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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A01565-40 | Other Identifier | 2023-A01565-40 |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| medial pivot polyethylene | Active Comparator | Total knee replacement with medial pivot polyethylene |
|
| ultra-congruent polyethylene | Active Comparator | Total knee replacement with ultra-congruent polyethylene |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| total knee arthroplasty with medial pivot polyethylene | Device | total knee arthroplasty with medial pivot polyethylene |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| knee joint mobility | Measurement of mobility in degrees (scale from 0 to 10) | Day -1 |
| knee joint mobility | Measurement of mobility in degrees (scale from 0 to 10) |
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Inclusion criteria :
Exclusion criteria :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | 334.73.754.963 | promo_interne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Stéphane DESCAMPS | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Recruiting | Clermont-Ferrand | France |
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Arm 1: Total knee replacement with medial pivot polyethylene
Arm 2: Total knee replacement with ultra-congruent polyethylene
| total knee arthroplasty with ultra-congruent polyethylene | Device | total knee arthroplasty with ultra-congruent polyethylene |
|
| Day 45 |
| knee joint mobility | Measurement of mobility in degrees (scale from 0 to 10) | month 12 |
| pain assessment | assessment with a numeric pain rating scale ranging from 0 (none) to 10 (severe pain) | Day -1 |
| pain assessment | assessment with a numeric pain rating scale ranging from 0 (none) to 10 (severe pain) | day 45 |
| pain assessment | assessment with a numeric pain rating scale ranging from 0 (none) to 10 (severe pain) | 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) | 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) | 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) | 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. | 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. | 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. | Month 12 |
| radiographic alignment | measurement of the anteroposterior radiographic alignment at 1 year post-operative using the Hip-knee-ankle (HKA) angle | 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°) | 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°) | 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°) | Month 12 |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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