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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02107573
Recruitment Status : Active, not recruiting
First Posted : April 8, 2014
Last Update Posted : May 6, 2023
Sponsor:
Collaborator:
NorthShore University HealthSystem
Information provided by (Responsible Party):
University of Chicago

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Procedure: Rotator Cuff Repair without Suprascapular Nerve decompression Procedure: Rotator Cuff Repair with Suprascapular Nerve decompression Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Will Routine Suprascapular Nerve Release During Arthroscopic Rotator Cuff Repair Improve Patient Outcomes?
Actual Study Start Date : July 15, 2013
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Rotator cuff repair without Suprascapular Nerve decompression
approximately 17 subjects in the study will receive traditional rotator cuff repair surgical intervention with no suprascapular nerve decompression surgical intervention
 Procedure: Rotator Cuff Repair without Suprascapular Nerve decompression
Traditional rotator cuff repair without Suprascapular nerve decompression
Active Comparator: Rotator Cuff Repair with Suprascapular Nerve decompression
approximately 17 subjects in the study will undergo rotator cuff repair with arthroscopic suprascapular nerve decompression surgical intervention
 Procedure: Rotator Cuff Repair with Suprascapular Nerve decompression
Traditional rotator cuff repair with Suprascapular nerve decompression


Outcome Measures
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Primary Outcome Measures :
  1. American Shoulder and Elbow Surgeons (ASES) Shoulder Score [ Time Frame: one year ]
    The scale measures pain from 0 to 10 and also includes a questionnaire for assessing the activity of daily living.


Secondary Outcome Measures :
  1. Constant Shoulder Score [ Time Frame: one year ]
    It includes pain score, functional assessment, range of motion and strength measures


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107573


Locations
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United States, Illinois
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Northshore University
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
University of Chicago
NorthShore University HealthSystem
Investigators
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Principal Investigator: Lewis L Shi, MD University of Chicago
Principal Investigator: Jason Koh, MD Northshore University
More Information
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02107573    
Other Study ID Numbers: IRB13-0099
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Chicago:
Randomized Controlled Trial
Rotator Cuff Tear
Suprascapular Nerve
Decompression
Shoulder Surgery
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries