Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A00075-34 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main objective of this study is to evaluate the benefit of personalized prostheses compared to conventional prostheses on patient satisfaction 24 months after total knee arthroplasty.
Prospective randomized monocentric prospective comparative study carried out as a single blind study on two parallel groups (standard implant or customized implant).
Secondary Objectives: Compare between groups :
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard implant | arthroplasty with a standard implant |
| |
| personalized implant | arthroplasty with a customized implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arthroplasty | Procedure | total knee replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| IKS self-questionnaire Score at M24 | The score obtained on the IKS self-questionnaire at 24 months will be compared between the two treatment groups by an analysis of covariance, with the basal IKS score as a covariate and the type of prosthesis as a factor. | 24 MONTHS |
| Measure | Description | Time Frame |
|---|---|---|
| SF12 score at M24 | The comparison between groups will be made on the evolution of scores, in relation to the baseline value, by an analysis of covariance with treatment and time as fixed factors, the subject as a random factor and the baseline value as a covariate. The interaction Time x Treatment will be added to the model. The effects of time and treatment will be tested at each evaluation point. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patient with uni or bilateral primary gonarthrosis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michel BONNIN, MD | Contact | 04 37 53 00 26 | 33 | bonnin.michel@gmail.com |
| Tarik AIT SI SELMI, MD | Contact | 04 37 53 07 04 | 33 | tarik.aitsiselmi@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| MICHEL BONNIN, MD | CENTRE ORTHOPÉDIQUE SANTY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Orthopédique Santy | Recruiting | Lyon | 69008 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38864165 | Derived | Beel W, Sappey-Marinier E, Latifi R; ReSurg; Ait-Si-Selmi T, Bonnin MP. Individualised compared to off-the-shelf total knee arthroplasty results in lower and less variable patellar tilt. Knee Surg Sports Traumatol Arthrosc. 2024 Dec;32(12):3163-3173. doi: 10.1002/ksa.12234. Epub 2024 Jun 12. | |
| 38864156 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
| 24 months |
| KOOS Score at M24 | The comparison between groups will be made on the evolution of scores, in relation to the baseline value, by an analysis of covariance with treatment and time as fixed factors, the subject as a random factor and the baseline value as a covariate. The interaction Time x Treatment will be added to the model. The effects of time and treatment will be tested at each evaluation point. | 24 months |
| Forgotten Joint Score at M24 | The comparison between groups will be made on the evolution of scores, in relation to the baseline value, by an analysis of covariance with treatment and time as fixed factors, the subject as a random factor and the baseline value as a covariate. The interaction Time x Treatment will be added to the model. The effects of time and treatment will be tested at each evaluation point. | 24 months |
| Sappey-Marinier E, Beel W; ReSurg; Bonnin MP, Ait-Si-Selmi T. Better operating room efficiency and reduced staff demand: Individualised versus off-the-shelf total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2024 Dec;32(12):3174-3184. doi: 10.1002/ksa.12233. Epub 2024 Jun 12. |
| D012216 |
| Rheumatic Diseases |