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the clinical data collected to date is sufficient for regulatory requirements
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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with knee arthroplasty | patient with HLS KneeTec Deep Dish prosthesis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLS KneeTec Deep Dish | Device | total knee arthroplasty with HLS KneeTec Deep Dish prosthesis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of implant survival in subjects receiving a total knee arthroplasty with the HLS KneeTec Deep Dish up to 10 years after the surgery | kaplan Meier survival rate | 10-year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of functional performance of the HLS KneeTec Deep Dish after the surgery | International Knee Society (IKS) score | preoperatively, 15 months, 5 years and 10 years |
| Evaluation of functional performance of the HLS KneeTec Deep Dish after the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Olivier ROCHE, MD | CHRU Nancy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chru de Nancy | Nancy | 54000 | France |
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Oxford Knee Score (OKS) _ score of each question from 0 to 4 with 4 being the best outcome |
| 15 months, 5 years and 10 years |
| Evaluation of clinical performance of the HLS KneeTec Deep Dish after the surgery | Devane's score_level of activity 1 to 5 with 5 being the high level of activity | preoperatively, 15 months, 5 years and 10 years |
| Evaluation of clinical performance of the HLS KneeTec Deep Dish after the surgery | Satisfaction score on a 4-point Likert-type scale, level of satisfaction 1 to 4 with 4 being the high level of satisfaction | 15 months, 5 years and 10 years |
| radiographic evaluation of the performance of HLS KneeTec Deep Dish | component positioning | preoperatively up to 10 years |
| radiographic evaluation of the performance of HLS KneeTec Deep Dish | number, severity and location of radiolucencies or osteolysis | preoperatively up to 10 years |
| Evaluation of safety performance during the surgery up to 10 years after the surger | Number, severity and casual relationship of procedure or implant-related adverse events | starting intraoperatively up to 10-year FU |