NCT04470245

Brief Summary

Cubital Tunnel Syndrome (CTS) results from compression of the ulnar nerve at the elbow (colloquially termed the "funny bone"). CTS affects up to 6% of the population and 6000 patients undergo surgery annually in the UK. Surgery is the only proven treatment for CTS, although up to 30% of patients do not improve. Therefore, there is a pressing need to develop a reliable test to diagnose CTS to improve the selection of patients for surgery. New techniques in the field of magnetic resonance imaging (MRI) allow the visualisation of nerve structure and function. Diffusion tensor MRI, also known as diffusion tensor imaging (DTI), can diagnose CTS with superior diagnostic accuracy and could enable the reliable diagnostic of CTS, improving the selection of patients for surgery. The study will include healthy volunteers (to refine the scanning sequence) and patients undergoing surgery for CTS. Patients will be scanned preoperatively and postoperatively using cutting-edge diffusion MRI techniques. The primary outcome will be change in the MRI-derived diffusion metrics following surgery. Secondary outcomes will consider how MRI relates to patient-reported outcomes and conventional clinical tests (ultrasound and nerve conduction studies). Leeds is the ideal location for this research because a) Leeds institutions are the most highly cited organisations in musculoskeletal research, b) Leeds houses the National Centre for Hyperpolarized MRI and a state-of-the-art MRI scanner, and c) Leeds is an internationally recognised centre of excellence for complex upper limb surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 8, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 8, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

1.3 years

First QC Date

July 8, 2020

Last Update Submit

July 13, 2020

Conditions

Cubital Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

  • The question is whether the MRI diffusion metrics of the ulnar nerve in patients with the cubital tunnel

    change following surgical decompression.

    60 minutes

Study Arms (2)

Healthy volunteers

ACTIVE COMPARATOR
Diagnostic Test: magnetic resonance imaging (MRI)

Patients undergoing surgery

ACTIVE COMPARATOR

We will include adults (over 18 years of age) undergoing surgical decompression of the ulnar nerve at the elbow for cubital tunnel syndrome.

Diagnostic Test: magnetic resonance imaging (MRI)

Interventions

magnetic resonance imaging (MRI)DIAGNOSTIC_TEST

Our study will include healthy volunteers (to refine the scanning sequence) and patients undergoing surgery for CTS. Patients will be scanned before and after their operation using cutting-edge diffusion MRI techniques.

Healthy volunteersPatients undergoing surgery

Eligibility Criteria

Age18 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults (over 18 years of age) undergoing surgical decompression of the ulnar nerve at the elbow for cubital tunnel syndrome.

You may not qualify if:

  • Unable to get into the MRI scanner due to habitus or claustrophobia
  • Unable to lie still due to any cause (eg. athetoid movements, dystonias, chorea, etc)
  • Intraocular or intracranial metallic foreign bodies
  • Active implants (eg. pacemakers, implantable cardiac defibrillators, nerve stimulators, etc) which are not MRI safe or conditional.
  • Pregnancy - whilst there are no known adverse effects of MRI16-18 to the mother or fetus, MRI is generally avoided in pregnancy due to the acoustic trauma19 and inductive heating generated by alternating magnetic fields.
  • Any metallic implants in the elbow

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cubital Tunnel Syndrome

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Ulnar NeuropathiesMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesUlnar Nerve Compression SyndromesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Ryckie Wade, MBBS DipHR MClinEd MRCS FHEA

CONTACT

ryckiewade@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2020

First Posted

July 14, 2020

Study Start

July 8, 2019

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations

GB(1)