Deformity Knee, Instability, Joint, Knee Arthritis, Knee Osteoarthritis, Osteonecrosis, Primary Osteoarthritis of Knee Nos, Rheumatoid Arthritis of Knee, Secondary Osteoarthritis of Knee Nos
Conditions
Keywords
Total Knee Arthroplasty, Implant Wear, Advanced Surface
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.
Interventions
DEVICEtotal 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
Raylytic GmbH
Aesculap AG
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Polyethylene wear over time | until 10 years postoperatively | The in-vivo wear of the Polyethylene (PE) tibial tray will be assessed using the observer independent method of the imaging core lab. The PE wear assessment is based on the absolute object position of the knee prosthesis over time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic comparison of alignment over time | baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years | Radiographs shall be standardized between centres as far as possible. Unless limited by patient or equipment constraints, all follow-up imaging examinations will be obtained according to the radiographic protocol of the hospital and the set routine. The radiographic evaluation of Alignment combines Hip-Knee-Angle, femoral and tibial component alignment |
| Radiographic comparison of the joint line over time | baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years | Radiographs shall be standardized between centres as far as possible. Unless limited by patient or equipment constraints, all follow-up imaging examinations will be obtained according to the radiographic protocol of the hospital and the set routine. Any changes of the joint line over the follow-up period is documented in the radiographic evaluation |
| Adverse events / serious adverse events | During the course of the study up to 10 years postoperatively | During the course of the study, any upcoming intra- or postoperative (serious) adverse events (AE / SAE) or device effects related or not related to the product under investigation or the procedure, will be documented in the dedicated Case Report Forms. The total number of AEs will be summarized and further evaluated by the sponsor and reported according to local legislation and necessity. Recorded complications will be categorized and analyzed in order to assess the safety of the investigational product |
| Number of Participants with radiological complications over time | During the course of the study up to 10 years postoperatively | Radiographs shall be standardized between centres as far as possible. Unless limited by patient or equipment constraints, all follow-up imaging examinations will be obtained according to the radiographic protocol of the hospital and the set routine. All radiologically evident complications (including fracture, wear, loosening or radiolucencies) are cumulatively documented over the period of follow-up. |
| Biomechanical analysis of retrievals in case of revision | During the course of the study up to 10 years postoperatively | Available retrievals of explanted investigational products will be analysed by the biomechanical laboratory of the sponsor according to an analysis protocol which includes the oxidation profile, the wear behaviour, the mechanics and the cumulative linear abrasion of these retrievals. |
| Implant survival | until 10 years postoperatively | Kaplan-Meier Analysis is a standard statistical method to describe the survival of human subjects or medical products over a defined time period. |
| Quality of Life [EQ-5D-5L] compared to baseline | preoperatively and 3 months, 12 months, 2 years, 5 years, 10 years postoperatively | The 5-dimension 5-level measure of the health status, developed by the EuroQol Group (EQ-5D-5L) is a simple and generic measure for clinical and economic assessment. Instructions for the user are directly included into the questionnaire and it consists of two pages. One cover five different dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and the other one the EQ visual Analogue Scale (EQ-VAS). The VAS scale records the self rated health status of the patient from the level the worst health you can imagine to the best health you can imagine. The answer of each of the five dimensions result in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. |
| Progress of Clinical Outcome (Forgotten Joint Score-12) over follow-up period | 3 months, 12 months, 2 years, 5 years, 10 years postoperatively | The Forgotten Joint Score-12 (FJS-12) Knee was designed to assess patient outcome in patients undergoing conservative or operative treatment of the knee. These Patient Reported Outcome (PRO) questionnaires focus on patients' awareness of a specific joint in everyday life. In 12 Items the awareness for the artificial joint is assessed by the patient, each on a five point scale (Never / Almost Never / Seldom / Sometimes / Mostly) The Forgotten Joint Score assessment consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities |
| Progress of Clinical Outcome [Oxford Knee Score] compared to baseline | preoperatively and 3 months, 12 months, 2 years, 5 years, 10 years postoperatively | The Oxford Knee Score (OKS) is a reliable 12-item, patient-reported questionnaire originally developed and validated specifically to assess function and pain in patients undergoing total knee replacement. It is short, reproducible, valid and sensitive to clinically important changes over time. Each of the 12 questions on the OKS is scored in the same way with the score decreasing as the reported symptoms increase (i.e. become worse). All questions are laid out with response categories denoting least (or no) symptoms to the left of the page (scoring 4) and those representing greatest severity lying on the right hand side (scoring 0), as detailed for question 1 below. This method, when summed, produces overall scores running from 0 to 48 with 48 being the best outcome, |
| Radiographic comparison of implant migration over time | baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years | Radiographs shall be standardized between centres as far as possible. Unless limited by patient or equipment constraints, all follow-up imaging examinations will be obtained according to the radiographic protocol of the hospital and the set routine. The radiographic evaluation of implant migration comprises tibial and femoral components in m/l and a/p direction, |
| Radiographic comparison of tibial slope over time | baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years | Radiographs shall be standardized between centres as far as possible. Unless limited by patient or equipment constraints, all follow-up imaging examinations will be obtained according to the radiographic protocol of the hospital and the set routine. Any changes of Tibial slope over the follow-up period is documented in the radiographic evaluation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Implant specifications | intraoperatively | The size and material of each component (tibial and femoral implant, liners, patella resurfacing) of the used implant are documented. |
| Surgery time | intraoperatively | the Surgery time from first cut to wound closure is documented |
| Axis Alignment data according to OrthoPilot® record | intraoperatively | The orthopaedic navigation system AESCULAP® OrthoPilot® Elite is based on 25 years of experience. During the navigated surgery a record with data on intraoperatively achieved alignment / joint line restoration is stored. |
| Baseline data | preoperatively | Demographics and medical history |
Countries
Germany
Outcome results
None listed