- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06002009
SupraScapular Cuff Study: Assessing the Effects of Size and Type of Rotator Cuff Tear on Suprascapular Nerve Function (SSCuFF)
August 26, 2025 updated by: University Hospitals of North Midlands NHS Trust
The primary objective of the study is to determine in adult patients with a rotator cuff tear, what size and pattern of rotator cuff tear would result in damage to the suprascapular nerve.
The secondary objectives are
- To determine if an injured suprascapular nerve can recover if the rotator cuff tear is surgically repaired.
- To determine if there is a limit of retraction before the suprascapular nerve is irreversibly damaged.
- To determine factors that are protective against SSN injury.
- Can the patient data gathered be used to optimise operative procedures.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Megan Young
- Phone Number: 01782 675384
- Email: megan.young@uhnm.nhs.uk
Study Locations
-
-
-
Stoke-on-Trent, United Kingdom
- Recruiting
- University Hospitals of North Midlands NHS Trust
-
Contact:
- Megan Young
- Phone Number: 01782675384
- Email: megan.young@uhnm.nhs.uk
-
Principal Investigator:
- Damian McClelland
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Participants will be recruited from the University Hospitals of North Midlands outpatient clinic
Description
Inclusion Criteria:
• All patients age ≥18 years presenting to a UHNM shoulder clinic with a confirmed diagnosis of a rotator cuff tear (affecting one or both shoulders).
Exclusion Criteria:
- Bony pathology (such as significant shoulder arthritis that would exclude isolated rotator cuff repair)
- Grossly abnormal shoulder anatomy
- Motor Neurone Disease
- Cervical cord disease affecting the SSN nerve roots
- Patients unable to undergo MRI scan
- Previous surgery at the affected glenohumeral joint
- Patients unable to tolerate NCS
- Acute fracture affecting the glenohumeral joint
- Recent glenohumeral joint dislocation (past 12 months)
- Patients unable or unwilling to give full informed consent
- Patients unable or unwilling to comply with the study procedures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess suprascapular nerve funaction
Time Frame: 36 months
|
MRI scan to quantify size of rotator cuff tear, compared with Nerve Conduction Studies (NCS) to assess suprascapular nerve function.
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder scores
Time Frame: 36 months
|
Compare functional shoulder scores to the degree of nerve injury and muscle degeneration over a 24-month period post-injury.
Scores to include active range of movement (ROM) measurements; and the collection of validated shoulder outcome scores (DASH, OSS, & Constant score).
|
36 months
|
|
Nerve recovery
Time Frame: 24 months
|
Functional assessment of nerve recovery at 24 months post-injury for surgically repaired rotator cuff tears.
|
24 months
|
|
Machine learning
Time Frame: 24 months
|
Use of machine learning to investigate data set for optimum parameters or predictors
|
24 months
|
|
Nerve conduction studies
Time Frame: 12 months
|
Repeat Nerve Conduction Study investigations at 12 months post injury for all surgically managed participants and non-surgical patients to assess suprascapular nerve function
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Damian McClelland, University Hospital of North Midlands NHS Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 23, 2025
Primary Completion (Estimated)
September 30, 2028
Study Completion (Estimated)
September 30, 2029
Study Registration Dates
First Submitted
August 8, 2023
First Submitted That Met QC Criteria
August 18, 2023
First Posted (Actual)
August 21, 2023
Study Record Updates
Last Update Posted (Estimated)
September 3, 2025
Last Update Submitted That Met QC Criteria
August 26, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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