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A real world, Clinical Evaluation of Performance and survivorship of Freedom® Total Knee System in Total Knee Arthroplasty

A real world, Clinical Evaluation of Performance and survivorship of Freedom® Total Knee System in Total Knee Arthroplasty

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2015/09/006178
Enrollment
450
Registered
2015-09-11
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- Patients who have been treated with Freedom® Total Knee System

Interventions

Intervention1: Orthopaedic Knee system: Not Applicable Intervention2: Freedom Knee system: Size: Various size Product Selection: Appropriate matching of the component will occur when the articular com

Sponsors

Dr Haresh Bhalodiya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female with age >= 18 years 2. The subjects who have been treated with Freedom® Total Knee System between 1st January 2010 and 31st December 2011 by Dr.Bhalodiya and his team. 3. The subjects who are contactable, willing to participate in the survey study by signing voluntary informed consent form in accordance with regulatory guidelines.

Exclusion criteria

Exclusion criteria: 1. The subjects who have been treated with Freedom® Total Knee System but have not completed 3 years after total knee replacement surgery. 2. Subjects who are unwilling to participate in the clinical study. 3. Subjects who have more than one type of knee implant i.e. who have implant/s other than Freedom® Total Knee System. 4. Subjects suffering from rheumatoid arthritis at the time of procedure. 5. Subjects who have undergone knee replacement due to accidental injury. 6. Subjects with BMI > 30.

Design outcomes

Primary

MeasureTime frame
Maximum Range of Motion in patients who have completed at least â?¥ 3 years after Total Knee Replacement surgeryTimepoint: Patients completed at least â?¥ 3 years;so patients treated between 1st January 2010 and 31st December 2011

Secondary

MeasureTime frame
1. To determine Clinical and Social Quality of life as per American Knee Society Score (AKSS). 2. To evaluate pain relief as per Modified WOMAC Pain and Stiffness Score.Timepoint: Patients completed at least â?¥ 3 years;so patients treated between 1st January 2010 and 31st December 2011

Countries

India

Contacts

Public ContactDr Haresh Bhalodiya

Saviour Hospital

hareshbhalodia2015@gmail.com9327099818

Outcome results

None listed

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