OBJECTIVES

Rotator cuff injuries are a leading cause of shoulder dysfunction, where bio-inductive collagen implants have demonstrated promising results in promoting tendon regeneration and reducing retear rates. However, existing evidence lacks consistent evaluation across varying follow-up durations, while the specific factors influencing their safety and effectiveness remain undetermined. This study aims to evaluate the quality of evidence regarding the safety, efficacy, and impact factors of applying the resorbable bio-inductive collagen implant clinically to repair rotator cuff injuries.

METHODS

The study protocol was registered on PROSPERO (CRD42022367522). A systematic literature search of PubMed, Web of Science, Embase, and Cochrane Library (from inception to October 2024) for clinical studies on bio-inductive collagen implants for rotator cuff repair. Two investigators independently screened studies, extracted data, and assessed quality (using RoB1 for RCTs, NOS for cohort studies and JBI critical appraisal tools for case series). Primary outcomes included postoperative tendon thickness, shoulder function scores (ASES/Constant), and re-tear rates. Data were analyzed using random/fixed-effects models to calculate mean differences (MDs) with 95% CIs, with subgroup analyses for tear type, patient age, and postoperative mobilization time. Statistical analyses were performed using Stata 17.0.

RESULTS

Seventeen studies were included. The meta-analysis results showed that postoperative tendon thickness of the patients increased statistically compared with the baseline, at 3 months (MD = 2.22; 95% CI: 1.61, 2.83; p < 0.001), 6 months (MD = 2.30; 95% CI: 1.44, 3.16; p < 0.001), 12 months (MD = 2.15; 95% CI: 1.58, 2.72; p < 0.001), and 24 months (MD = 1.05; 95% CI: 0.02, 2.08; p = 0.045). Postoperative shoulder joint function improved significantly. The ASES score and Constant score of the patients were significantly higher than the baseline at 6 months (ASES: MD = 35.90; 95% CI: 32.97, 38.83; p < 0.001), 12 months (ASES: MD = 40.83; 95% CI: 37.56, 44.10; p < 0.001; Constant: MD = 28.59; 95% CI: 21.44, 35.74; p < 0.001), and 24 months (ASES: MD = 39.80; 95% CI: 31.32, 48.27; p < 0.001; Constant: MD = 32.84; 95% CI: 28.72, 36.97; p < 0.001).

CONCLUSION

The bio-inductive collagen implant is effective and safe for healing rotator cuff injuries. Patient age may be an important moderator affecting its efficacy. The impact of tear size and postoperative activities on efficacy needs to be further explored through in-depth clinical studies.