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NCT02107573 Clinical Trial

Comparing the Outcomes Between Rotator Cuff Repair With and Without Suprascapular Nerve Decompression

Rotator Cuff Tear Clinical Trial

Official title:
Will Routine Suprascapular Nerve Release During Arthroscopic Rotator Cuff Repair Improve Patient Outcomes?

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02107573
Other study ID # IRB13-0099
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 15, 2013
Est. completion date June 2024

Study information
Verified date May 2023
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 36
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Rotator Cuff Repair without Suprascapular Nerve decompression
Traditional rotator cuff repair without Suprascapular nerve decompression
• Rotator Cuff Repair with Suprascapular Nerve decompression
Traditional rotator cuff repair with Suprascapular nerve decompression

Locations
Country Name City State
United States The University of Chicago Medical Center Chicago Illinois
United States Northshore University Evanston Illinois

Sponsors (2)
Lead Sponsor Collaborator
University of Chicago NorthShore University HealthSystem

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. one year
Secondary Constant Shoulder Score It includes pain score, functional assessment, range of motion and strength measures one year
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