On Real world population to evaluate clinical performance and survivorship of freedomin Total Knee system
- Conditions
- Health Condition 1: null- Patients who have been treated with Freedom®Total Knee System
- Registration Number
- CTRI/2015/11/006372
- Lead Sponsor
- Dr Avtar singh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 150
1. Male or female with age >= 18 years
2. The subjects who have been completed at least >= 3 years after Total Knee Replacement surgery treated with Freedom® Total Knee System by Dr. Avtar Singh 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.
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
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum Range of Motion in patients who have been completed at least � 3 years after Total Knee Replacement surgery.Timepoint: The subjects who have been completed at least � 3 years after Total Knee Replacement surgery treated with Freedom® Total Knee System
- Secondary Outcome Measures
Name Time Method 1. To determine Clinical and Social Quality of life <br/ ><br>as per American Knee Society Score (AKSS). <br/ ><br>2. To evaluate pain relief as per Modified <br/ ><br>WOMAC Pain and Stiffness Score.Timepoint: The subjects who have been completed at least � 3 years after Total Knee Replacement surgery treated with Freedom® Total Knee System