Arthroscopic Rotator Cuff Repair With Synovectomy

Rotator Cuff Tears Clinical Trial

Official title:

Arthroscopic Rotator Cuff Repair With Synovectomy; Prospective Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03061942
• Other study ID #: BRM 17-01
• Status: Completed
• Phase: N/A
• Start date: March 8, 2017
• Est. completion date: October 26, 2018

Study information

• Verified date: September 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 26, 2018
• Est. primary completion date: October 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Other:
• Arthroscopic rotator cuff repair without synovectomy
30 subjects will undergo conventional arthroscopic rotator cuff repair without synovectomy.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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