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

NCT05509972 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 7

Last updated 2024-10-09

No results posted yet for this study

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.

Conditions

  • Knee Arthritis
  • Knee Osteoarthritis
  • Primary Osteoarthritis of Knee Nos
  • Secondary Osteoarthritis of Knee Nos
  • Rheumatoid Arthritis of Knee
  • Instability, Joint
  • Osteonecrosis
  • Deformity Knee

Interventions

DEVICE

total knee prosthesis implantation

Total Knee Arthroplasty (TKA) represents a well-established, reliable and successful treatment option for end-stage bicompartmental osteoarthritis or comparable conditions even in young patients compromised by knee pain and limitations of daily living

Sponsors & Collaborators

  • Raylytic GmbH

    collaborator INDUSTRY

  • Aesculap AG

    lead INDUSTRY

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-06
Primary Completion
2024-02-01
Completion
2024-08-30

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05509972 on ClinicalTrials.gov