Arthroscopic Rotator Cuff Repair With Synovectomy

Arthroscopic Rotator Cuff Repair With Synovectomy; Prospective Randomized Controlled Study

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

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Other: Arthroscopic rotator cuff repair without synovectomy; Other: Arthroscopic rotator cuff repair with synovectomy

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional; Arthroscopic rotator cuff repair without synovectomy	Other: Arthroscopic rotator cuff repair without synovectomy; 30 subjects will undergo conventional arthroscopic rotator cuff repair without synovectomy.
Experimental: Synovectomy; Arthroscopic rotator cuff repair with synovectomy	Other: Arthroscopic rotator cuff repair with synovectomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant-Murley score	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.	at 3 months after surgery
The average pain VAS(visual analogue scale)	The average pain VAS(visual analogue scale) is the mean of the pain VAS at rest, at night, and with movement.	at 3 months after surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2017
• Primary Completion (Actual): October 26, 2018
• Study Completion (Actual): October 26, 2018

Study Registration Dates

• First Submitted: February 20, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 29, 2018
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: BRM 17-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No