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Clinical Trials/NCT03183466
NCT03183466
Unknown
Not Applicable

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)

Samsung Medical Center1 site in 1 country80 target enrollmentDecember 1, 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Subscapularis Tendon Tear
Sponsor
Samsung Medical Center
Enrollment
80
Locations
1
Primary Endpoint
American Shoulder and Elbow Surgeons' score
Last Updated
8 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2011
End Date
July 1, 2017
Last Updated
8 years ago
Study Type
Interventional
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

American Shoulder and Elbow Surgeons' score

Time Frame: 2 year postoperatively

Constant score

Time Frame: 2 year postoperatively

Korean Shoulder Score (KSS) score

Time Frame: 2 year postoperatively

Range of Motion (ROM)

Time Frame: 2 year postoperatively

Pain Visual Analogue Scale (PVAS)

Time Frame: 2 year postoperatively

Secondary Outcomes

  • repair integrity analysis using postoperative MRI(6 months)

Study Sites (1)

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