Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05509972
Other study ID # AAG-O-H-2024
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 6, 2023
Est. completion date June 2034

Study information

Verified date August 2023
Source Aesculap AG
Contact Marius Selig
Phone +49746195
Email info@aesculap.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date June 2034
Est. primary completion date February 2024
Accepts healthy volunteers No
Gender All
Age group 45 Years to 75 Years
Eligibility Inclusion Criteria: - Indication for a primary bicondylar total knee endoprosthesis with the ColumbusĀ® 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)

Study Design


Intervention

Device:
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

Locations

Country Name City State
Australia Lakeview Private Hospital Orthopaedics Bella Vista New South Wales
Germany Universitätsklinik Freiburg Freiburg Baden-Württemberg

Sponsors (2)

Lead Sponsor Collaborator
Aesculap AG Raylytic GmbH

Countries where clinical trial is conducted

Australia,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Baseline data Demographics and medical history preoperatively
Other Implant specifications The size and material of each component (tibial and femoral implant, liners, patella resurfacing) of the used implant are documented. intraoperatively
Other Surgery time the Surgery time from first cut to wound closure is documented intraoperatively
Other Axis Alignment data according to OrthoPilot® record The orthopaedic navigation system AESCULAPĀ® OrthoPilotĀ® 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. intraoperatively
Primary Polyethylene wear over time 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. until 10 years postoperatively
Secondary Implant survival Kaplan-Meier Analysis is a standard statistical method to describe the survival of human subjects or medical products over a defined time period. until 10 years postoperatively
Secondary Quality of Life [EQ-5D-5L] compared to baseline 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.
preoperatively and 3 months, 12 months, 2 years, 5 years, 10 years postoperatively
Secondary Progress of Clinical Outcome (Forgotten Joint Score-12) over follow-up period 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 3 months, 12 months, 2 years, 5 years, 10 years postoperatively
Secondary Progress of Clinical Outcome [Oxford Knee Score] compared to baseline 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, preoperatively and 3 months, 12 months, 2 years, 5 years, 10 years postoperatively
Secondary Radiographic comparison of alignment over time 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 baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years
Secondary Radiographic comparison of implant migration over time 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, baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years
Secondary Radiographic comparison of tibial slope over time 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 baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years
Secondary Radiographic comparison of the joint line over time 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 baseline (assessed at discharge from hospital up to 10 days postoperatively); 3 months; 12 months; 5 years; 10 years
Secondary Adverse events / serious adverse events 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 During the course of the study up to 10 years postoperatively
Secondary Number of Participants with radiological complications over time 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.
During the course of the study up to 10 years postoperatively
Secondary Biomechanical analysis of retrievals in case of revision 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. During the course of the study up to 10 years postoperatively
See also
  Status Clinical Trial Phase
Recruiting NCT04651673 - Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
Completed NCT05677399 - Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise. N/A
Active, not recruiting NCT04043819 - Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis Phase 1
Recruiting NCT06000410 - A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee Phase 3
Completed NCT05014542 - Needling Techniques for Knee Osteoarthritis N/A
Recruiting NCT05892133 - Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty N/A
Recruiting NCT05528965 - Parallel Versus Perpendicular Technique for Genicular Radiofrequency N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Active, not recruiting NCT02003976 - A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone N/A
Active, not recruiting NCT04017533 - Stability of Uncemented Medially Stabilized TKA N/A
Completed NCT04779164 - The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis N/A
Recruiting NCT04006314 - Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis N/A
Recruiting NCT05423587 - Genicular Artery Embolisation for Knee Osteoarthritis II N/A
Enrolling by invitation NCT04145401 - Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
Active, not recruiting NCT03781843 - Effects of Genicular Nerve Block in Knee Osteoarthritis N/A
Completed NCT05974501 - Pre vs Post Block in Total Knee Arthroplasty (TKA) Phase 4
Completed NCT05324163 - Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis Phase 3
Completed NCT05529914 - Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis N/A
Recruiting NCT05693493 - Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA? N/A
Not yet recruiting NCT05510648 - Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis N/A