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Completed

NCT Number: NCT02976285

Polyester Patch in Massive Rotator Cuff Repair Improves Healing

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.

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Key information

Conditions

Rotator Cuff Tear Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

arthroscopic rotator cuff repair with a polyester patch

Procedure

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.

Primary outcomes

  1. Function assessed with the Constant-Murley-Score

    Time frame: 25 months

  2. Function assessed with the Subjective Shoulder Value

    Time frame: 25 months

Secondary outcomes

  1. Tendon integrity evaluated radiologically

    Time frame: 1-35 months

Sponsors and collaborators

Lead sponsor

Etzel Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 29, 2016
Registry last updated
Nov 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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