A Multi-Centre Clinical Investigation To Evaluate The Safety And Performance Of The Freedom Total Knee® System With The PEEK-OPTIMA Femoral Component
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Maxx Orthopedics Inc
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Knee Society Score (KSS)
- Last Updated
- 4 years ago
Overview
Brief Summary
Prospective, multi-centre, non-comparative, post-market surveillance clinical study
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: * 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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Knee Society Score (KSS)
Time Frame: 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 Outcomes
- SF-36(Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months)
- Western Ontario and McMaster Universities Arthritis Index (WOMAC)(Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months)
- Visual Analog Scale (VAS)(Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months)
- Radiographic assessment(Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months)