Comparison of Pivotal Medial Polyethylene Versus Ultra-congruent in Total Knee Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: total knee arthroplasty with medial pivot polyethylene, total knee arthroplasty with ultra-congruent polyethylene.
- Who it may be relevant to
- Registry conditions: Total Knee Replacement, Primary Knee Replacement, Gonarthrosis. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The aim of this study is to compare the forgotten joint score for the medial pivot polyethylene and ultra-congruent polyethylene which are used in total prosthetic replacement of the knee
Detailed description
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.
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.
Interventions
- Device total knee arthroplasty with medial pivot polyethylene
total knee arthroplasty with medial pivot polyethylene - Device total knee arthroplasty with ultra-congruent polyethylene
total knee arthroplasty with ultra-congruent polyethylene
Primary outcome measures
- evaluation of the forgotten joint score (FJS12) [Time frame: Day 45]
- evaluation of the forgotten joint score (FJS12) [Time frame: Month 12]
Secondary outcome measures (12)
- knee joint mobility [Time frame: Day -1]
- knee joint mobility [Time frame: Day 45]
- knee joint mobility [Time frame: month 12]
- pain assessment [Time frame: Day -1]
- pain assessment [Time frame: day 45]
- pain assessment [Time frame: month 12]
- the Knee Society Score (KSS) [Time frame: Day -1]
- the Knee Society Score (KSS) [Time frame: Day 45]
- the Knee Society Score (KSS) [Time frame: month 12]
- Knee injury and Osteoarthritis Outcome Score Physical Function Short form (KOOS-PS). [Time frame: day -1]
- Knee injury and Osteoarthritis Outcome Score Physical Function Short form (KOOS-PS). [Time frame: Day 45]
- Knee injury and Osteoarthritis Outcome Score Physical Function Short form (KOOS-PS). [Time frame: Month 12]
Eligibility criteria
Inclusion criteria
- Subjects 18 to 90 years of age, eligible for a primary total knee replacement for gonarthrosis
- Competent subjects able to give informed consent to participate in the research
- Affiliation to the social security system
Exclusion criteria
- Infection history of the knee to be replaced
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU de Clermont-Ferrand — Clermont-Ferrand
Identifiers
NCT: NCT06676189 · RBHP 2023 DESCAMPS (MEPCAT) · 2023-A01565-40