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Clinical Trials/NCT06002009
NCT06002009
Recruiting
Not Applicable

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

University Hospitals of North Midlands NHS Trust1 site in 1 country250 target enrollmentJune 23, 2025
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ConditionsOrthopedic Disorder

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Orthopedic Disorder
Sponsor
University Hospitals of North Midlands NHS Trust
Enrollment
250
Locations
1
Primary Endpoint
Assess suprascapular nerve funaction
Status
Recruiting
Last Updated
8 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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. 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.
Registry
clinicaltrials.gov
Start Date
June 23, 2025
End Date
September 30, 2029
Last Updated
8 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Nerve recovery(24 months)
  • Shoulder scores(36 months)
  • Nerve conduction studies(12 months)
  • Machine learning(24 months)

Study Sites (1)

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