Non-surgical treatment of anterior cruciate ligament tears with percutaneous bone marrow concentrate and platelet products versus exercise therapy: a randomized-controlled, crossover trial with 2-year follow-up.

BACKGROUND: Anterior cruciate ligament (ACL) reconstruction (ACLR) surgery remains the prevailing standard of care for complete ACL ruptures but is not without risk. The aim of this study was to compare non-surgical, autologous bone marrow concentrate (BMC) with platelet products compared to exercise therapy for partial and complete, non-retracted ACL tears without meniscus injuries. METHODS: In this randomized-controlled, crossover trial, patients received either exercise therapy or an injection of BMC with platelet products to treat ACL tears. After 3 months, if patients randomized to the exercise group were not satisfied with their improvement, they could crossover to receive the BMC treatment. Patients reported outcomes were completed at pre-treatment, 1-, 3, 6-, 12-, and 24-months of the Numeric Pain Scale (NPS), the International Knee Documentation Committee (IKDC) subjective knee form, Lower Extremity Function Scale (LEFS), and a modified Single Assessment Numeric Evaluation (SANE). MRIs at pre- and post-treatment were assessed using ImageJ software analysis. Complications and surgeries were assessed at each time point. RESULTS: Patients in the BMC group reported significantly greater change scores (from pre-treatment) on LEFS (P = 0.027), and SANE (P = 0.007) at 3 months compared to the exercise group. No significant differences were found between baseline and/or 1- month and 3-month follow-ups for any outcome measure (P > 0.05) in the exercise therapy group. When followed through 2 years, patients who received BMC treatment demonstrated sustained improvements in function and decreases in pain, with patients reporting a median of subjective improvement (SANE) of 90% at the final follow-up. Significant negative correlations were found between age of injury and ΔIKDC ΔLEFS, and SANE (P < 0.05) at the 24-month follow-up with lower ΔPROMs reported by those with older tears the age of tear (> 12 months). Post-treatment MRI provided evidence of significant improvements in ACL integrity. No serious adverse events were reported. Four patients did not respond to BMC treatment and underwent ACL reconstruction without any new reports of knee injuries. CONCLUSIONS: The significant improvements in function, pain, and overall improvement in patients receiving BMC and platelets provide evidence of a viable alternative treatment option for patients with ACL tears. TRIAL REGISTRATION: NCT01850758; A Randomized Controlled Trial of Regenexx-SD Versus Exercise therapy for Treatment of Partial and Complete, Non-retracted Anterior Cruciate Ligament Tears. Registered May 7, 2013.