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Meniscal Tear and Osteoarthritis Risk (MenTOR) (MenTOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02684864
Recruitment Status : Recruiting
First Posted : February 18, 2016
Last Update Posted : January 16, 2019
Sponsor:
Collaborator:
Oxford University Hospitals NHS Trust
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Osteoarthritis Other: Non-interventional

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : March 2016
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis Tears




Primary Outcome Measures :
  1. Knee Injury and Osteoarthritis Outcomes Score (KOOS)-4 [ Time Frame: 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 :
  1. X ray Kellgren Lawrence (KL) change [ Time Frame: 2 years ]
    X ray of knee.Change in KL grade over time will be measured.

  2. MRI semi-quantitative score [ Time Frame: 2 years ]
    MRI knee. Change in semi-quantitative score over time will be measured.

  3. Oxford Knee Score - Activity and Participation Questionnaire (OKS-APQ) [ Time Frame: 2 years ]
    The OKS-APQ will be used to document pain and symptoms, and compared with KOOS.


Biospecimen Retention:   Samples With DNA
Blood samples (plasma, serum, DNA where consent is given), urine, synovial fluid (where an appropriate clinically indicated procedure has been carried out to allow access).


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a confirmed meniscal tear, likely degenerative in nature, will be invited to participate in the MenTOR study. Male and female adults with a MRI-evident meniscal tear and evidence of no/minor osteoarthritic change (KL grade 2 or less) who are undergoing arthroscopic treatment, or planned arthrocentesis/injection will be identified in clinics all located at the Nuffield Orthopaedic Centre (NOC). The primary source of recruitment is anticipated to be the secondary care orthopaedic knee service. The patient's symptoms will be such that they warrant further management.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02684864


Contacts
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Contact: Fiona Watt, MD, PhD fiona.watt@kennedy.ox.ac.uk

Locations
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United Kingdom
Kennedy Insitute of Rheumatololgy, NDORMS, University of Oxford Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7FY
Contact: Fiona E Watt, MD, PhD       fiona.watt@kennedy.ox.ac.uk   
Sponsors and Collaborators
University of Oxford
Oxford University Hospitals NHS Trust
Investigators
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Principal Investigator: Fiona Watt, MD, PhD University of Oxford
Additional Information:
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02684864    
Other Study ID Numbers: PID 11499
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Oxford:
biomarker
inflammation
knee
prognosis
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases