- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02363140
Magnetic Resonance Imaging to Assess Changes in Meniscus Vascularity (MOVE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
1. 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Group One patients in age group 18--20 years,
|
|
Active Comparator: Group Two patients in age group 35-45 years,
|
|
Active Comparator: Group Three Patients aged 75
|
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Primary outcome is to assess meniscus vascularity in-vivo by use of MR imaging technique.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- OR11/9770
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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