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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMeril Life Sciences Pvt. Ltd.

About this trial

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)

Eligibility criteria

Qualifiers

Male and female subjects aged between 18 years and 75 years.

Subjects who require unilateral knee prosthesis and have been evaluated as appropriate candidates for a total knee replacement by the investigator.

Subjects suffering from severe knee joint pain and loss of mobility due to rheumatoid arthritis, osteoarthritis or post-traumatic osteoarthritis.

Subjects, who in the opinion of the investigator are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow ups.

Disqualifiers

Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.

Subjects who are known drug or alcohol abuse or with psychological disorders that could affect follow-up care or treatment outcomes.

Subject with a known sensitivity to device materials.

Subjects with other significant disabling problems from the muscular-skeletal system other than in the knees (i.e muscular dystrophy, polio, neuropathic joints).

Trial design

Treatments tested in this trial

  • Freedom® Total Knee System

Treatment groups

450 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators