Meniscal Tear and Osteoarthritis Risk (MenTOR)

Active, not recruiting

• Conditions: Osteoarthritis

• Registration Number: NCT02684864
• Lead Sponsor: University of Oxford

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-01-20
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-18
• Study Start: 2016-03
• Status Verified: 2020-11
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-01
• Primary Completion: 2023-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcomes Score (KOOS)-4	2 years	summary score from validated KOOS questionnaire. 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 OA of the knee.

Secondary Outcome Measures

Name	Time	Method
Oxford Knee Score - Activity and Participation Questionnaire (OKS-APQ)	2 years	The OKS-APQ will be used to document pain and symptoms, and compared with KOOS.
X ray Kellgren Lawrence (KL) change	2 years	X ray of knee.Change in KL grade over time will be measured.
MRI semi-quantitative score	2 years	MRI knee. Change in semi-quantitative score over time will be measured.

Trial Locations

Locations (1)

Kennedy Insitute of Rheumatololgy, NDORMS, University of Oxford; 🇬🇧 Oxford, Oxfordshire, United Kingdom