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

Not Applicable

Recruiting

Brief Summary: This is prospective, single arm, multi-centre, observational, real world, post marketing surveillance to evaluate implant survivorship and performance of the FreedomÂ® Total Knee System in total knee arthroplasty in minimum 400 patients in India at minimum 15-20 centres.

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available FreedomÂ® Total Knee System used in total knee arthroplasty at different time points [Time Frame: 6 weeks, 6 months, 1 year, 3 years, 5 years, 7 years and 10 years].

All eligibel subjects based on inclusion/exclusion will be approached to sign Informed Consent form approved by respective ethics committee before starting the study related process. FreedomÂ® Total Knee System is indicated in subjects with Subjects suffering from severe knee joint pain, loss of mobility and disability due to rheumatoid arthritis, osteoarthritis, function deformities, post traumatic loss of knee joint contour. The subject will be kept on a standard regimen in post operative and follow-up period. Subjectâ€™s clinical follow-up will be taken at 6 weeks (Â± 15 days), 6 months (Â± 28 days), 1 year (Â± 1 month), 3 years (Â± 1 month), 5 years (Â± 1 month), 7 years (Â± 1 month), 10 years (Â± 1 month).

Recruitment & Eligibility

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

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.

Primary Outcome Measures

Name	Time	Method
1.Implant Survivorship	6 weeks, 6 months, 1 year, 3 years, 5 years , 7 years and 10 years
2.Cumulative Revision	6 weeks, 6 months, 1 year, 3 years, 5 years , 7 years and 10 years
Rate	6 weeks, 6 months, 1 year, 3 years, 5 years , 7 years and 10 years

Secondary Outcome Measures

Name	Time	Method
1.Knee Society Score	2.WOMAC (Western Ontario

Locations (24): All India Institute Of Medical Sciences
🇮🇳
Delhi, DELHI, India
Amandeep Hospital
🇮🇳
Amritsar, PUNJAB, India
Apollo Gleneagles Hospitals
🇮🇳
Kolkata, WEST BENGAL, India
Apollo Hospital
🇮🇳
Indore, MADHYA PRADESH, India
Artemis Health Institute
🇮🇳
Gurgaon, HARYANA, India
Curae Hospital
🇮🇳
Thane, MAHARASHTRA, India
Deenanath Mangeshkar Hospital and Research Center
🇮🇳
Pune, MAHARASHTRA, India
Dr. Sanjay B. Londheâ€™s Clinic
🇮🇳
Mumbai, MAHARASHTRA, India
Fortis Hospital
🇮🇳
Ludhiana, PUNJAB, India
Globus Hospital
🇮🇳
Nagar, UTTAR PRADESH, India
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All India Institute Of Medical Sciences
🇮🇳Delhi, DELHI, India
Dr Chandra Shekhar Yadav
Principal investigator
9868479933
csyadavortho@gmail.com