CHU de Clermont-Ferrand
Clermont-Ferrand, France
Location status: Recruiting
Location contact
Lise Laclautre
CONTACT
Stéphane DESCAMPS
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06676189
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
Interested in participating?
Request Info18 year–90 year
All sexes
Interventional
Not applicable
Clermont-Ferrand, France
Location status: Recruiting
Lise Laclautre
CONTACT
Stéphane DESCAMPS
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
total knee arthroplasty with medial pivot polyethylene
total knee arthroplasty with ultra-congruent polyethylene
Time frame: Day 45
Forgotten knee score at 6 weeks (FJS-12, evaluated out of 100), which allows the analysis of quality of life specifically in relation to knee pathologies
Time frame: Month 12
Forgotten knee score at 6 weeks (FJS-12, evaluated out of 100), which allows the analysis of quality of life specifically in relation to knee pathologies
Time frame: Day -1
Measurement of mobility in degrees (scale from 0 to 10)
Time frame: Day 45
Measurement of mobility in degrees (scale from 0 to 10)
Time frame: month 12
Measurement of mobility in degrees (scale from 0 to 10)
Time frame: Day -1
assessment with a numeric pain rating scale ranging from 0 (none) to 10 (severe pain)
Time frame: day 45
assessment with a numeric pain rating scale ranging from 0 (none) to 10 (severe pain)
Time frame: month 12
assessment with a numeric pain rating scale ranging from 0 (none) to 10 (severe pain)
Time frame: Day -1
the KSS (free of charge) scoring system is divided into 2 subcategories: a clinical score (maximum of 100 points) and a functional score (maximum of 100 points)
Time frame: Day 45
the KSS (free of charge) scoring system is divided into 2 subcategories: a clinical score (maximum of 100 points) and a functional score (maximum of 100 points)
Time frame: month 12
the KSS (free of charge) scoring system is divided into 2 subcategories: a clinical score (maximum of 100 points) and a functional score (maximum of 100 points)
Time frame: day -1
the KOOS-PS (free of charge) is used to assess the postoperative quality of life related to knee joint pathologies.
Time frame: Day 45
the KOOS-PS (free of charge) is used to assess the postoperative quality of life related to knee joint pathologies.
Time frame: Month 12
the KOOS-PS (free of charge) is used to assess the postoperative quality of life related to knee joint pathologies.
Time frame: month 12
measurement of the anteroposterior radiographic alignment at 1 year post-operative using the Hip-knee-ankle (HKA) angle
Time frame: Day -1
Peri- and post-operative complications using standard radiographic analysis (static radiographs of the lower limbs, anteroposterior and lateral knee radiographs, patellofemoral view at 45°)
Time frame: Day 45
Peri- and post-operative complications using standard radiographic analysis (static radiographs of the lower limbs, anteroposterior and lateral knee radiographs, patellofemoral view at 45°)
Time frame: Month 12
Peri- and post-operative complications using standard radiographic analysis (static radiographs of the lower limbs, anteroposterior and lateral knee radiographs, patellofemoral view at 45°)
Contact information is provided by the study sponsor or research team.
University Hospital, Clermont-Ferrand
Other
Acronym: MEPCAT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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