Meniscus TearsMOVENCT02363140
Magnetic Resonance Imaging to Assess Changes in Meniscus Vascularity
A study testing Will undergo a single MRI assessment with intravenous dye and pre and post surgery MRI scan in people with Meniscus Tears, run by The Leeds Teaching Hospitals NHS Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniscus Tears
- What is being tested?
- Will undergo a single MRI assessment with intravenous dye and pre and post surgery MRI scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 1. Patients should have presented with clinical signs to suggest meniscus tear indicating potential need for surgical meniscus repair.
Who cannot join
- 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.
About this study
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.
- Conditions
- Meniscus Tears
- Being tested
- Will undergo a single MRI assessment with intravenous dye, pre and post surgery MRI scan
- Keywords
- Musculoskeletal System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Will undergo a single MRI assessment with intravenous dyeOther
pre and post surgery MRI scanOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Other: pre and post surgery MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome is to assess meniscus vascularity in-vivo by use of MR imaging technique.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startJun 2012
- Primary completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363140
- Sponsor's protocol ID
- OR11/9770
- Acronym
- MOVE
- Status last verified
- Feb 2016
- First submitted
- 9 Feb 2015
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging to Assess Changes in Meniscus Vascularity
- ClinicalTrials.gov ID
- NCT02363140
- Acronym / sponsor ID
- MOVE / OR11/9770
- Conditions
- Meniscus Tears
- Keywords
- Musculoskeletal System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2015 (actual)
- First posted
- 13 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Will undergo a single MRI assessment with intravenous dye1. 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 Three Patients aged 75 | Active comparator | Other: Will undergo a single MRI assessment with intravenous dye1. 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. |
| Group Four, any age due to undergo a surgical meniscus repair | Active comparator | Other: pre and post surgery MRI scan1. Patients should have presented with clinical signs to suggest meniscus tear indicating potential need for surgical meniscus repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Primary outcome is to assess meniscus vascularity in-vivo by use of MR imaging technique.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Will undergo a single MRI assessment with intravenous dye and pre and post surgery MRI scan in people with Meniscus Tears, run by The Leeds Teaching Hospitals NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome is to assess meniscus vascularity in-vivo by use of MR imaging technique. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.