NCT06002009

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. 1.To determine if an injured suprascapular nerve can recover if the rotator cuff tear is surgically repaired.
  2. 2.To determine if there is a limit of retraction before the suprascapular nerve is irreversibly damaged.
  3. 3.To determine factors that are protective against SSN injury.
  4. 4.Can the patient data gathered be used to optimise operative procedures.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
41mo left

Started Jun 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Jun 2025Sep 2029

First Submitted

Initial submission to the registry

August 8, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 23, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

3.3 years

First QC Date

August 8, 2023

Last Update Submit

August 26, 2025

Conditions

Keywords

Rotator cuff tearSuprascapular nerve function

Outcome Measures

Primary Outcomes (1)

  • 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 (4)

  • Shoulder scores

    36 months

  • Nerve recovery

    24 months

  • Machine learning

    24 months

  • Nerve conduction studies

    12 months

Interventions

MRIRADIATION

MRI of shoulder

Nerve conduction study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, United Kingdom

RECRUITING

MeSH Terms

Conditions

Musculoskeletal DiseasesRotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Damian McClelland

    University Hospital of North Midlands NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 21, 2023

Study Start

June 23, 2025

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2029

Last Updated

September 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations