Comparing the Outcomes Between Rotator Cuff Repair With and Without Suprascapular Nerve Decompression
Primary Purpose
Rotator Cuff Tear
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rotator Cuff Repair without Suprascapular Nerve decompression
Rotator Cuff Repair with Suprascapular Nerve decompression
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Randomized Controlled Trial, Rotator Cuff Tear, Suprascapular Nerve, Decompression, Shoulder Surgery
Eligibility Criteria
Inclusion Criteria:
- Reparable full thickness supraspinatus and or infraspinatus rotator cuff tears regardless of retraction
Exclusion Criteria:
- Patients less than 18 years of age
- Irreparable rotator cuff tears
Sites / Locations
- The University of Chicago Medical Center
- Northshore University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Rotator cuff repair without Suprascapular Nerve decompression
Rotator Cuff Repair with Suprascapular Nerve decompression
Arm Description
approximately 17 subjects in the study will receive traditional rotator cuff repair surgical intervention with no suprascapular nerve decompression surgical intervention
approximately 17 subjects in the study will undergo rotator cuff repair with arthroscopic suprascapular nerve decompression surgical intervention
Outcomes
Primary Outcome Measures
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
The scale measures pain from 0 to 10 and also includes a questionnaire for assessing the activity of daily living.
Secondary Outcome Measures
Constant Shoulder Score
It includes pain score, functional assessment, range of motion and strength measures
Full Information
NCT ID
NCT02107573
First Posted
April 4, 2014
Last Updated
May 3, 2023
Sponsor
University of Chicago
Collaborators
NorthShore University HealthSystem
1. Study Identification
Unique Protocol Identification Number
NCT02107573
Brief Title
Comparing the Outcomes Between Rotator Cuff Repair With and Without Suprascapular Nerve Decompression
Official Title
Will Routine Suprascapular Nerve Release During Arthroscopic Rotator Cuff Repair Improve Patient Outcomes?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 15, 2013 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
NorthShore University HealthSystem
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to compare the differences in outcome between the traditional rotator cuff repair surgery and rotator cuff repair with suprascapular nerve decompression surgery.
Detailed Description
The suprascapular nerve is intimately related to the function and likely recovery of the rotator cuff musculature. Retracted rotator cuff tears have recently been shown to effect both the physical path in which the suprascapular nerve travels, as well as its physiologic function.
This study will be a randomized control trial with long term follow up that will add to and elaborate on the positive outcomes reported in other trials. Patients that have a rotator cuff tears with greater than or equal to 1 cm of retraction that have failed conservative treatment and require operative repair will qualify for the study. They will be randomized into two arms: In one arm, patients will undergo suprascapular nerve release immediately after their rotator cuff repair; they will be compared to patients that have rotator cuff repair with no release of the nerve. Post operatively, at different time intervals, patients will be expected to fill out multiple standardized, well established surveys that assess the patients pain level and shoulder function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
Randomized Controlled Trial, Rotator Cuff Tear, Suprascapular Nerve, Decompression, Shoulder Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rotator cuff repair without Suprascapular Nerve decompression
Arm Type
Active Comparator
Arm Description
approximately 17 subjects in the study will receive traditional rotator cuff repair surgical intervention with no suprascapular nerve decompression surgical intervention
Arm Title
Rotator Cuff Repair with Suprascapular Nerve decompression
Arm Type
Active Comparator
Arm Description
approximately 17 subjects in the study will undergo rotator cuff repair with arthroscopic suprascapular nerve decompression surgical intervention
Intervention Type
Procedure
Intervention Name(s)
Rotator Cuff Repair without Suprascapular Nerve decompression
Intervention Description
Traditional rotator cuff repair without Suprascapular nerve decompression
Intervention Type
Procedure
Intervention Name(s)
Rotator Cuff Repair with Suprascapular Nerve decompression
Intervention Description
Traditional rotator cuff repair with Suprascapular nerve decompression
Primary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeons (ASES) Shoulder Score
Description
The scale measures pain from 0 to 10 and also includes a questionnaire for assessing the activity of daily living.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Constant Shoulder Score
Description
It includes pain score, functional assessment, range of motion and strength measures
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Reparable full thickness supraspinatus and or infraspinatus rotator cuff tears regardless of retraction
Exclusion Criteria:
Patients less than 18 years of age
Irreparable rotator cuff tears
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lewis L Shi, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jason Koh, MD
Organizational Affiliation
Northshore University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Northshore University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparing the Outcomes Between Rotator Cuff Repair With and Without Suprascapular Nerve Decompression
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