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NOT YET RECRUITING

NCT04033588

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

Sponsor: Meril Life Sciences Pvt. Ltd.

View on ClinicalTrials.gov

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)

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2021-01-01

Completion Date

2032-09-01

Last Updated

2020-10-05

Healthy Volunteers

Conditions

Knee Osteoarthritis Rheumatoid Arthritis Post-traumatic Osteoarthritis

Interventions

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.

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.