SupraScapular Cuff Study: Assessing the Effects of Size and Type of Rotator Cuff Tear on Suprascapular Nerve Function (SSCuFF)

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

  1. To determine if an injured suprascapular nerve can recover if the rotator cuff tear is surgically repaired.
  2. To determine if there is a limit of retraction before the suprascapular nerve is irreversibly damaged.
  3. To determine factors that are protective against SSN injury.
  4. Can the patient data gathered be used to optimise operative procedures.

Study Overview

Status

Recruiting

Conditions

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

Study Locations

      • Stoke-on-Trent, United Kingdom
        • Recruiting
        • University Hospitals of North Midlands NHS Trust
        • Contact:
        • 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

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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