It is theorized that the lack of a synovial lining after anterior cruciate ligament (ACL) injury and ACL reconstruction (ACLR) contributes to slow ligamentization and possible graft failure. Whether graft maturation and incorporation can be improved with the use of a scaffold requires investigation.

PURPOSE: To evaluate the safety and efficacy of wrapping an ACL autograft with an amnion collagen matrix and injecting bone marrow aspirate concentrate (BMAC), quantify the cellular content of the BMAC samples, and assess 2-year postoperative patient-reported outcomes.

STUDY DESIGN: Randomized controlled trial; Level of evidence, 2.

METHODS: A total of 40 patients aged 18 to 35 years who were scheduled to undergo ACLR were enrolled in a prospective single-blinded randomized controlled trial with 2 arms based on graft type: bone-patellar tendon-bone (BTB; n = 20) or hamstring (HS; n = 20). Participants in each arm were randomized into a control group who underwent standard ACLR or an intervention group who had their grafts wrapped with an amnion collagen matrix during graft preparation, after which BMAC was injected under the wrap layers after implantation. Postoperative magnetic resonance imaging (MRI) mapping/processing yielded mean T2* relaxation time and graft volume values at 3, 6, 9, and 12 months. Participants completed the Single Assessment Numeric Evaluation Score, Knee injury and Osteoarthritis Outcome Score, and pain visual analog scale. Statistical linear mixed-effects models were used to quantify the effects over time and the differences between the control and intervention groups. Adverse events were also recorded.

RESULTS: No significant differences were found at any time point between the intervention and control groups for BTB T2* (95% CI, -1.89 to 0.63; P = .31), BTB graft volume (95% CI, -606 to 876.1; P = .71), HS T2* (95% CI, -2.17 to 0.39; P = .162), or HS graft volume (95% CI, -11,141.1 to 351.5; P = .28). No significant differences were observed between the intervention and control groups of either graft type on any patient-reported outcome measure. No adverse events were reported after a 2-year follow-up.

CONCLUSION: In this pilot study, wrapping a graft with an amnion collagen matrix and injecting BMAC appeared safe. MRI T2* values and graft volume of the augmented ACL graft were not significantly different from that of controls, suggesting that the intervention did not result in improved graft maturation.

REGISTRATION: NCT03294759 (ClinicalTrials.gov identifier).