NCT03224689

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Maxx Orthopedics Inc · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

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

Conditions

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

Interventions

Type	Name	Description
DEVICE	PEEK-Optima Femoral Component	TKA Surgery

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-12-31
• Completion: 2024-03-01
• First posted: 2017-07-21
• Last updated: 2021-07-15

Locations

1 site across 1 country: Belgium