In-vivo Wear Behaviour of AS Coated Versus Uncoated Columbus® Total Knee Prosthesis
Key facts
- Who runs it
- Aesculap AG
- Where
- Germany1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 7 people enrolled
- Started
- 6 Apr 2023
- Ended
- 30 Aug 2024
- Type of study
- Observational, 2 groups
- Treatments tested
- total knee prosthesis implantation
- Record updated
- 9 October 2024
- Why it stopped
- Recruitment too slow
Who can take part
- Age
- 45 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- Coagulation disorders (e.g. Haemophilia)
- Patient age <45 and >75years
- Pregnancy
- Acute inflammatory arthritis
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Columbus® DD Primary CoCr
Columbus® Deep Dish (DD) Primary Cobalt Chromium (CoCr)
Treatment: total knee prosthesis implantation
- Columbus® DD Primary CoCr AS coated
Columbus® Deep Dish (DD) Primary Cobalt Chromium (CoCr) Advanced Surface
Treatment: total knee prosthesis implantation
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- International, Prospective, Longterm Study Comparing the Clinical Outcome and In-vivo Wear Behaviour of AS Coated Versus Uncoated Columbus® Total Knee Prosthesis
- Record updated
- 9 October 2024