Arthroscopic Rotator Cuff Repair With Synovectomy

NCT03061942 | Completed

• 1 other identifier: BRM 17-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• The worst pain VAS(visual analogue scale)

  A 10-cm scale marked from ''no pain''(0) to ''unbearable pain''(10) was used.

  at 3 months after surgery

Secondary Outcomes (2)

• Constant-Murley score

  at 3 months after surgery

• The average pain VAS(visual analogue scale)

  at 3 months after surgery

Study Arms (2)

Conventional

ACTIVE COMPARATOR

Arthroscopic rotator cuff repair without synovectomy

Other: Arthroscopic rotator cuff repair without synovectomy

Synovectomy

EXPERIMENTAL

Arthroscopic rotator cuff repair with synovectomy

Other: Arthroscopic rotator cuff repair with synovectomy

Interventions

Arthroscopic rotator cuff repair without synovectomy OTHER

30 subjects will undergo conventional arthroscopic rotator cuff repair without synovectomy.

Conventional

Arthroscopic rotator cuff repair with synovectomy OTHER

30 subjects will undergo arthroscopic rotator cuff repair with synovectomy. Synovectomy is an operation performed to remove inflamed synovial membrane of a joint. Arthroscopic synovectomy will be performed with the use of a shaver and a cautery device through the portals for arthroscopic rotator cuff repair.

Synovectomy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Synovectomy

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: February 23, 2017
• Study Start: March 8, 2017
• Primary Completion: October 26, 2018
• Study Completion: October 26, 2018
• Last Updated: October 31, 2018

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)