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

NCT ID: NCT02107573

Last Updated: 2025-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-15

Study Completion Date

2024-12-01

Brief Summary

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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

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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.

Conditions

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Rotator Cuff Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Rotator Cuff Repair without Suprascapular Nerve decompression

Intervention Type PROCEDURE

Traditional rotator cuff repair without 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

Group Type ACTIVE_COMPARATOR

Rotator Cuff Repair with Suprascapular Nerve decompression

Intervention Type PROCEDURE

Traditional rotator cuff repair with Suprascapular nerve decompression

Interventions

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Rotator Cuff Repair without Suprascapular Nerve decompression

Traditional rotator cuff repair without Suprascapular nerve decompression

Intervention Type PROCEDURE

Rotator Cuff Repair with Suprascapular Nerve decompression

Traditional rotator cuff repair with Suprascapular nerve decompression

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Endeavor Health

OTHER

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lewis L Shi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Jason Koh, MD

Role: PRINCIPAL_INVESTIGATOR

Northshore University

Locations

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The University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Northshore University

Evanston, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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IRB13-0099

Identifier Type: -

Identifier Source: org_study_id

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