NCT02976285

Polyester Patch in Massive Rotator Cuff Repair Improves Healing

Application of a New Polyester Patch in Arthroscopic Massive Rotator Cuff Repair Significantly Improves Clinical Outcome and Tendon Integrity

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 54 (actual)
• Sponsor: Etzel Clinic · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to assess the impact and potential advantage of a novel synthetic patch augmentation in repair of massive rotator cuff (RC) tears, using clinical and radiological approaches. The investigators hypothesized that implanting this patch will improve individual shoulder function, while reducing re-tear rates compared to the current literature.

Detailed description

To evaluate this, patches were implanted into 54 shoulders and prospectively followed up clinically and radiologically.

Conditions

• Rotator Cuff Tear

Interventions

Type	Name	Description
PROCEDURE	arthroscopic rotator cuff repair with a polyester patch	Patients were operated under general anesthesia and a supraclavicular nerve block, in a beach-chair position with 80° forward shoulder flexion and traction between 3-5 kg. After washing and draping a standard viewing portal was placed at the dorsal softspot. Further portals included, a lateral, a dorso-lateral, an antero-lateral and an anterior portal. If additional pathologies were present, they were treated simultaneously and mostly involved the long head of the biceps tendon, treated with tenodesis or tenotomy respectively. After a thorough bursectomy, the rupture was fully visualized and thereafter its size was estimated. Following debridement of the footprint, we used a triple row repair and implanted the patch.

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2016-11-29
• Last updated: 2016-11-29