Biodegradable subacromial spacer insertion for rotator cuff tears

NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 9 sources, which was discussed by the committee. The evidence included 2 randomised controlled trials (RCTs), 2 systematic reviews, 1 case-control study, 1 retrospective comparative study and 3 case series. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.

The professional experts and the committee considered the key efficacy outcomes to be: improvement in shoulder function, reduction in pain and patient-reported outcomes.

The professional experts and the committee considered the key safety outcomes to be: pain, bleeding, infection and reduction in the range of shoulder motion.

Patient commentary was sought but none was received.

The committee noted that there was strong evidence from a UK-based, group-sequential, double-blind multicentre RCT. It found that debridement with spacer insertion was inferior to debridement alone, and did not improve the primary outcome of Oxford Shoulder Score at 12 months. The study was stopped early because of futility. The result of this study was the main factor in the committee's decision to recommend that the procedure should not be used when debridement is a suitable option. The committee also understood that there is some uncertainty among experts about the benefit of debridement compared with non-surgical care.

The committee noted that another RCT showed non-inferiority of the procedure compared with partial rotator cuff repair. It concluded that more research is needed to address the uncertainties about the long-term safety and efficacy of the procedure.

The committee was informed that this procedure should not be used in people with a missing or non-intact coracoacromial ligament.