Total Knee ReplacementMEPCATNCT06676189
Comparison of Pivotal Medial Polyethylene Versus Ultra-congruent in Total Knee Arthroplasty
A study testing total knee arthroplasty with medial pivot polyethylene and total knee arthroplasty with ultra-congruent polyethylene in people with Total Knee Replacement and Primary Knee Replacement, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Total Knee Replacement, Primary Knee Replacement, Gonarthrosis
- What is being tested?
- total knee arthroplasty with medial pivot polyethylene and total knee arthroplasty with ultra-congruent polyethylene
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jun 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand
Lise Laclautre
Stéphane DESCAMPS
About this study
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
Read the 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.
- Being tested
- total knee arthroplasty with medial pivot polyethylene, total knee arthroplasty with ultra-congruent polyethylene
- Keywords
- prospective, randomized study, parallel groups, forgotten joint score
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total knee arthroplasty with medial pivot polyethyleneDevice
total knee arthroplasty with medial pivot polyethylene
total knee arthroplasty with ultra-congruent polyethyleneDevice
total knee arthroplasty with ultra-congruent polyethylene
| Study group | Role | What they receive |
|---|---|---|
| medial pivot polyethylene | Active comparator | Total knee replacement with medial pivot polyethylene Receives: Device: total knee arthroplasty with medial pivot polyethylene |
| ultra-congruent polyethylene | Active comparator | Total knee replacement with ultra-congruent polyethylene Receives: Device: total knee arthroplasty with ultra-congruent polyethylene |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the forgotten joint score (FJS12)
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
Measured: Day 45
evaluation of the forgotten joint score (FJS12)
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
Measured: Month 12
Secondary outcomes (16)
knee joint mobility
Measurement of mobility in degrees (scale from 0 to 10)
Measured: Day -1
knee joint mobility
Measurement of mobility in degrees (scale from 0 to 10)
Measured: Day 45
knee joint mobility
Measurement of mobility in degrees (scale from 0 to 10)
Measured: month 12
pain assessment
assessment with a numeric pain rating scale ranging from 0 (none) to 10 (severe pain)
Measured: Day -1
pain assessment
assessment with a numeric pain rating scale ranging from 0 (none) to 10 (severe pain)
Measured: day 45
pain assessment
assessment with a numeric pain rating scale ranging from 0 (none) to 10 (severe pain)
Measured: month 12
the Knee Society Score (KSS)
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)
Measured: Day -1
the Knee Society Score (KSS)
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)
Measured: Day 45
the Knee Society Score (KSS)
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)
Measured: month 12
Knee injury and Osteoarthritis Outcome Score Physical Function Short form (KOOS-PS).
the KOOS-PS (free of charge) is used to assess the postoperative quality of life related to knee joint pathologies.
Measured: day -1
Knee injury and Osteoarthritis Outcome Score Physical Function Short form (KOOS-PS).
the KOOS-PS (free of charge) is used to assess the postoperative quality of life related to knee joint pathologies.
Measured: Day 45
Knee injury and Osteoarthritis Outcome Score Physical Function Short form (KOOS-PS).
the KOOS-PS (free of charge) is used to assess the postoperative quality of life related to knee joint pathologies.
Measured: Month 12
radiographic alignment
measurement of the anteroposterior radiographic alignment at 1 year post-operative using the Hip-knee-ankle (HKA) angle
Measured: month 12
radiological complications
Peri- and post-operative complications using standard radiographic analysis (static radiographs of the lower limbs, anteroposterior and lateral knee radiographs, patellofemoral view at 45°)
Measured: Day -1
radiological complications
Peri- and post-operative complications using standard radiographic analysis (static radiographs of the lower limbs, anteroposterior and lateral knee radiographs, patellofemoral view at 45°)
Measured: Day 45
radiological complications
Peri- and post-operative complications using standard radiographic analysis (static radiographs of the lower limbs, anteroposterior and lateral knee radiographs, patellofemoral view at 45°)
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start4 Jun 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane DESCAMPS, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676189
- Sponsor's protocol ID
- RBHP 2023 DESCAMPS (MEPCAT)
- Other IDs
- 2023-A01565-40
- Acronym
- MEPCAT
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pivotal Medial Polyethylene Versus Ultra-congruent in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06676189
- Acronym / sponsor ID
- MEPCAT / RBHP 2023 DESCAMPS (MEPCAT)
- Keywords
- prospective, randomized study, parallel groups, forgotten joint score
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| medial pivot polyethylene | Active comparator | Device: total knee arthroplasty with medial pivot polyethyleneTotal knee replacement with medial pivot polyethylene |
| ultra-congruent polyethylene | Active comparator | Device: total knee arthroplasty with ultra-congruent polyethyleneTotal knee replacement with ultra-congruent polyethylene |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total knee arthroplasty with medial pivot polyethylenetotal knee arthroplasty with medial pivot polyethylene | Device | medial pivot polyethylene |
| total knee arthroplasty with ultra-congruent polyethylenetotal knee arthroplasty with ultra-congruent polyethylene | Device | ultra-congruent polyethylene |
Primary outcome
evaluation of the forgotten joint score (FJS12)
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
evaluation of the forgotten joint score (FJS12)
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
16 secondary outcomes
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
radiographic alignment
Time frame: month 12
radiological complications
Time frame: Day -1
radiological complications
Time frame: Day 45
radiological complications
Time frame: Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stéphane DESCAMPS principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total knee arthroplasty with medial pivot polyethylene and total knee arthroplasty with ultra-congruent polyethylene in people with Total Knee Replacement and Primary Knee Replacement, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of the forgotten joint score (FJS12) (time frame: Day 45). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.