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)
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, 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).
Single group
Freedom® Total Knee System
DeviceTo 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.
Implant Survivorship Kaplan-Meier estimates of survivorship for all components
Implant survivor-ship will be established by using revision surgery on the operated knee as implant failure.
Oxford Knee Score which consists of 12 questions
Oxford Knee Score is a patient-reported validated outcome measure scoring from 0 - 48. It consists of 12 questions related to patient's own perception of pain and function in the knee being evaluated. Higher the score better the functioning of the knee.
Range of Motion using a standard goniometer
Range of motion will be assessed using a standard goniometer. It will measure the angle between maximum extension and maximum flexion that a patient can achieve in the operated knee.
Knee Society Score
This score consists of points given for pain, range of motion, and stability. It Consists of points given for the ability to walk on level surfaces, and the ability to ascend and descend stairs.Score range of the KSS is from 0 to 100 points for each portion, with higher scores indicating better outcome
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