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the clinical data collected to date are 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 cementless and hybrid fixation 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 French sites where Total Knee Arthroplasty with HLS Kneetec cementless and hybrid fixation knee prosthesis is performed routinely
All patients treated with HLS KneeTec (cementless or hybrid versions) 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: 4 months (+/- 2 months); 1 year (+/- 2 months); 5 years (+/- 12 months) and 10 years (+/- 12 months).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patient with knee arthroplasty | Device | patient with HLS KneeTec cementless and hybrid fixation prosthesis |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of implant survival in subjects receiving a total knee arthroplasty with the HLS KneeTec cementless and hybrid fixations up to 10 years after the surgery | Kaplan Meier survival rate up to 10 years after the surgery. | 10-year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of clinical performance of the HLS KneeTec cementless and hybrid fixations after the surgery | IKS score | starting preoperatively up to 10 years |
| Evaluation of clinical performance of the HLS KneeTec cementless and hybrid fixations after the surgery |
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Inclusion Criteria:
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.)
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All patients treated with HLS KneeTec (cementless or hybrid versions) 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 |
|---|---|---|
| Franck MABESOONE, MD | CH COMPIEGNE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Angers | Angers | 49933 | France | |||
| Clinique Du Parc |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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Oxford Knee Score |
| 5 and 10 years |
| Radiographic analysis of the HLS KneeTec cementless and hybrid fixations at 4 months, 1, 5 and 10 years minimum | radiological analysis from immediate postoperative up to 10-year FU | 4 months, 1, 5 and 10 years |
| Evaluation of safety performance during the surgery up to 10 years after the surgery | Number, severity and casual relationship of procedure or implant-related adverse events | starting intraoperatively up to 10-year FU |
| Caen |
| 14000 |
| France |
| Centre Hospitalier Compiegne Noyon | Compiègne | 60200 | France |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |