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

Phase 4

• Conditions: Health Condition 1: null- Patients who have been treated with Freedom® Total Knee System

• Registration Number: CTRI/2015/09/006178
• Lead Sponsor: Dr Haresh Bhalodiya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 450

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

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.

Study & Design

• Study Type: PMS
• Study Design: Not specified