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

Corin163 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

163

Conditions

Total Knee Arthroplasty Knee Disease Total Knee Replacement Osteo Arthritis Knee

Interventions

patient with knee arthroplastyDEVICE

patient with HLS KneeTec cementless and hybrid fixation 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 (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.)

Locations (3)

Chu Angers

Angers, France

Clinique Du Parc

Caen, France

Centre Hospitalier Compiegne Noyon

Compiègne, France

Outcomes

Primary Outcomes

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.

Time frame: 10-year

Secondary Outcomes

Evaluation of clinical performance of the HLS KneeTec cementless and hybrid fixations after the surgery

IKS score

Time frame: starting preoperatively up to 10 years

Evaluation of clinical performance of the HLS KneeTec cementless and hybrid fixations after the surgery

Oxford Knee Score

Time frame: 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

Time frame: 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

Time frame: starting intraoperatively up to 10-year FU

Data from ClinicalTrials.gov

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