evaluation of the safety and performance of the freedom total knee® system with the peek-optima femoral component

Conditions: Osteoarthritis, Knee; Rheumatoid Arthritis of Knee; Traumatic Arthritis of Knee (Diagnosis); Polyarthritis; Fractures, Bone

Summary: prospective, multi-centre, non-comparative, post-market surveillance clinical study

primary endpoint: * the primary endpoint is to evaluate the procedural success ie successful implantation of the device in the opinion of the surgeon secondary endpoints: the secondary endpoints are to evaluate: * kss knee scores and kss function scores at 6 weeks, 6, 12 and 24 months post-treatment compared to pre-treatment * subject reported outcomes (sf-36, oxford knee score and womac) at 6 weeks, 6, 12 and 24 months post-treatment compared to pre-treatment * stability of the device through radiographic analysis to assess alignment and component position at immediate post-treatment, 6 weeks, 6, 12 and 24 months post-treatment * safety in terms of adverse events and device deficiencies throughout the clinical investigation including any additional knee treatments and/or surgery * survivorship analysis of the device at 12 and 24 months and annually thereafter

Eligibility criteria:
inclusion criteria: * male and female subjects aged 50 years of age or older and less than 75 years of age (\>50 and \<75 years). * subjects who require a uni-lateral knee prosthesis and have been evaluated as appropriate candidates for a total knee arthroplasty by the investigator. * subjects with a primary diagnosis of end-stage symptomatic primary knee 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 abusers or with psychological disorders that could affect follow-up care or treatment outcomes. * subjects who have participated in a clinical study with an investigational product in the last 6 months. * 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 32 or above. * subjects with a current or active history of malignancy, active or suspected infection, paget's disease, renal osteodystrophy, immunologically suppressed, rheumatoid arthritis, sickle cell anemia, and systemic lupus erythematosus. * subjects with a primary or secondary diagnosis of inflammatory or traumatic arthritis. * subjects defined by the investigator as asa grade iii or iv. * subjects who have a neuromuscular or neurosensory deficit. * female subjects who are pregnant or lactating. * subjects with an anatomical limb alignment of above 20 degrees varus or valgus. * subjects with a fixed flexion deformity of over 20 degrees. * subjects with recurvatum (definition: hyperextension ≥ 5 degrees). * subjects who have previously undergone total or unicondylar knee arthroplasty, high tibial osteotomy, ligament reconstruction, orif or with previous fracture in the ipsilateral knee joint.