Orthopedic DisorderSSCuFFNCT06002009
SupraScapular Cuff Study: Assessing the Effects of Size and Type of Rotator Cuff Tear on Suprascapular Nerve Function
An observational study of Orthopedic Disorder, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- MRI and Nerve conduction study
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Jun 2025to 30 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Participants will be recruited from the University Hospitals of North Midlands outpatient clinic
Who may be able to join
- 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).
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent
Megan Young, 01782675384, megan.young@uhnm.nhs.uk
Damian McClelland
About this study
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.
- Conditions
- Orthopedic Disorder
- Being tested
- MRI, Nerve conduction study
- Keywords
- Rotator cuff tear, Suprascapular nerve function
- Medical subject headings
- Musculoskeletal Diseases, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIRadiation
MRI of shoulder
Nerve conduction studyOther
Nerve conduction study
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess suprascapular nerve funaction
MRI scan to quantify size of rotator cuff tear, compared with Nerve Conduction Studies (NCS) to assess suprascapular nerve function.
Measured: 36 months
Secondary outcomes (4)
Shoulder scores
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).
Measured: 36 months
Nerve recovery
Functional assessment of nerve recovery at 24 months post-injury for surgically repaired rotator cuff tears.
Measured: 24 months
Machine learning
Use of machine learning to investigate data set for optimum parameters or predictors
Measured: 24 months
Nerve conduction studies
Repeat Nerve Conduction Study investigations at 12 months post injury for all surgically managed participants and non-surgical patients to assess suprascapular nerve function
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start23 Jun 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals of North Midlands NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damian McClelland, Principal investigator, University Hospital of North Midlands NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002009
- Sponsor's protocol ID
- 3103
- Acronym
- SSCuFF
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2023
- Last updated
- 3 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SupraScapular Cuff Study: Assessing the Effects of Size and Type of Rotator Cuff Tear on Suprascapular Nerve Function
- ClinicalTrials.gov ID
- NCT06002009
- Acronym / sponsor ID
- SSCuFF / 3103
- Conditions
- Orthopedic Disorder
- Keywords
- Rotator cuff tear, Suprascapular nerve function
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospitals of North Midlands NHS TrustUniversity, hospital or other
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 21 Aug 2023 (actual)
- 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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the University Hospitals of North Midlands outpatient clinic
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| MRIMRI of shoulder | Radiation | – |
| Nerve conduction studyNerve conduction study | Other | – |
Primary outcome
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.
4 secondary outcomes
Shoulder scores
Time frame: 36 months
Nerve recovery
Time frame: 24 months
Machine learning
Time frame: 24 months
Nerve conduction studies
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Damian McClelland principal investigator
University Hospital of North Midlands NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Disorder, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
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 11 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: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Young (01782 675384, megan.young@uhnm.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess suprascapular nerve funaction (time frame: 36 months). 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 3 Sep 2025; AzTrials last refreshed its copy on 1 Nov 2026.