Arthroscopic Rotator Cuff Repair With Synovectomy

Not Applicable

Completed

• Conditions: Rotator Cuff Tears
• Interventions: Other: Arthroscopic rotator cuff repair without synovectomy; Other: Arthroscopic rotator cuff repair with synovectomy

• Registration Number: NCT03061942
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to assess the effect of synovectomy on clinical outcomes of arthroscopic rotator cuff repair.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-23
• Study Start: 2017-03-08
• Status Verified: 2017-09
• Primary Completion: 2018-10-26
• Study Completion: 2018-10-26
• Last Update Submitted: 2018-10-29
• Last Update Posted: 2018-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with a full-thickness rotator cuff tear undergoing arthroscopic rotator cuff repair

Exclusion Criteria

• History of shoulder surgery
• Acute trauma on affected shoulder
• Chronic dislocation
• Pyogenic infection
• Rotator cuff arthropathy with glenohumeral osteoarthritis and superior migration of the humeral head
• Isolated subscapularis tear
• Psychiatric problems that precluded informed consent
• An inability to read or write
• Other serious issues that precluded participation in the study
• Open surgery
• Rotator cuff tear with worker's compensation claim
• Refuse to participate in the study
• LOM that need brisement force
• Partial-thickness tear with focal full-thickness extension
• Irrepairable rotator cuff tear
• Subjects who, for any reason, are judged by the investigator to be inappropriate for this study, including a subject who had other severe medical condition or laboratory abnormality, or who is unable to communicate or to cooperate with the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional	Arthroscopic rotator cuff repair without synovectomy	Arthroscopic rotator cuff repair without synovectomy
Synovectomy	Arthroscopic rotator cuff repair with synovectomy	Arthroscopic rotator cuff repair with synovectomy

Primary Outcome Measures

Name	Time	Method
The worst pain VAS(visual analogue scale)	at 3 months after surgery	A 10-cm scale marked from ''no pain''(0) to ''unbearable pain''(10) was used.

Secondary Outcome Measures

Name	Time	Method
The average pain VAS(visual analogue scale)	at 3 months after surgery	The average pain VAS(visual analogue scale) is the mean of the pain VAS at rest, at night, and with movement.
Constant-Murley score	at 3 months after surgery	The Constant-Murley score (CMS) is a 100-points scale composed of pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.

Trial Locations

Locations (1)

Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine; 🇰🇷 Seoul, Korea, Republic of