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

Not yet recruiting

• Conditions: Orthopedic Disorder

• Registration Number: NCT06002009
• Lead Sponsor: University Hospitals of North Midlands NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-08
• Study First Submitted QC: 2023-08-18
• Study First Posted: 2023-08-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04
• Study Start: 2025-04-22
• Primary Completion: 2028-09-30
• Study Completion: 2029-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Nerve recovery	24 months	Functional assessment of nerve recovery at 24 months post-injury for surgically repaired rotator cuff tears.
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).
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
Machine learning	24 months	Use of machine learning to investigate data set for optimum parameters or predictors