Study to Evaluate Long Term Performance and Safety of the Knee Prosthesis (HLS KneeTec Deep Dish)

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 Deep Dish 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 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).

Official Title
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Observational Study for the Evaluation of Long Term Performance and Safety of the HLS KneeTec Deep Dish Prosthesis in Total Knee Arthroplasty

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

Intervention / Treatment
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* Device: HLS KneeTec Deep Dish


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 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.)

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with knee arthroplasty<br>patient with HLS KneeTec Deep Dish prosthesis | Device: HLS KneeTec Deep Dish<br>* total knee arthroplasty with HLS KneeTec Deep Dish prosthesis<br>|

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 Deep Dish up to 10 years after the surgery | kaplan Meier survival rate | 10-year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

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