NCT04033588

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

A Prospective, Multi-centre, Non-comparative, Post-market Clinical Follow-up Study to Evaluate the Survivorship, Safety and Performance of the Freedom® Total Knee System in United Kingdom.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Meril Life Sciences Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A prospective, multi-centre, non-comparative, post-market clinical follow-up study to evaluate the survivorship, safety and performance of the Freedom® Total Knee System in the treatment of approximately 450 subjects who in the surgeon's opinion require a primary total knee replacement due to severe knee joint pain and loss of mobility due to osteoarthritis, rheumatoid arthritis or post-traumatic arthritis at upto 15 centers in the United Kingdom (UK). The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Freedom® Total Knee System used in total knee replacement. Subjects must meet all the study inclusion / exclusion criteria before enrolment in the study. Subjects will be requested to attend out-patients clinic for clinical follow-up (CFU) or approached for telephonic follow-up (TFU) post-operatively as mentioned below. Clinical \& Telephonic Follow-up details: * 6-8 weeks ± 1week (Clinical follow-up) * 1 year ± 1 month (Clinical follow-up) * 3 years ± 6 months (Clinical follow-up) * 5 years ± 6 month (Clinical follow-up (optional) / Telephonic follow-up) * 10 years± 6 month (Clinical follow-up (optional) / Telephonic follow-up)

Detailed 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 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.

Conditions

• Knee Osteoarthritis
• Rheumatoid Arthritis
• Post-traumatic Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Freedom® Total Knee System	To evaluate the survivorship, safety and performance of the Freedom® Total Knee System in the treatment of subjects who in the surgeon's opinion require a primary total knee replacement due to severe knee joint pain and loss of mobility due to osteoarthritis, rheumatoid arthritis or post-traumatic arthritis.

Timeline

• Start date: 2021-01-01
• Primary completion: 2024-09-01
• Completion: 2032-09-01
• First posted: 2019-07-26
• Last updated: 2020-10-05

Regulatory

• FDA-regulated device study