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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05509972




Registration number
NCT05509972
Ethics application status
Date submitted
11/08/2022
Date registered
22/08/2022
Date last updated
14/08/2023

Titles & IDs
Public title
In-vivo Wear Behaviour of AS Coated Versus Uncoated Columbus® Total Knee Prosthesis
Scientific title
International, Prospective, Longterm Study Comparing the Clinical Outcome and In-vivo Wear Behaviour of AS Coated Versus Uncoated Columbus® Total Knee Prosthesis
Secondary ID [1] 0 0
AAG-O-H-2024
Universal Trial Number (UTN)
Trial acronym
COLRAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Arthritis 0 0
Knee Osteoarthritis 0 0
Primary Osteoarthritis of Knee Nos 0 0
Secondary Osteoarthritis of Knee Nos 0 0
Rheumatoid Arthritis of Knee 0 0
Instability, Joint 0 0
Osteonecrosis 0 0
Deformity Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - total knee prosthesis implantation

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

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


Treatment: Devices: 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 code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Polyethylene wear over time
Timepoint [1] 0 0
until 10 years postoperatively
Secondary outcome [1] 0 0
Implant survival
Timepoint [1] 0 0
until 10 years postoperatively
Secondary outcome [2] 0 0
Quality of Life [EQ-5D-5L] compared to baseline
Timepoint [2] 0 0
preoperatively and 3 months, 12 months, 2 years, 5 years, 10 years postoperatively
Secondary outcome [3] 0 0
Progress of Clinical Outcome (Forgotten Joint Score-12) over follow-up period
Timepoint [3] 0 0
3 months, 12 months, 2 years, 5 years, 10 years postoperatively
Secondary outcome [4] 0 0
Progress of Clinical Outcome [Oxford Knee Score] compared to baseline
Timepoint [4] 0 0
preoperatively and 3 months, 12 months, 2 years, 5 years, 10 years postoperatively
Secondary outcome [5] 0 0
Radiographic comparison of alignment over time
Timepoint [5] 0 0
baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years
Secondary outcome [6] 0 0
Radiographic comparison of implant migration over time
Timepoint [6] 0 0
baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years
Secondary outcome [7] 0 0
Radiographic comparison of tibial slope over time
Timepoint [7] 0 0
baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years
Secondary outcome [8] 0 0
Radiographic comparison of the joint line over time
Timepoint [8] 0 0
baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years
Secondary outcome [9] 0 0
Adverse events / serious adverse events
Timepoint [9] 0 0
During the course of the study up to 10 years postoperatively
Secondary outcome [10] 0 0
Number of Participants with radiological complications over time
Timepoint [10] 0 0
During the course of the study up to 10 years postoperatively
Secondary outcome [11] 0 0
Biomechanical analysis of retrievals in case of revision
Timepoint [11] 0 0
During the course of the study up to 10 years postoperatively

Eligibility
Key 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
Minimum age
45 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnancy

- Patient age <45 and >75years

- Acute inflammatory arthritis

- Coagulation disorders (e.g. Haemophilia)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2034
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Lakeview Private Hospital Orthopaedics - Bella Vista
Recruitment postcode(s) [1] 0 0
2153 - Bella Vista
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Baden-Württemberg

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Aesculap AG
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Raylytic GmbH
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05509972
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Marius Selig
Address 0 0
Country 0 0
Phone 0 0
+49746195
Fax 0 0
Email 0 0
info@aesculap.de
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05509972