Observational Study to Evaluate Clinical Performance and Safety in Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Observational Study to Evaluate the Performance and the Safety of the HLS KneeTec Cementless or Hybrid Fixations in Total Knee Arthroplasty

Conditions
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Knee Disease, Total Knee Arthroplasty, Total Knee Replacement, Osteo Arthritis Knee

Intervention / Treatment
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* Device: patient with knee arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 18 - 80 years old at the time of the surgery Implanted (or with an indication) with an HLS KneeTec Cementless or hybrid fixation according to the Instructions for Use (IFU) 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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: patient with knee arthroplasty|patient with HLS KneeTec cementless and hybrid fixation prosthesis|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Arthroplasty, Prosthesis, Implants, HLS implants, arthroplasty