Polyester Patch in Massive Rotator Cuff Repair Improves Healing

November 23, 2016 updated by: Etzel Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

54

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

54 patients (38 male / 16 female) 54 shoulders (29 right / 25 left) Mean patient age at the time of surgery was 65 years (range 41 - 75).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Function assessed with the Constant-Murley-Score
Time Frame: 25 months
25 months
Function assessed with the Subjective Shoulder Value
Time Frame: 25 months
25 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Tendon integrity evaluated radiologically
Time Frame: 1-35 months
1-35 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Etzel Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

November 15, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (Estimate)

November 29, 2016

Study Record Updates

Last Update Posted (Estimate)

November 29, 2016

Last Update Submitted That Met QC Criteria

November 23, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PitchPatch54

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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