Freedom® Total Knee System for Treatment of Osteoarthritis, Rheumatoid Arthritis or Post-traumatic Arthritis

Summary

Participation Requirements

Description

At all the clinical/telephonic follow-up visits i.e. at 8 weeks ± 1week, 1 year ± 1 month, 3 years ± 6 months, 5 years ± 6 months and 10 years ± 6 months implant survivorship and vital signs such as weight, heart rate etc including blood pressure will be recorded. Physical examination, lab measureme...

At all the clinical/telephonic follow-up visits i.e. at 8 weeks ± 1week, 1 year ± 1 month, 3 years ± 6 months, 5 years ± 6 months and 10 years ± 6 months implant survivorship and vital signs such as weight, heart rate etc including blood pressure will be recorded. Physical examination, lab measurements (optional), Radiographic assessment, concomitant medication/surgery and AE/SAE should be recorded. Also at all clinical follow ups OKS, KSS, range of motion will be recorded. The post-operative radiographic evaluations will be conducted at 0-8 weeks ± 1 week (which is considered as standard of care), 1 year ± 1 month, 3 years ± 6 months and optionally at 5 years ± 6 months, 10 years ± 6 months and Unscheduled visits, if required. The unscheduled visit is expected in some patients based on the fact that such patients might prone to complications like surgical site infections, venous thrombotic events, acute blood loss causing anaemia, nerve injury, and pain unresponsive to oral analgesics.

Tracking Information