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Recruiting NCT06002009

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

— Observational Orthopedic Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI, Nerve conduction study.
Who it may be relevant to
Registry conditions: Orthopedic Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Radiation MRI
    MRI of shoulder
  • Other Nerve conduction study
    Nerve conduction study

Primary outcome measures

  • Assess suprascapular nerve funaction [Time frame: 36 months]
Secondary outcome measures (4)
  • 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]

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
  • Patients unable or unwilling to comply with the study procedures

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • University Hospitals of North Midlands NHS Trust — Stoke-on-Trent

Identifiers

NCT: NCT06002009 · 3103

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗