Knee Disease, Osteo Arthritis Knee, Total Knee Arthroplasty, Total Knee Replacement
Conditions
Keywords
Knee Arthroplasty, Prosthesis, ultracongruent prosthesis, Implants, HLS implants, arthroplasty
Brief summary
The aim of this study is to assess the long-term performance and safety of HLS KneeTec Deep Dish knee prosthesis when used in standard medical practice
Detailed description
It is planned to collect prospective and retrospective data from a continuous and exhaustive series of patients in a single French site where Total Knee Arthroplasty with HLS Kneetec Deep Dish prosthesis is performed routinely All patients treated with HLS KneeTec Deep Dish implant will be included. All eligible patients seen in consultation and who agree to participate in the study should be included, systematically and consecutively, since the initiation of the study. Patients will be assessed according to the usual practice of the investigator at each participating site before surgery and then at the follow-up (FU) visits as following: 3 months (+/- 1 months); 15 months (+/- 3 months); 5 years (+/- 6 months) and 10 years (+/- 6 months).
Interventions
DEVICEHLS KneeTec Deep Dish
total knee arthroplasty with HLS KneeTec Deep Dish prosthesis
Sponsors
Corin
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18 - 80 years old at the time of the surgery * Implanted with an HLS KneeTec Deep Dish TKP according to the Instructions for Use (IFU) after the 1st of february, 2017 * Patients agree to consent to collect data from their medical records and agree to answer questionnaires for the purposes of the study.
Exclusion criteria
* Patients under guardianship and/or those who, according to the investigator or his delegated research team, will not be able to comply with the study procedures. (e.g. illiteracy, recent psychotic or manic disorders and/or inability to comply with routine follow-up visits.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of implant survival in subjects receiving a total knee arthroplasty with the HLS KneeTec Deep Dish up to 10 years after the surgery | 10-year | kaplan Meier survival rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of functional performance of the HLS KneeTec Deep Dish after the surgery | preoperatively, 15 months, 5 years and 10 years | International Knee Society (IKS) score |
| Evaluation of clinical performance of the HLS KneeTec Deep Dish after the surgery | preoperatively, 15 months, 5 years and 10 years | Devane's score\_level of activity 1 to 5 with 5 being the high level of activity |
| radiographic evaluation of the performance of HLS KneeTec Deep Dish | preoperatively up to 10 years | component positioning |
| Evaluation of safety performance during the surgery up to 10 years after the surger | starting intraoperatively up to 10-year FU | Number, severity and casual relationship of procedure or implant-related adverse events |
Countries
France
Outcome results
None listed