Superior capsular reconstruction of irreparable degenerative rotator cuff tears of the shoulder: A multicenter, comparative, prospective, observational follow-up study

Degenerative rotator cuff tears are common in the elderly and can cause serious pain and functional limitation. When conservative treatment fails, (arthroscopic) rotator cuff repair can be considered. In case of a massive rotator cuff tear, primary rotator cuff repair is not possible and a reversed shoulder prosthesis can be considered. This is an invasive surgery, with an increased risk of serious complications and no guarantee of complete recovery of function. A few years ago, a new arthroscopic technique was introduced, capable of repairing massive rotator cuff tears. This so-called superior capsular reconstruction (SCR) restores the superior capsule by suturing an ‘acellular dermal matrix’ to the glenoid and the humeral head to overcome the rotator cuff tear. This technique is joint-saving and therefore less invasive and presumably has a lower chance of complications than a reversed shoulder prosthesis. Superior capsular reconstruction could be performed with different types of allografts as ‘acellular dermal matrix’: porcine graft or human graft. For both types of allografts Tthe first results of superior capsular reconstruction are promising, although follow-up was relatively short so far. This study is set up to investigate long term effects of superior capsular reconstruction with porcine graft compared to human allograft. We hypothesize superior capsular reconstruction results in a decline of pain and restoration of function without severe complications and with no differences between the porcine and human allograft.This study aims to investigate the results of superior capsular reconstruction in terms of pain and function, and to evaluate the outcomes of porcine graft compared to human allograft in patients with an irreparable degenerative rotator cuff tear. Secondary, radiographic and MRI analyses will be performed to monitor complications. The objectives of this study are to investigate the effect of superior capsular reconstruction with porcine graft compared to human allograft in patients with an irreparable degenerative rotator cuff tear on pain and function. Secondary, complications will be monitored and radiographic and MRI analyses performed as safety measures.This study is a multicenter, comparative, prospective, longitudinal observational study. One center (VieCuri Medical Center, Venlo, The Netherlands) will perform superior capsular reconstruction with the porcine graft. The other participating center (ViaSana, Mill, The Netherlands) will perform superior capsular reconstruction with the human allograft.

Our hypothesis is that patients show an increase in the CMS that is at least as good as reported results from reversed shoulder arthroplasty. We hypothesize that the effect of this procedure will last on the long term. Furthermore, we hypothesize no differences in this effect will be found between porcine and human allograft.

Pre-operative; postoperative outpatient follow-up visits will occur at 3, and 6 months and 1, 2, 5 and 10 years

Arthroscopic superior capsular reconstruction by means of a porcine graft or human allograft.