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Collect & evaluate the information from Indian patients with osteoarthritis of the knee joint who are undergoing knee arthroscopy for meniscal tears and related treatment used for pain management, in daily clinical practice.

A prospective observational study to evaluate pain management in Indian patients with meniscus tear and associated knee osteoarthritis undergoing knee arthroscopy - ONE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/02/011896
Enrollment
400
Registered
2018-02-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Pain management in patients with meniscus tear and associated knee osteoarthritis undergoing knee arthroscopy Health Condition 2: S832- Tear of meniscus, current injury

Interventions

Intervention1: Not Applicable as it is a observational disease registry: NA

Sponsors

Sanofi IndiaLimited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient is 30-55 years of age 2. Patient with meniscal tear and associated radiographic evidence of knee osteoarthritis (with documented Kellgren-Lawrence (KL )grade I/II/III) and undergoing knee arthroscopy 3. Signed Informed consent obtained prior to any study related procedures

Exclusion criteria

Exclusion criteria: 1. Patients undergoing arthroscopy for indications other than meniscal surgeries 2. Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.

Design outcomes

Primary

MeasureTime frame
Management of pain for the study duration of one year (the different classes of drugs, their route of administration and duration used for pain management )Timepoint: The study visits where the primary end point data will be collected are baseline, v2 at one&half months, v3 at three months, v4 at six months and v5 (EOS) at one year.

Secondary

MeasureTime frame
Cartilage damage would be determined using the Outerbridge classification at the time of arthroscopy . Mean change in VAS score at the end of the study as compared to baselineTimepoint: The study visits where the secondary end point data will be collected are baseline, v2 at one&half months, v3 at three months, v4 at six months and v5 (EOS) at one year

Countries

India

Contacts

Public ContactMs Shraddha Bhatia

Sanofi India Limited

vaibhav.salvi@sanofi.com9869226697

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026