Clinical trial NCT05509972: In-vivo Wear Behaviour of AS Coated Versus Uncoated Columbus® Total Knee Prosthesis
Official title: International, Prospective, Longterm Study Comparing the Clinical Outcome and In-vivo Wear Behaviour of AS Coated Versus Uncoated Columbus® Total Knee Prosthesis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Knee Arthritis
Knee Osteoarthritis
Primary Osteoarthritis of Knee Nos
Secondary Osteoarthritis of Knee Nos
Rheumatoid Arthritis of Knee
Instability, Joint
Osteonecrosis
Deformity Knee
Keywords: Total Knee Arthroplasty
Implant Wear
Advanced Surface
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: Raylytic GmbH
First posted: 2022-08-22
Enrollment: 7
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited consecutively.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Polyethylene wear over time
timeFrame: until 10 years postoperatively
Secondary outcomes:
measure: Implant survival
timeFrame: until 10 years postoperatively
measure: Quality of Life [EQ-5D-5L] compared to baseline
timeFrame: preoperatively and 3 months, 12 months, 2 years, 5 years, 10 years postoperatively
measure: Progress of Clinical Outcome (Forgotten Joint Score-12) over follow-up period
timeFrame: 3 months, 12 months, 2 years, 5 years, 10 years postoperatively
measure: Progress of Clinical Outcome [Oxford Knee Score] compared to baseline
timeFrame: preoperatively and 3 months, 12 months, 2 years, 5 years, 10 years postoperatively
measure: Radiographic comparison of alignment over time
timeFrame: baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years
measure: Radiographic comparison of implant migration over time
timeFrame: baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years
measure: Radiographic comparison of tibial slope over time
timeFrame: baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years
measure: Radiographic comparison of the joint line over time
timeFrame: baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years
measure: Adverse events / serious adverse events
timeFrame: During the course of the study up to 10 years postoperatively
measure: Number of Participants with radiological complications over time
timeFrame: During the course of the study up to 10 years postoperatively
measure: Biomechanical analysis of retrievals in case of revision
timeFrame: During the course of the study up to 10 years postoperatively
Other outcomes:
measure: Baseline data
timeFrame: preoperatively
measure: Implant specifications
timeFrame: intraoperatively
measure: Surgery time
timeFrame: intraoperatively
measure: Axis Alignment data according to OrthoPilot® record
timeFrame: intraoperatively
Locations:
city: Freiburg
country: Germany
facility: Universitätsklinik Freiburg
state: Baden-Württemberg
Study officials:
References: