Back to results

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

Primary Purpose

Rotator Cuff Tear

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Rotator Cuff Repair without Suprascapular Nerve decompression

Rotator Cuff Repair with Suprascapular Nerve decompression

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Randomized Controlled Trial, Rotator Cuff Tear, Suprascapular Nerve, Decompression, Shoulder Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The University of Chicago Medical Center
Northshore University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Rotator cuff repair without Suprascapular Nerve decompression

Rotator Cuff Repair with Suprascapular Nerve decompression

Arm Description

approximately 17 subjects in the study will receive traditional rotator cuff repair surgical intervention with no suprascapular nerve decompression surgical intervention

approximately 17 subjects in the study will undergo rotator cuff repair with arthroscopic suprascapular nerve decompression surgical intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Constant Shoulder Score

It includes pain score, functional assessment, range of motion and strength measures

Full Information

NCT ID

NCT02107573

First Posted

April 4, 2014

Last Updated

May 3, 2023

Sponsor

University of Chicago

Collaborators

NorthShore University HealthSystem

1. Study Identification

Unique Protocol Identification Number

NCT02107573

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 15, 2013 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Chicago

Collaborators

NorthShore University HealthSystem

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Tear

Keywords

Randomized Controlled Trial, Rotator Cuff Tear, Suprascapular Nerve, Decompression, Shoulder Surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rotator cuff repair without Suprascapular Nerve decompression

Arm Type

Active Comparator

Arm Description

approximately 17 subjects in the study will receive traditional rotator cuff repair surgical intervention with no suprascapular nerve decompression surgical intervention

Arm Title

Rotator Cuff Repair with Suprascapular Nerve decompression

Arm Type

Active Comparator

Arm Description

approximately 17 subjects in the study will undergo rotator cuff repair with arthroscopic suprascapular nerve decompression surgical intervention

Intervention Type

Procedure

Intervention Name(s)

Rotator Cuff Repair without Suprascapular Nerve decompression

Intervention Description

Traditional rotator cuff repair without Suprascapular nerve decompression

Intervention Type

Procedure

Intervention Name(s)

Rotator Cuff Repair with Suprascapular Nerve decompression

Intervention Description

Traditional rotator cuff repair with Suprascapular nerve decompression

Primary Outcome Measure Information:

Title

American Shoulder and Elbow Surgeons (ASES) Shoulder Score

Description

The scale measures pain from 0 to 10 and also includes a questionnaire for assessing the activity of daily living.

Time Frame

one year

Secondary Outcome Measure Information:

Title

Constant Shoulder Score

Description

It includes pain score, functional assessment, range of motion and strength measures

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lewis L Shi, MD

Organizational Affiliation

University of Chicago

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jason Koh, MD

Organizational Affiliation

Northshore University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Chicago Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Northshore University

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs