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Clinical Trial Summary

Prospective, multi-centre, non-comparative, post-market surveillance clinical study


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03224689
Study type Interventional
Source Maxx Orthopedics Inc
Contact Robert Eberle
Phone +1 (919) 280-6900
Email robert.eberle@maxxortho.com
Status Recruiting
Phase N/A
Start date January 1, 2021
Completion date March 1, 2024

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