Meniscal Tear and Osteoarthritis Risk (MenTOR)

NCT ID: NCT02684864

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2026-02-28

Brief Summary

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Adults with degenerative meniscal tear receiving arthroscopic surgical management or knee drainage (arthrocentesis) +/- intra-articular steroid injection will be recruited to this non-interventional cohort study. The aim is to investigate whether measurement of an individual's synovial fluid biomarker response to a degenerative meniscal tear with symptoms predicts symptomatic and functional outcome suggestive of osteoarthritis (OA) of the knee.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Non-interventional

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Male or female aged 30-60 years.
2. Participant able and willing to give informed consent.
3. Clinical assessment demonstrates mechanical symptoms suggestive of meniscal pathology (focal knee pain +/- 1 or more of: catching/locking, giving way, focal joint-line tenderness, effusion, McMurray's positive) within last 12 months.
4. Evidence on clinical MRI knee of meniscal tear.
5. Participant is either in secondary care or has the potential to be referred to secondary care due to severity of symptoms.
6. Patient has failed conservative therapy and elected for surgical arthroscopic treatment, or is due knee drainage/injection for clinical reasons.
7. Competency of the English language to complete questionnaires independently.

Exclusion Criteria

1. Pre-existing advanced radiographic OA (KL grade 3-4) of index knee at baseline.
2. Evidence of anterior cruciate ligament rupture, or more extensive soft tissue injury.
3. History of an acute knee injury (within 12 weeks), or acutely locked knee
4. Known history of inflammatory/septic arthritis of index knee.
5. Knee replacement or other non-arthroscopic knee surgery (e.g. high tibial osteotomy) - previous or planned within 1 year of study start.
6. Index knee surgery within last 3 months, including meniscectomy.
7. Steroid injection to index knee in last 3 months.
8. Active other (treated) inflammatory disease or infection.
9. Positive pregnancy test.
10. Unable to provide blood samples.
11. Unable to give informed written consent.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oxford University Hospitals NHS Trust

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fiona Watt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

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Kennedy Insitute of Rheumatololgy, NDORMS, University of Oxford

Oxford, Oxfordshire, United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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Other Identifiers

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PID 11499

Identifier Type: -

Identifier Source: org_study_id

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