Evaluation of The Safety And Performance of The Freedom Total Knee® System With The PEEK-OPTIMA Femoral Component
Study Details
Study Description
Brief Summary
Prospective, multi-centre, non-comparative, post-market surveillance clinical study
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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:
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KSS Knee scores and KSS Function scores at 6 weeks, 6, 12 and 24 months post-treatment compared to pre-treatment
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Subject reported outcomes (SF-36, Oxford Knee Score and WOMAC) at 6 weeks, 6, 12 and 24 months post-treatment compared to pre-treatment
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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
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Safety in terms of adverse events and device deficiencies throughout the clinical investigation including any additional knee treatments and/or surgery
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Survivorship analysis of the device at 12 and 24 months and annually thereafter
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PEEK Femoral 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
TKA Surgery
|
Outcome Measures
Primary Outcome Measures
- Knee Society Score (KSS) [Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months]
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.
Secondary Outcome Measures
- Visual Analog Scale (VAS) [Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months]
Patient self administered overall satisfaction (scale from 1 worse -10 best)
- SF-36 [Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months]
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.
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) [Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months]
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
- Radiographic assessment [Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months]
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.
Eligibility Criteria
Criteria
INCLUSION CRITERIA:
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Male and female subjects aged 50 years of age or older and less than 75 years of age (>50 and <75 years).
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Subjects who require a uni-lateral knee prosthesis and have been evaluated as appropriate candidates for a total knee arthroplasty by the Investigator.
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Subjects with a primary diagnosis of end-stage symptomatic primary knee osteoarthritis
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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.
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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:
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Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
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Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
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Subjects who have participated in a clinical study with an investigational product in the last 6 months.
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Subjects with other significant disabling problems from the muscular-skeletal system other than in the knees (i.e muscular dystrophy, polio, neuropathic joints).
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Subjects with a BMI of 32 or above.
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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.
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Subjects with a primary or secondary diagnosis of inflammatory or traumatic arthritis.
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Subjects defined by the Investigator as ASA Grade III or IV.
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Subjects who have a neuromuscular or neurosensory deficit.
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Female subjects who are pregnant or lactating.
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Subjects with an anatomical limb alignment of above 20 degrees varus or valgus.
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Subjects with a fixed flexion deformity of over 20 degrees.
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Subjects with recurvatum (definition: hyperextension ≥ 5 degrees).
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | More Institue, Department of Orthopedic Surgery | Antwerp | Belgium |
Sponsors and Collaborators
- Maxx Orthopedics Inc
Investigators
- Principal Investigator: Peter Verdonk, MD, PhD, More Institute, Antwerp, Belgium
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MI-001