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

NCT ID: NCT05509972

Last Updated: 2024-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-06

Study Completion Date

2024-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Columbus® DD Primary CoCr

Columbus® Deep Dish (DD) Primary Cobalt Chromium (CoCr)

total knee prosthesis implantation

Intervention Type DEVICE

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

Columbus® DD Primary CoCr AS coated

Columbus® Deep Dish (DD) Primary Cobalt Chromium (CoCr) Advanced Surface

total knee prosthesis implantation

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Columbus® Total Knee Arthroplasty

Eligibility Criteria

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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)
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Raylytic GmbH

INDUSTRY

Sponsor Role collaborator

Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitätsklinik Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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AAG-O-H-2024

Identifier Type: -

Identifier Source: org_study_id

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