Magnetic Resonance Imaging to Assess Changes in Meniscus Vascularity

NCT02363140 | Unknown

• 1 other identifier: OR11/9770
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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-

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

Conditions

Meniscus Tears

Keywords

Musculoskeletal System

Outcome Measures

Primary Outcomes (1)

• Primary outcome is to assess meniscus vascularity in-vivo by use of MR imaging technique.

  6 months

Study Arms (4)

Group One patients in age group 18--20 years,

NO INTERVENTION

1. Patients should be aged 18--20 years or 35--45years 2. Asymptomatic knee for past 6 months. 3. Painless flexion-extension movements at knee joint.

Group Two patients in age group 35-45 years,

ACTIVE COMPARATOR

1. Patients should be aged 18--20 years or 35--45years 2. Asymptomatic knee for past 6 months. 3. Painless flexion-extension movements at knee joint.

Other: Will undergo a single MRI assessment with intravenous dye

Group Three Patients aged 75

ACTIVE COMPARATOR

1. Patients should be aged 75 or older 2. Knee X-ray showing no more than Kellgren-Lawrence grade II osteoarthrtis 3. No clinical suspicion of meniscus tear 4. Painless flexion-extension movements at knee joint.

Other: Will undergo a single MRI assessment with intravenous dye

Group Four, any age due to undergo a surgical meniscus repair

ACTIVE COMPARATOR

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

Interventions

Will undergo a single MRI assessment with intravenous dye OTHER

Group Three Patients aged 75; Group Two patients in age group 35-45 years,

pre and post surgery MRI scan OTHER

Group Four, any age due to undergo a surgical meniscus repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients should be aged 18-20 years or 35-45years
• Asymptomatic knee for past 6 months.
• Painless flexion-extension movements at knee joint.
• 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.
• \. Patients should have presented with clinical signs to suggest meniscus tear indicating potential need for surgical meniscus repair.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

MeSH Terms

Interventions

Lead

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 13, 2015
• Study Start: June 1, 2012
• Primary Completion: June 1, 2015
• Last Updated: February 19, 2016

Record last verified: 2016-02