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

Terminated

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

• Registration Number: NCT04872855
• Lead Sponsor: Corin

Brief Summary

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

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 Timeline

• Study Start: 2020-07-17
• Study First Submitted: 2021-04-26
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-05-05
• Primary Completion: 2024-12-19
• Study Completion: 2024-12-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 163

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	10-year	Kaplan Meier survival rate up to 10 years after the surgery.

Secondary Outcome Measures

Name	Time	Method
Evaluation of safety performance during the surgery up to 10 years after the surgery	starting intraoperatively up to 10-year FU	Number, severity and casual relationship of procedure or implant-related adverse events
Radiographic analysis of the HLS KneeTec cementless and hybrid fixations at 4 months, 1, 5 and 10 years minimum	4 months, 1, 5 and 10 years	radiological analysis from immediate postoperative up to 10-year FU
Evaluation of clinical performance of the HLS KneeTec cementless and hybrid fixations after the surgery	5 and 10 years	Oxford Knee Score

Trial Locations

Locations (3)

Clinique Du Parc; 🇫🇷 Caen, France

Centre Hospitalier Compiegne Noyon; 🇫🇷 Compiègne, France

Chu Angers; 🇫🇷 Angers, France