SupraScapular Cuff Study: Assessing the Effects of Size a... | NCT06002009

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

NCT06002009

Sponsor

University Hospitals of North Midlands NHS Trust

Status

Recruiting

Last Update Posted

Sep 3, 2025Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Orthopedic Disorder

Interventions

MRI
Nerve conduction study

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 23, 2025Actual

Primary Completion Date

Sep 30, 2028Estimated

Completion Date

Sep 30, 2029Estimated

First Submitted Date

Aug 8, 2023

First Submission Date that Met QC Criteria

Aug 18, 2023

First Posted Date

Aug 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2025

Last Update Posted Date

Sep 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Radiation	MRI of shoulder
Nerve conduction study	Other	Nerve conduction study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess suprascapular nerve funaction	MRI scan to quantify size of rotator cuff tear, compared with Nerve Conduction Studies (NCS) to assess suprascapular nerve function.	36 months

Secondary Outcomes

Measure	Description	Time Frame
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).	36 months
Nerve recovery

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Participants will be recruited from the University Hospitals of North Midlands outpatient clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Megan Young	Contact	01782 675384		megan.young@uhnm.nhs.uk

Overall Officials

Name	Affiliation	Role
Damian McClelland	University Hospital of North Midlands NHS Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals of North Midlands NHS Trust	Recruiting	Stoke-on-Trent			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009140	Musculoskeletal Diseases
D000070636	Rotator Cuff Injuries

Ancestor Terms

ID	Term
D012421	Rupture
D014947	Wounds and Injuries
D000070599	Shoulder Injuries
D013708	Tendon Injuries

Browse Leaves

Not provided

Browse Branches

Not provided