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

Sponsor
University Hospitals of North Midlands NHS Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06002009
Collaborator
(none)
250
72

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: MRI
  • Other: Nerve conduction study

Study Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
SupraScapular Cuff Study: Assessing the Effects of Size and Type of Rotator Cuff Tear on Suprascapular Nerve Function
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2028
Anticipated Study Completion Date :
Sep 1, 2029

Outcome Measures

Primary Outcome Measures

  1. Assess suprascapular nerve funaction [36 months]

    MRI scan to quantify size of rotator cuff tear, compared with Nerve Conduction Studies (NCS) to assess suprascapular nerve function.

Secondary Outcome Measures

  1. Shoulder scores [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).

  2. Nerve recovery [24 months]

    Functional assessment of nerve recovery at 24 months post-injury for surgically repaired rotator cuff tears.

  3. Machine learning [24 months]

    Use of machine learning to investigate data set for optimum parameters or predictors

  4. Nerve conduction studies [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospitals of North Midlands NHS Trust

Investigators

  • Study Chair: Damian McClelland, University Hospital of North Midlands NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospitals of North Midlands NHS Trust
ClinicalTrials.gov Identifier:
NCT06002009
Other Study ID Numbers:
  • 3103
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospitals of North Midlands NHS Trust
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2023