TerminatedNot Applicable

In-vivo Wear Behaviour of AS Coated Versus Uncoated Columbus® Total Knee Prosthesis

Stopped: Recruitment too slow

Germany7 participantsStarted 2023-04-06

Plain-language summary

This clinical study is a Post-Market Clinical Follow-Up (PMCF) measure and is aiming to compare the in-vivo wear behaviour of the Columbus® total knee prosthesis between the standard Cobalt Chromium (CoCr) and the multilayer coated so called "Advanced Surface" (AS) of the same implant. The clinical investigation is designed as a International, prospective, longterm non-interventional study in order to gain clinical data of many patients within the routine clinical application of the investigational device.

Who can participate

Age range45 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Indication for a primary bicondylar total knee endoprosthesis with the Columbus® DD knee prosthesis * Written signed informed consent of patient * Willingness and mental ability to participate at the long-term follow-up examinations Exclusion Criteria: * Pregnancy * Patient age \<45 and \>75years * Acute inflammatory arthritis * Coagulation disorders (e.g. Haemophilia)

What they're measuring

Polyethylene wear over time

Timeframe: until 10 years postoperatively

Trial details

NCT IDNCT05509972

SponsorAesculap AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-02-01

View on ClinicalTrials.gov More Knee Arthritis trials