MOVE: Magnetic Resonance Imaging to Assess Changes in Meniscus Vascularity

Sponsor

The Leeds Teaching Hospitals NHS Trust (Other)

Overall Status

Unknown status

CT.gov ID

NCT02363140

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

Brief Summary

The menisci in the knee joint are important for normal functioning of the knee. Meniscus tears are amongst the commonest of injuries to the knee. The pattern and blood supply of the meniscus tears determines the treatment plan and outcome. The surgeon identifies the blood supply to the meniscus tear area during the arthroscopy(key hole operation) and decides the treatment option ie repair versus partial meniscectomy.

This study aims to identify any changes that occur in the meniscus blood supply. The following are the main aims of the 'MOVE'study-

Use of non-invasive methods ie MRImaging to assess meniscus vascularity to preoperatively plan treatment and advice patient on recovery.
The study would assess changes in meniscus blood supply depending on age of the patient.
The study aims to assess the alteration in meniscus blood supply following an arthroscopic(key hole) meniscal repair operation.

Condition or Disease	Intervention/Treatment	Phase
Meniscus Tears	Other: Will undergo a single MRI assessment with intravenous dye Other: pre and post surgery MRI scan	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Group One patients in age group 18--20 years, Patients should be aged 18--20 years or 35--45years Asymptomatic knee for past 6 months. Painless flexion-extension movements at knee joint.
Active Comparator: Group Two patients in age group 35-45 years, Patients should be aged 18--20 years or 35--45years Asymptomatic knee for past 6 months. Painless flexion-extension movements at knee joint.	Other: Will undergo a single MRI assessment with intravenous dye
Active Comparator: Group Three Patients aged 75 Patients should be aged 75 or older Knee X-ray showing no more than Kellgren-Lawrence grade II osteoarthrtis No clinical suspicion of meniscus tear Painless flexion-extension movements at knee joint.	Other: Will undergo a single MRI assessment with intravenous dye
Active Comparator: Group Four, any age due to undergo a surgical meniscus repair 1. Patients should have presented with clinical signs to suggest meniscus tear indicating potential need for surgical meniscus repair	Other: pre and post surgery MRI scan

Outcome Measures

Primary Outcome Measures

Primary outcome is to assess meniscus vascularity in-vivo by use of MR imaging technique. [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Inclusion criteria for Group I,II

Patients should be aged 18-20 years or 35-45years
Asymptomatic knee for past 6 months.
Painless flexion-extension movements at knee joint.

Inclusion criteria for Group III

Patients should be aged 75 or older
Knee X-ray showing no more than Kellgren-Lawrence grade II osteoarthrtis
No clinical suspicion of meniscus tear
Painless flexion-extension movements at knee joint.

Inclusion criteria for Group IV

Patients should have presented with clinical signs to suggest meniscus tear indicating potential need for surgical meniscus repair.

Exclusion Criteria:

Proven Polyarthritis / Polyarthralgia secondary to Rheumatoid arthritis, Gout, Lupus, Ankylosing Spondylosis, Psoriatic arthritis
Any previous surgical procedure(open or arthroscopic) involving the knee joint.(baring the current meniscus repair in Group IV participants)
Patients unable to give informed consent.
Patients with contraindication for MR Imaging - Metal implants, prosthetic heart valves, pacemakers, metal foreign bodies, VP shunts, pregnancy, cochlear implant, metal clips in the brain, Patients with static tremor i.e. Parkinson's disease.
Patients with contraindications for contrast agent - Renal impairment, Previous allergic reaction.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The Leeds Teaching Hospitals NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Leeds Teaching Hospitals NHS Trust

ClinicalTrials.gov Identifier:

NCT02363140

Other Study ID Numbers:

OR11/9770

First Posted:

Feb 13, 2015

Last Update Posted:

Feb 19, 2016

Last Verified:

Feb 1, 2016

Keywords provided by The Leeds Teaching Hospitals NHS Trust

Musculoskeletal System

Study Results

No Results Posted as of Feb 19, 2016