Bioinductive Collagen Implant Has Potential to Improve Rotator Cuff Healing: A Systematic Review.

PURPOSE

To systematically review the literature to evaluate the clinical studies on bioinductive collagen implant (BCI) for the treatment of rotator cuff tears.

METHODS

A literature search of MEDLINE, Embase, and the Cochrane Library was performed based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Clinical studies reporting BCI for rotator cuff tears were included. Quantitive and qualitative data were evaluated.

RESULTS

A total of 21 studies were included. In patients with full-thickness tears, 7 of the 8 studies with pre- to postoperative American Shoulder and Elbow Surgeons (ASES) scores demonstrated statistically significant improvements in mean pre- to postoperative ASES scores, with 75% to 100% of patients meeting the minimal clinically important difference. In those with partial-thickness tears, 7 of the 8 studies with pre- to postoperative ASES scores demonstrated statistically significant improvements in mean pre- to postoperative ASES scores, with 54.4% to 100% of patients meeting the minimal clinically important difference. For studies that quantified percent increases in tendon thickness, the reported increases ranged from 13% to 44% in full-thickness tears and 14% to 60% in partial-thickness tears. Six studies evaluated rotator cuff retears after BCI treatment in the full-thickness cohort, with rates reported ranging from 0% to 9%. Five studies evaluated rotator cuff retears after BCI treatment in the partial-thickness cohort, with rates reported ranging from 0% to 18%. Two of the included studies found that BCI was cost-effective due to the increased tendon healing, with cost savings of $5,338 to $13,061 per healed rotator cuff tendon.

CONCLUSIONS

The literature on rotator cuff tear augmentation with BCI has shown consistently reported good results. Additionally, there was evidence of low retear rates and consistently improved tendon thickness with BCI, with 2 randomized controlled trials showing improved tendon healing with BCI. However, there appears to be a higher rate of adhesive capsulitis reported.

LEVEL OF EVIDENCE

Level IV, systematic review of Level I, III, and IV studies.