Arthroscopic Rotator Cuff Repair With Synovectomy

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

Official Title
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Arthroscopic Rotator Cuff Repair With Synovectomy; Prospective Randomized Controlled Study

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Other: Arthroscopic rotator cuff repair without synovectomy
* Other: Arthroscopic rotator cuff repair with synovectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional<br>Arthroscopic rotator cuff repair without synovectomy | Other: Arthroscopic rotator cuff repair without synovectomy<br>* 30 subjects will undergo conventional arthroscopic rotator cuff repair without synovectomy.<br>|
| Experimental: Synovectomy<br>Arthroscopic rotator cuff repair with synovectomy | Other: Arthroscopic rotator cuff repair with synovectomy<br>* 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.<br>|

What is the study measuring?
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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 |