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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

Tracking Information
First Submitted Date  ICMJE April 4, 2014
First Posted Date  ICMJE April 8, 2014
Last Update Posted Date May 6, 2023
Actual Study Start Date  ICMJE July 15, 2013
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2014)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2014)		 Constant Shoulder Score [ Time Frame: one year ]
It includes pain score, functional assessment, range of motion and strength measures
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing the Outcomes Between Rotator Cuff Repair With and Without Suprascapular Nerve Decompression
Official Title  ICMJE Will Routine Suprascapular Nerve Release During Arthroscopic Rotator Cuff Repair Improve Patient Outcomes?
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Rotator Cuff Tear
Intervention  ICMJE
  • Procedure: Rotator Cuff Repair without Suprascapular Nerve decompression
    Traditional rotator cuff repair without Suprascapular nerve decompression
  • Procedure: Rotator Cuff Repair with Suprascapular Nerve decompression
    Traditional rotator cuff repair with Suprascapular nerve decompression
Study Arms  ICMJE
  • 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
    Intervention: Procedure: 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
    Intervention: Procedure: Rotator Cuff Repair with Suprascapular Nerve decompression
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 3, 2023)		 36
Original Estimated Enrollment  ICMJE
 (submitted: April 7, 2014)		 35
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02107573
Other Study ID Numbers  ICMJE IRB13-0099
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Chicago
Original Responsible Party Lewis Shi, University of Chicago, Medical Doctor
Current Study Sponsor  ICMJE University of Chicago
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE NorthShore University HealthSystem
Investigators  ICMJE
Principal Investigator: Lewis L Shi, MD University of Chicago
Principal Investigator: Jason Koh, MD Northshore University
PRS Account University of Chicago
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP