NCT02107573

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 11, 2025

Status Verified

May 1, 2025

Enrollment Period

10.9 years

First QC Date

April 4, 2014

Last Update Submit

May 6, 2025

Conditions

Keywords

Randomized Controlled TrialRotator Cuff TearSuprascapular NerveDecompressionShoulder Surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    one year

Secondary Outcomes (1)

  • Constant Shoulder Score

    one year

Study Arms (2)

Rotator cuff repair without Suprascapular Nerve decompression

ACTIVE COMPARATOR

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

Rotator Cuff Repair with Suprascapular Nerve decompression

ACTIVE COMPARATOR

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

Interventions

Traditional rotator cuff repair without Suprascapular nerve decompression

Rotator cuff repair without Suprascapular Nerve decompression

Traditional rotator cuff repair with Suprascapular nerve decompression

Rotator Cuff Repair with Suprascapular Nerve decompression

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Northshore University

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Lewis L Shi, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR
  • Jason Koh, MD

    Northshore University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2014

First Posted

April 8, 2014

Study Start

July 15, 2013

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

May 11, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations