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

Corin

Status: Terminated

Conditions: Knee Disease; Total Knee Arthroplasty; Osteo Arthritis Knee; Total Knee Replacement

Treatments: Device: patient with knee arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT04872855

CSP2017-10

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 163 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.)