Status:
NOT_YET_RECRUITING
Freedom® Total Knee System for Treatment of Osteoarthritis, Rheumatoid Arthritis or Post-traumatic Arthritis
Lead Sponsor:
Meril Life Sciences Pvt. Ltd.
Conditions:
Knee Osteoarthritis
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 approximat...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2032
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04033588
Start Date
January 1 2021
End Date
September 1 2032
Last Update
October 5 2020
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