NCT02684864

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

April 1, 2021

Status Verified

November 1, 2020

Enrollment Period

6.9 years

First QC Date

January 20, 2016

Last Update Submit

March 30, 2021

Conditions

Osteoarthritis

Keywords

biomarkerinflammationkneeprognosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • X ray Kellgren Lawrence (KL) change

    2 years

  • MRI semi-quantitative score

    2 years

  • Oxford Knee Score - Activity and Participation Questionnaire (OKS-APQ)

    2 years

Interventions

Non-interventionalOTHER

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Male or female aged 30-60 years.
  • Participant able and willing to give informed consent.
  • 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.
  • Evidence on clinical MRI knee of meniscal tear.
  • Participant is either in secondary care or has the potential to be referred to secondary care due to severity of symptoms.
  • Patient has failed conservative therapy and elected for surgical arthroscopic treatment, or is due knee drainage/injection for clinical reasons.
  • Competency of the English language to complete questionnaires independently.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kennedy Insitute of Rheumatololgy, NDORMS, University of Oxford

Oxford, Oxfordshire, OX3 7FY, United Kingdom

Location

Related Links

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).

MeSH Terms

Conditions

OsteoarthritisInflammation

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Fiona Watt, MD, PhD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2016

First Posted

February 18, 2016

Study Start

March 1, 2016

Primary Completion

February 1, 2023

Study Completion

February 1, 2026

Last Updated

April 1, 2021

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)