Evaluation of The Safety And Performance of The Freedom Total Knee® System With The PEEK-OPTIMA Femoral Component

Study Overview
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Brief Summary
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Prospective, multi-centre, non-comparative, post-market surveillance clinical study

Detailed Description
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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

Official Title
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A Multi-Centre Clinical Investigation To Evaluate The Safety And Performance Of The Freedom Total Knee® System With The PEEK-OPTIMA Femoral Component

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

Intervention / Treatment
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* Device: PEEK-Optima Femoral Component


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEEK Femoral<br>Subjects with a primary diagnosis of end-stage symptomatic primary knee osteoarthritis who require a uni-lateral knee prosthesis and have been evaluated as appropriate candidates for a total knee arthroplasty by the Investigator will be invited to take part in this clinical investigation. | Device: PEEK-Optima Femoral Component<br>* TKA Surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score (KSS) | Pre-and post-operative function and patient and mechanical assessment. The KSS contains questions in 2 sections: knee joint (pain, range of motion, stability) and function (walking distance, ability to climb stairs). The greater score correlates to better outcome. | Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) | Patient self administered overall satisfaction (scale from 1 worse -10 best) | Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months | 
| SF-36 | Assessment domains to explain variations in patient outcomes. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months | 
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) | Assessment of OA of the knee or hip. Possible score range of 0- 20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function | Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months | 
| Radiographic assessment | Subjective review and assessment of serial radiographs. Items include presence or absence of radiographic evidence of component loosening, malposition, migration and periprosthetic osteolysis, bone loss or interface composite (bone-cement-component) breakdown. | Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months |