OsteoarthritisMenTORNCT02684864
Meniscal Tear and Osteoarthritis Risk (MenTOR)
An observational study of Osteoarthritis, run by University of Oxford at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Non-interventional
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2016to Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Kennedy Insitute of Rheumatololgy, NDORMS, University of Oxford
Oxford, Oxfordshire, OX3 7FY
About this study
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
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.
- Conditions
- Osteoarthritis
- Being tested
- Non-interventional
- Keywords
- biomarker, inflammation, knee, prognosis
- Medical subject headings
- Osteoarthritis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
X ray Kellgren Lawrence (KL) change
X ray of knee.Change in KL grade over time will be measured.
Measured: 2 years
MRI semi-quantitative score
MRI knee. Change in semi-quantitative score over time will be measured.
Measured: 2 years
Oxford Knee Score - Activity and Participation Questionnaire (OKS-APQ)
The OKS-APQ will be used to document pain and symptoms, and compared with KOOS.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Fiona Watt, MD, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684864
- Sponsor's protocol ID
- PID 11499
- Acronym
- MenTOR
- Status last verified
- Nov 2020
- First submitted
- 20 Jan 2016
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02684864
- Acronym / sponsor ID
- MenTOR / PID 11499
- Conditions
- Osteoarthritis
- Keywords
- biomarker, inflammation, knee, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Study start
- Mar 2016 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventional | Other | – |
Primary outcome
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.
3 secondary outcomes
X ray Kellgren Lawrence (KL) change
Time frame: 2 years
MRI semi-quantitative score
Time frame: 2 years
Oxford Knee Score - Activity and Participation Questionnaire (OKS-APQ)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- OA centre homepageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona Watt, MD, PhD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcomes Score (KOOS)-4 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.