Do You Arthroscopic Repair for Subscapularis Tendon Tear, Which Accounts for More Than Half of the 1st Facet? Or do You Perform Debridement?

June 8, 2017 updated by: Samsung Medical Center

Prospective Randomized Clinical Trial of Arthroscopic Repair Versus Debridement for Subscapularis Tendon Tear More Than 1/2 to Entire 1st Facet (Representing 1/3 to More Than 1/3 Tear of Subscapularis Entire Footprint)

The purpose of this study was to randomly classify the upper third of the subscapularis in 1/2 of the rupture patients as preoperative group (arthroscopic and arthroscopic debridement group) and the difference between clinical and clinical scores.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The degree of rupture that is an adaptation of arthroscopic surgery is now known to be about one-third to one-half of a rupture. However, the most controversial case is the one-third to one-half of the upper tear attached to the tendinous portion of the subscapularis. Currently, debridement or repair is under way. But evidence-based studies are lacking and no clear treatment guidelines are available.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subscapularis tendon tear from more than 1/2 to entire of 1st facet found during routine arthroscopy with 70 degree scope
  • Isolated or combined with Supraspinatus and/or Infraspinatus tear (SS/IS tear less than 3 cm)
  • Combined biceps lesion
  • Combined acromial clavicle (AC) arthritis

Exclusion Criteria:

  • Revision case or previous surgical history of the index shoulder
  • Any open surgery, including open repair of the subscapularis tendon
  • Compensation case
  • Combined severe arthritis of the glenohumeral joint
  • Patient who selects one's own surgical method, i.e. not randomized
  • Infection, tumor, etc

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

  • Primary Purpose: Treatment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients included in inclusion criteria
Procedure: arthroscopic debridement
Procedure: arthroscopic repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Range of Motion (ROM)
Time Frame: 2 year postoperatively
2 year postoperatively
Pain Visual Analogue Scale (PVAS)
Time Frame: 2 year postoperatively
2 year postoperatively
American Shoulder and Elbow Surgeons' score
Time Frame: 2 year postoperatively
2 year postoperatively
Constant score
Time Frame: 2 year postoperatively
2 year postoperatively
Korean Shoulder Score (KSS) score
Time Frame: 2 year postoperatively
2 year postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
repair integrity analysis using postoperative MRI
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

December 1, 2011

Primary Completion (Actual)

November 30, 2014

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

May 30, 2017

First Submitted That Met QC Criteria

June 8, 2017

First Posted (Actual)

June 12, 2017

Study Record Updates

Last Update Posted (Actual)

June 12, 2017

Last Update Submitted That Met QC Criteria

June 8, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2011-11-029-025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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