Polyester Patch in Massive Rotator Cuff Repair Improves Healing

Completed

• Conditions: Rotator Cuff Tear

• Registration Number: NCT02976285
• Lead Sponsor: Etzel Clinic

Brief 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.

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-11
• Study First Submitted: 2016-11-15
• Study First Submitted QC: 2016-11-23
• Last Update Submitted: 2016-11-23
• Study First Posted: 2016-11-29
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Inclusion criteria were age greater 18 years and a RC tear involving at least two tendons, presenting a massive RC-tear as described by Gerber et al.

Exclusion Criteria

• We excluded patients older than 75, fatty infiltration grade 4 according to Goutallier, re-ruptures of former repairs and cases with severe osteoarthritis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Function assessed with the Constant-Murley-Score	25 months
Function assessed with the Subjective Shoulder Value	25 months

Secondary Outcome Measures

Name	Time	Method
Tendon integrity evaluated radiologically	1-35 months