A Preliminary Study of Post-Market Bridge-Enhanced ACL Restoration (BEAR) Suggests Non-Inferior Short-Term Outcomes and Low Complications.

Abstract

Background: To improve outcomes following anterior cruciate ligament (ACL) reconstruction, bridge-enhanced ACL restoration (BEAR) was introduced. Bridge-enhanced ACL restoration uses a collagen-based implant saturated with infused autologous blood to bridge the torn proximal and distal ACL fibers.

Purpose: We sought to analyze the short-term complications, clinical outcomes, and patient-reported outcome measures (PROMs) in patients undergoing BEAR outside of the initial clinical trials.

Methods: We conducted a retrospective cohort study of all skeletally mature patients who had a midsubstance or proximal ACL tear treated with BEAR by 2 surgeons at a single institution and had a minimum follow-up of 6 weeks. A total of 58 patients were included (average age was 38 years, average time from injury to surgery was 45 days). Data on demographic factors, functional outcomes, and complications were collected from electronic medical records. Patient-reported outcome measures and a descriptive return-to-activity survey were analyzed utilizing paired t-tests and Wilcoxon signed-rank tests.

Results: All 58 patients demonstrated a grade of 1A on the Lachman test at 6 weeks postoperatively. At 6 months postoperatively, the mean active flexion was 135° ± 5°, and all patients achieved 0° extension. Although not all patients completed PROM questionnaires, among those who did we observed a significant increase in PROMs between preoperative and postoperative measurements; more than half achieved the minimal clinically important difference in all PROMs, and 26 patients (87%) had a 1-level decrease in function. There were no cases of retear or instability. Three patients (5%) had postoperative arthrofibrosis.

Conclusion: Early results of this preliminary post-market approval study suggest that BEAR may provide a safe and non-inferior approach to ACL reconstruction in selected patients. Studies are needed to investigate the long-term outcomes of this novel technique.