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Arthroscopic Rotator Cuff Repair With Synovectomy

Primary Purpose

Rotator Cuff Tears

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Arthroscopic rotator cuff repair without synovectomy
Arthroscopic rotator cuff repair with synovectomy
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional

Synovectomy

Arm Description

Arthroscopic rotator cuff repair without synovectomy

Arthroscopic rotator cuff repair with synovectomy

Outcomes

Primary Outcome Measures

The worst pain VAS(visual analogue scale)
A 10-cm scale marked from ''no pain''(0) to ''unbearable pain''(10) was used.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 20, 2017
Last Updated
October 29, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03061942
Brief Title
Arthroscopic Rotator Cuff Repair With Synovectomy
Official Title
Arthroscopic Rotator Cuff Repair With Synovectomy; Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 8, 2017 (Actual)
Primary Completion Date
October 26, 2018 (Actual)
Study Completion Date
October 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
Arthroscopic rotator cuff repair without synovectomy
Arm Title
Synovectomy
Arm Type
Experimental
Arm Description
Arthroscopic rotator cuff repair with synovectomy
Intervention Type
Other
Intervention Name(s)
Arthroscopic rotator cuff repair without synovectomy
Intervention Description
30 subjects will undergo conventional arthroscopic rotator cuff repair without synovectomy.
Intervention Type
Other
Intervention Name(s)
Arthroscopic rotator cuff repair with synovectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The worst pain VAS(visual analogue scale)
Description
A 10-cm scale marked from ''no pain''(0) to ''unbearable pain''(10) was used.
Time Frame
at 3 months after surgery
Secondary Outcome Measure Information:
Title
Constant-Murley score
Description
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.
Time Frame
at 3 months after surgery
Title
The average pain VAS(visual analogue scale)
Description
The average pain VAS(visual analogue scale) is the mean of the pain VAS at rest, at night, and with movement.
Time Frame
at 3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Arthroscopic Rotator Cuff Repair With Synovectomy

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