Gonarthrosis, Primary Knee Replacement, Total Knee Replacement
Conditions
Keywords
prospective, randomized study, parallel groups, forgotten joint score
Brief 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
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
DEVICEtotal knee arthroplasty with medial pivot polyethylene
total knee arthroplasty with medial pivot polyethylene
DEVICEtotal knee arthroplasty with ultra-congruent polyethylene
total knee arthroplasty with ultra-congruent polyethylene
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Arm 1: Total knee replacement with medial pivot polyethylene Arm 2: Total knee replacement with ultra-congruent polyethylene
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of the forgotten joint score (FJS12) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain assessment | Day -1 | assessment with a numeric pain rating scale ranging from 0 (none) to 10 (severe pain) |
| the Knee Society Score (KSS) | 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) |
| knee joint mobility | Day -1 | Measurement of mobility in degrees (scale from 0 to 10) |
| radiographic alignment | month 12 | measurement of the anteroposterior radiographic alignment at 1 year post-operative using the Hip-knee-ankle (HKA) angle |
| radiological complications | 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°) |
| Knee injury and Osteoarthritis Outcome Score Physical Function Short form (KOOS-PS). | day -1 | the KOOS-PS (free of charge) is used to assess the postoperative quality of life related to knee joint pathologies. |
Countries
France
Contacts
Primary ContactLise Laclautre
Outcome results
None listed