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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02976285
Enrollment
54
Registered
2016-11-29
Start date
2012-06-30
Completion date
2015-08-31
Last updated
2016-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tear

Keywords

arthroscopic rotator cuff repair, patch augmentation

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.

Interventions

PROCEDUREarthroscopic 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.

Sponsors

Etzel Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Function assessed with the Constant-Murley-Score25 months
Function assessed with the Subjective Shoulder Value25 months

Secondary

MeasureTime frame
Tendon integrity evaluated radiologically1-35 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026