Comparison of Pivotal Medial Polyethylene Versus Ultra-congruent in Total Knee Arthroplasty
NCT ID: NCT06676189
Last Updated: 2025-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
90 participants
INTERVENTIONAL
2024-06-04
2027-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Highly Cross-Linked and Conventional Polyethylene in Total Knee Arthroplasty
NCT02020057
Highly Cross-linked Polyethylene in Total Knee Arthroplasty
NCT03622398
Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft (PopUp)
NCT00300690
Comparison of High Flex and Standard Rotating Platform Total Knee Arthroplasty (TKA)
NCT01176292
Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses
NCT04684160
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Over the years, patient expectations about the quality of life post-implantation continue to rise.
It is therefore essential to improve continuously surgical techniques and implants to fulfill patient expectations in terms of pain and movements.
The prosthetic device is composed of a metallic femoral unit, which imitates the articular surface of the femur, and a metallic tibial baseplate covered with a polyethylene (a highly resistant polymer) insert which articulates between the femur and the tibia. This insert can take several forms such as medial pivot or ultra-congruent.
This polymer provides an interface between the two metallic units forming the prothetic device. It has two roles: it provides a lasting contact surface and it offers stability to the knee in substitution of the ligaments.
In order to achieve this double function, a polyethylene system, called " medial pivot " was conceived.
This system mimics as close as possible the anatomical knee kinematics with a rotational movement that the " ball in socket " tries to reproduce by the mediatisation of the pivot point during knee flexion.
Currently, there are no randomized study which were conducted comparing these two types of polyethylene.
Total knee arthroplasty is usually effective at improving the quality of life of patients suffering from arthritis.
Over the years, patient expectations about the quality of life post-implantation continue to rise.
It is therefore essential to improve continuously surgical techniques and implants to fulfill patient expectations in terms of pain and movements.
The prosthetic device is composed of a metallic femoral unit, which imitates the articular surface of the femur, and a metallic tibial baseplate covered with a polyethylene (a highly resistant polymer) insert which articulates between the femur and the tibia. This insert can take several forms such as medial pivot or ultra-congruent.
This polymer provides an interface between the two metallic units forming the prothetic device. It has two roles: it provides a lasting contact surface and it offers stability to the knee in substitution of the ligaments.
In order to achieve this double function, a polyethylene system, called " medial pivot " was conceived.
This system mimics as close as possible the anatomical knee kinematics with a rotational movement that the " ball in socket " tries to reproduce by the mediatisation of the pivot point during knee flexion.
Currently, there are no randomized study which were conducted comparing these two types of polyethylene.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Arm 2: Total knee replacement with ultra-congruent polyethylene
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
medial pivot polyethylene
Total knee replacement with medial pivot polyethylene
total knee arthroplasty with medial pivot polyethylene
total knee arthroplasty with medial pivot polyethylene
ultra-congruent polyethylene
Total knee replacement with ultra-congruent polyethylene
total knee arthroplasty with ultra-congruent polyethylene
total knee arthroplasty with ultra-congruent polyethylene
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
total knee arthroplasty with medial pivot polyethylene
total knee arthroplasty with medial pivot polyethylene
total knee arthroplasty with ultra-congruent polyethylene
total knee arthroplasty with ultra-congruent polyethylene
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Competent subjects able to give informed consent to participate in the research
* Affiliation to the social security system
Exclusion Criteria
* Deformity greater than 15 degrees
* Any surgical and/or anesthetic contraindication, or any condition deemed by the investigator to be incompatible with the research.
* Any contraindication mentioned in the instructions for use of the medical device
* Pregnant or breastfeeding women
* Recent infection history of the surgical site
* Adults who are subject to a legal protection measure or who are unable to express their constent (Article L1121-8 of the French Public Health Code) and subjects under judicial protection (article L. 1122-2 FPHC)
* Subjects who refuse to participate
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stéphane DESCAMPS
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU de Clermont-Ferrand
Clermont-Ferrand, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Lise Laclautre
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-A01565-40
Identifier Type: OTHER
Identifier Source: secondary_id
RBHP 2023 DESCAMPS (MEPCAT)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.