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

Not Applicable

Active, not recruiting

• Conditions: Rotator Cuff Tear
• Interventions: Procedure: Rotator Cuff Repair without Suprascapular Nerve decompression; Procedure: Rotator Cuff Repair with Suprascapular Nerve decompression

• Registration Number: NCT02107573
• Lead Sponsor: University of Chicago

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-07-15
• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-08
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Reparable full thickness supraspinatus and or infraspinatus rotator cuff tears regardless of retraction

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Exclusion Criteria

• Patients less than 18 years of age
• Irreparable rotator cuff tears

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rotator cuff repair without Suprascapular Nerve decompression	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
Rotator Cuff Repair with Suprascapular Nerve decompression	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

Primary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeons (ASES) Shoulder Score	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

Name	Time	Method
Constant Shoulder Score	one year	It includes pain score, functional assessment, range of motion and strength measures

Trial Locations

Locations (2)

The University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Northshore University; 🇺🇸 Evanston, Illinois, United States