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Comparison of Arthroscopic Supraspinatus Tendon Tear Repair in Patients Over 60 Years With and Without Patch Augmentation.

NCT03511547 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-10-22

No results posted yet for this study

Summary

The aim of the study is to show that patch augmentation in rotatorcuff tear results in lower rate of recurrent tendon defects compared without patches.

Conditions

  • Rotator Cuff Tears

Interventions

DEVICE

Pitch Patch

The patients will be operated by shoulder arthroscopy according to the internationally standardized procedure. Patients allocated this group will receive a synthetic (Pitch-Patch™ \[PP\]) augmentation.

DEVICE

ArthroFlex

The patients will be operated by shoulder arthroscopy according to the internationally standardized procedure. Patients allocated this group will receive a biologic patch (ArthroFlex® \[AF\]) augmentation.

Sponsors & Collaborators

  • Schulthess Klinik

    lead OTHER

Principal Investigators

  • Markus Scheibel, Prof · Schulthess Klinik

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2021-01-01
Completion
2021-01-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03511547 on ClinicalTrials.gov