Rotator Cuff TearNCT02107573
Comparing the Outcomes Between Rotator Cuff Repair With and Without Suprascapular Nerve Decompression
A study testing Rotator Cuff Repair without Suprascapular Nerve decompression and Rotator Cuff Repair with Suprascapular Nerve decompression in people with Rotator Cuff Tear, run by University of Chicago at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Rotator Cuff Repair without Suprascapular Nerve decompression and Rotator Cuff Repair with Suprascapular Nerve decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jul 2013to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reparable full thickness supraspinatus and or infraspinatus rotator cuff tears regardless of retraction
Who cannot join
- Patients less than 18 years of age
- Irreparable rotator cuff tears
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Chicago Medical Center
Chicago, Illinois, 60637
Northshore University
Evanston, Illinois, 60201
About this study
Official title: Will Routine Suprascapular Nerve Release During Arthroscopic Rotator Cuff Repair Improve Patient Outcomes?
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.
Read the 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.
- Conditions
- Rotator Cuff Tear
- Being tested
- Rotator Cuff Repair without Suprascapular Nerve decompression, Rotator Cuff Repair with Suprascapular Nerve decompression
- Keywords
- Randomized Controlled Trial, Rotator Cuff Tear, Suprascapular Nerve, Decompression, Shoulder Surgery
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotator Cuff Repair without Suprascapular Nerve decompressionProcedure or surgery
Traditional rotator cuff repair without Suprascapular nerve decompression
Rotator Cuff Repair with Suprascapular Nerve decompressionProcedure or surgery
Traditional rotator cuff repair with Suprascapular nerve decompression
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Rotator Cuff Repair with Suprascapular Nerve decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (1)
Constant Shoulder Score
It includes pain score, functional assessment, range of motion and strength measures
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study start15 Jul 2013
- Primary completion1 Jun 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Endeavor Health
- Responsible party
- Sponsor
- Investigators
- Lewis L Shi, MD, Principal investigator, University of ChicagoJason Koh, MD, Principal investigator, Northshore University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107573
- Sponsor's protocol ID
- IRB13-0099
- Status last verified
- May 2025
- First submitted
- 4 Apr 2014
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Will Routine Suprascapular Nerve Release During Arthroscopic Rotator Cuff Repair Improve Patient Outcomes?
- ClinicalTrials.gov ID
- NCT02107573
- Acronym / sponsor ID
- IRB13-0099
- Conditions
- Rotator Cuff Tear
- Keywords
- Randomized Controlled Trial, Rotator Cuff Tear, Suprascapular Nerve, Decompression, Shoulder Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Endeavor Health
- Study start
- 15 Jul 2013 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotator cuff repair without Suprascapular Nerve decompression | Active comparator | Procedure: Rotator Cuff Repair without Suprascapular Nerve decompressionapproximately 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 | Active comparator | Procedure: Rotator Cuff Repair with Suprascapular Nerve decompressionapproximately 17 subjects in the study will undergo rotator cuff repair with arthroscopic suprascapular nerve decompression surgical intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Reparable full thickness supraspinatus and or infraspinatus rotator cuff tears regardless of retraction
Key exclusion criteria (2 listed)
- Patients less than 18 years of age
- Irreparable rotator cuff tears
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotator Cuff Repair without Suprascapular Nerve decompressionTraditional rotator cuff repair without Suprascapular nerve decompression | Procedure or surgery | Rotator cuff repair without Suprascapular Nerve decompression |
| Rotator Cuff Repair with Suprascapular Nerve decompressionTraditional rotator cuff repair with Suprascapular nerve decompression | Procedure or surgery | Rotator Cuff Repair with Suprascapular Nerve decompression |
Primary outcome
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.
1 secondary outcome
Constant Shoulder Score
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: No
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Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lewis L Shi, MD principal investigator
University of Chicago
Jason Koh, MD principal investigator
Northshore University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotator Cuff Repair without Suprascapular Nerve decompression and Rotator Cuff Repair with Suprascapular Nerve decompression in people with Rotator Cuff Tear, run by University of Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Shoulder and Elbow Surgeons (ASES) Shoulder Score (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025; AzTrials last refreshed its copy on 30 Oct 2026.