**6. Leeds Cuff Patch**

Our technique of choice in surgical treatment of irreparable rotator cuff tear was developed by the senior author. We utilize a non-absorbable polyester patch which is sutured over the torn rotator cuff. It thus provides reinforcement of incompletely repaired rotator cuff tears and those at high risk of re-tear due to poor quality soft tissue. It can be used both as a bridging graft and augmentation. Leeds Cuff Patch a synthetic patch that is indicated for reconstruction of chronic massive, full thickness rotator cuff tears where the retracted tear cannot be mobilized back to the bony attachment site or where the cuff tissue has undergone degeneration. The patch implant is produced from polyethylene terephthalate (PET), commonly known as polyester. This is a non-absorbable biocompatible material that has been in use for the reconstruction of ligaments and tendons for over 25 years. The design of the patch comprises a base component with an integral reinforcement component. The base component has a 'open structure' that acts as a scaffold allowing tissue ingrowth. The reinforcement provides enhanced strength to the patch. The patch can be implanted with typical techniques and sutures as used for other tendon augmentation xenograft and allograft patches. The weak point of a repair with such products is between the suture and tendon. However, the integral reinforcement of the patch provides resistance to suture pull-through and thus addresses this common failure mode for such devices.

Conducting our own research, we compared outcomes of the Leeds Cuff Patch with other treatment interventions available (e.g. anterior deltoid rehabilitation exercises, arthroscopic rotator cuff repair, arthroscopic rotator cuff debridement) for patients with large or massive cuff tears.

We recruited 68 patients with large and massive rotator cuff tears: 29 in the Patch group and 39 as controls. The treatment decision was made based on patient choice and intra-operative findings: those patients who wished to avoid operative intervention underwent anterior deltoid rehabilitation; those with arthroscopically reparable tears received that treatment; those with arthroscopically irreparable tears but mobile cuff underwent open patch repair; those with substantial retraction of poor quality immobile tendon underwent debridement. All patients completed Oxford Shoulder Score (OSS), Shoulder Pain and Disability Index (SPADI), and Constant score at baseline, 6 weeks and 6 months following treatment.

The Patch group demonstrated improvement in all outcomes from baseline to 6 months (paired mean difference OSS 12.3, SPADI 18.8, Constant 13.9), as did the Control group (paired mean difference OSS 8.7, SPADI 18.8, Constant 11.1). When the patients with very poor quality rotator cuff were removed, the results were OSS 14.3 SPADI Constant 18.0. The arthroscopically repaired group showed very similar results to the remainder of the controls. Those with better quality tendon but still non-repairable had a clinically significant improvement in OSS compared with the non-patch group.

We are extending the follow-up period for this study to 2 years, and will also analyse MRI scans performed at baseline, 6 months and 2 years following surgery. This will provide both clinical and radiological outcomes of patch repair of large and massive rotator cuff tears, and be one of the first studies comparing patches with other treatment options for this group of patients.
