Subscapularis Tears in Large to Massive Rotator Cuff Tear

NCT03352180 | Unknown

• 1 other identifier: 201608-HR091
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Do concomitant subscapularis tears in large to massive rotator cuff tears affect postoperative functional and structural outcomes? Background and purpose: The subscarpularis tendon is essential force maintaining normal glenohumeral biomechanics. However, there are few studies which have addressed the outcomes of tears extending to the subscapularis tendon in massive rotator cuff tears. The purpose of this study was to assess the clinical and structural outcomes of arthroscopic reapair of massive rotator cuff tears involving the subscapulrais.

Conditions

Massive Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale

  The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.

  4weeks

Secondary Outcomes (1)

• The American Shoulder and Elbow Surgeons Shoulder Score (ASES)

  4weeks

Study Arms (2)

subscapularis tendon repair

ACTIVE COMPARATOR

arthroscopic reapir of subscapularis tendon

Procedure: arthroscopic reapir of subscapularis tendon

subscapularis tendon debridement

ACTIVE COMPARATOR

arthroscopic debredement of subscapularis tendon

Procedure: arthroscopic debridement of subscapularis tendon

Interventions

arthroscopic reapir of subscapularis tendon PROCEDURE

arthroscopic reapir of massive rotator cuff tears involving the subscapularis.

subscapularis tendon repair

arthroscopic debridement of subscapularis tendon PROCEDURE

arthroscopic debridement of massive rotator cuff tears involving the subscapularis.

subscapularis tendon debridement

Eligibility Criteria

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

You may qualify if:

• a full-thickness superoposterior rotator cuff tear larger than 5 cm or complete superoposterior rotator cuff tear identified on preoperative MRI and intra operative arthroscopic findings
• a follow-up MRI evaluation at 6 months after surgery, and
• a clinical assessment performed a minimum 2 years postoperatively.

You may not qualify if:

• small, medium, or large tears
• a partial-thickness tear
• an isolated subscapularis tear
• failure of subscapularis repair at the time of the index procedure
• previous rotator cuff surgery of the affected shoulder
• concomitant surgery for glenohumeral joint instability or other bony procedure
• substantial glenohumeral arthritis (Hamada classification grade 4) or inflammatory arthropathy of the affected shoulder.

Sponsors & Collaborators

• Wonkwang University Hospital: lead

Study Sites (1)

Wonkwang University Hospital

Iksan, Jeollabuk-do, South Korea

RECRUITING

Central Study Contacts

Jeong Woo Kim

CONTACT

82-10-8648-7514; serina@wonkwang.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Orthopedic Surgery, Wonkwang University Hospital, Iksan, Korea Professor Jeong Woo Kim, MD

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 24, 2017
• Study Start: November 21, 2017
• Primary Completion: July 11, 2018
• Study Completion: July 11, 2019
• Last Updated: November 24, 2017

Record last verified: 2017-11

Locations

KR (1)