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

Corin119 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

119

Conditions

Total Knee Arthroplasty Knee Disease Total Knee Replacement Osteo Arthritis Knee

Interventions

HLS KneeTec Deep DishDEVICE

total knee arthroplasty with HLS KneeTec Deep Dish prosthesis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.)

Locations (1)

Chru de Nancy

Nancy, France

Outcomes

Primary Outcomes

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

Time frame: 10-year

Secondary Outcomes

Evaluation of functional performance of the HLS KneeTec Deep Dish after the surgery

International Knee Society (IKS) score

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 15 months, 5 years and 10 years

radiographic evaluation of the performance of HLS KneeTec Deep Dish

component positioning

Time frame: preoperatively up to 10 years

radiographic evaluation of the performance of HLS KneeTec Deep Dish

number, severity and location of radiolucencies or osteolysis

Data from ClinicalTrials.gov

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