Post Marketinng Surveillance to Evaluate implant survivorship and performance of the Freedom® Total Knee System in Total Knee Arthroplasty

A prospective, single arm, multi-centre, observational, real world, post marketing surveillance to evaluate implant survivorship and performance of the Freedom® Total Knee System in total knee arthroplasty. - Freedom® 400

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2016/11/007455

Enrollment

400

Registered

2016-11-09

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

Health Condition 1: M179- Osteoarthritis of knee, unspecified

Interventions

Intervention1: Freedom® Total Knee System: Freedom® Total Knee System in Total Knee Arthroplasty Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject is male or non-pregnant female aged 18 years or older at the time of study. 2. Subject is willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent Form. 3. Subject is a candidate for a total knee arthroplasty 4. Subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations

Exclusion criteria

Exclusion criteria: 1. Subject with a BMI greater than or equal to 40 2. Subject with an active infection within the affected knee joint 3. Subject with neuromuscular or neurosensory deficiency that may limit ability of the patient to evaluate the safety and efficacy of the device 4. Subject with a known sensitivity to device materials 5. Subject is unwilling or unable to sign the Informed Consent Document. 6. Subject with short Life expectancy less than 5 years (e.g. Cancer, HIV/AIDS) 7. Subject with history of deep vein thrombosis or other thrombotic disorders. 8. Subject with conditions such as Parkinsonism, loco motors ataxia, spinal scoliosis or kyphosis, stroke etc. that would affect their loco motors stability and interfere with assessment of Range of Motion of the target Knee. 9. Subject who, in consideration of treating doctor, would not be suitable for compliance of the follow up

Design outcomes

Primary

Measure	Time frame
1.Implant Survivorship 2.Cumulative Revision RateTimepoint: 6 weeks, 6 months, 1 year, 3 years, 5 years , 7 years and 10 years	—

Secondary

Measure	Time frame
1. Knee Society Score 2. WOMAC (Western Ontario and McMaster Universities Osteoarthritis) Pain 3. Range of Motion 4. SF-36 Questionnaire Short Form Health Survey questionnaire) 5. Radio graphic Analysis 6. Adverse EventsTimepoint: Pre-Op, 6 weeks, 6 months, 1year, 3, 5, 7 and 10 years	—

Countries

India

Contacts

Public ContactDr Ashok Thakkar

Deenanath Mangeshkar Hospital and Research Center

hwakankar@gmail.com09921131122

Outcome results

None listed

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