Meniscal Tear and Osteoarthritis Risk (MenTOR)

Osteoarthritis Clinical Trial

— MenTOR  

Official title:

Does the Biological Response to Degenerative Meniscal Tears or to Their Intervention Predict Future Osteoarthritis?: The Meniscal Tear and Osteoarthritis Risk (MenTOR) Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02684864
• Other study ID #: PID 11499
• Status: Active, not recruiting
• Start date: March 2016
• Est. completion date: February 2026

Study information

• Verified date: November 2020
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: February 2026
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• Non-interventional

Locations

Country	Name	City	State
United Kingdom	Kennedy Insitute of Rheumatololgy, NDORMS, University of Oxford	Oxford	Oxfordshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Injury and Osteoarthritis Outcomes Score (KOOS)-4	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.	2 years
Secondary	X ray Kellgren Lawrence (KL) change	X ray of knee.Change in KL grade over time will be measured.	2 years
Secondary	MRI semi-quantitative score	MRI knee. Change in semi-quantitative score over time will be measured.	2 years
Secondary	Oxford Knee Score - Activity and Participation Questionnaire (OKS-APQ)	The OKS-APQ will be used to document pain and symptoms, and compared with KOOS.	2 years

External Links

•   OA centre homepage