Arthroscopic Rotator Cuff Repair With Synovectomy

NCT ID: NCT03061942

Last Updated: 2018-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-08

Study Completion Date

2018-10-26

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.

Detailed Description

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Conditions

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Rotator Cuff Tears

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Conventional

Arthroscopic rotator cuff repair without synovectomy

Group Type ACTIVE_COMPARATOR

Arthroscopic rotator cuff repair without synovectomy

Intervention Type OTHER

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

Synovectomy

Arthroscopic rotator cuff repair with synovectomy

Group Type EXPERIMENTAL

Arthroscopic rotator cuff repair with synovectomy

Intervention Type 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.

Interventions

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Arthroscopic rotator cuff repair without synovectomy

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

Intervention Type 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.

Intervention Type OTHER

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyunchul Jo

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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BRM 17-01

Identifier Type: -

Identifier Source: org_study_id

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