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

Launched by MERIL LIFE SCIENCES PVT. LTD. · Jul 24, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the Freedom® Total Knee System, which is a type of artificial knee joint, to see how well it works for people suffering from severe knee pain and movement issues caused by conditions like osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis. The goal is to gather information about the safety and long-term performance of this knee replacement system in about 450 participants across various centers in the UK.

To be eligible for the trial, participants need to be between 18 and 75 years old and must require a knee replacement due to severe pain and loss of mobility. They should be able to understand the study and agree to return for several follow-up appointments after the surgery, which will happen at 6-8 weeks, 1 year, 3 years, and optionally at 5 and 10 years. This study is not currently recruiting participants, but it's important for those interested in future options to know the criteria and what to expect in terms of follow-ups and care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
• Exclusion Criteria:
• • 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).
• • Subjects with a BMI of 40 or above.
• • Subjects with a current or active history of malignancy, active or suspected infection, Paget's disease, renal osteodystrophy, immunologically suppressed or have any other significant medical illness judged by investigator to exclude from study.
• • Subject with neuromuscular or neurosensory deficiency that may limit ability of the patient to evaluate the safety and efficacy of the device.
• • Female subjects who are pregnant or lactating.
• • Subjects who have previously undergone total or unicondylar knee replacement, high tibial osteotomy, ligament reconstruction, open reduction internal fixation (ORIF) or with previous fracture in the ipsilateral knee joint.