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

NCT03183466 | Unknown

• 1 other identifier: 2011-11-029-025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Subscapularis Tendon Tear; Arthroscopic Repair; Arthroscopic Debridement

Outcome Measures

Primary Outcomes (5)

• Range of Motion (ROM)

  2 year postoperatively

• Pain Visual Analogue Scale (PVAS)

  2 year postoperatively

• American Shoulder and Elbow Surgeons' score

  2 year postoperatively

• Constant score

  2 year postoperatively

• Korean Shoulder Score (KSS) score

  2 year postoperatively

Secondary Outcomes (1)

• repair integrity analysis using postoperative MRI

  6 months

Study Arms (1)

Patients included in inclusion criteria

EXPERIMENTAL

Procedure: arthroscopic repair; Procedure: arthroscopic debridement

Interventions

arthroscopic repair PROCEDURE

Patients included in inclusion criteria

arthroscopic debridement PROCEDURE

Patients included in inclusion criteria

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (4)

• Burkhart SS, Tehrany AM. Arthroscopic subscapularis tendon repair: Technique and preliminary results. Arthroscopy. 2002 May-Jun;18(5):454-63. doi: 10.1053/jars.2002.30648.

  PMID: 11987054 BACKGROUND

• Denard PJ, Jiwani AZ, Ladermann A, Burkhart SS. Long-term outcome of a consecutive series of subscapularis tendon tears repaired arthroscopically. Arthroscopy. 2012 Nov;28(11):1587-91. doi: 10.1016/j.arthro.2012.02.031. Epub 2012 May 24.

  PMID: 22632896 BACKGROUND

• Flury MP, John M, Goldhahn J, Schwyzer HK, Simmen BR. Rupture of the subscapularis tendon (isolated or in combination with supraspinatus tear): when is a repair indicated? J Shoulder Elbow Surg. 2006 Nov-Dec;15(6):659-64. doi: 10.1016/j.jse.2005.07.013. Epub 2006 Oct 19.

  PMID: 17055750 BACKGROUND

• Jeong JY, Kim SC, Lee SM, Yoo JC. Prospective Randomized Clinical Trial of Arthroscopic Repair Versus Debridement for Partial Subscapularis Tendon Tears More Than Half of the Entire First Facet. Am J Sports Med. 2023 Sep;51(11):2804-2814. doi: 10.1177/03635465231187033. Epub 2023 Aug 7.

  PMID: 37548022 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 12, 2017
• Study Start: December 1, 2011
• Primary Completion: November 30, 2014
• Study Completion: July 1, 2017
• Last Updated: June 12, 2017

Record last verified: 2017-05

Locations

KR (1)