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

Orthopedic Disorder Clinical Trial

— SSCuFF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06002009
• Other study ID #: 3103
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: September 2029

Study information

• Verified date: August 2023
• Source: University Hospitals of North Midlands NHS Trust
• Contact: Megan Young
• Phone: 01782 675384
• Email: megan.young[@]uhnm.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: September 2029
• Est. primary completion date: September 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder
• Rotator Cuff Injuries

Intervention

Radiation:
• MRI
MRI of shoulder

Other:
• Nerve conduction study
Nerve conduction study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals of North Midlands NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Nerve recovery	Functional assessment of nerve recovery at 24 months post-injury for surgically repaired rotator cuff tears.	24 months
Secondary	Machine learning	Use of machine learning to investigate data set for optimum parameters or predictors	24 months
Secondary	Nerve conduction studies	Repeat Nerve Conduction Study investigations at 12 months post injury for all surgically managed participants and non-surgical patients to assess suprascapular nerve function	12 months