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

February 4, 2025 updated by: Corin

Observational Study to Evaluate the Performance and the Safety of the HLS KneeTec Cementless or Hybrid Fixations in Total Knee Arthroplasty

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

163

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • CHU Angers
      • Caen, France, 14000
        • Clinique du Parc
      • Compiègne, France, 60200
        • Centre Hospitalier Compiegne Noyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 10-year
Kaplan Meier survival rate up to 10 years after the surgery.
10-year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corin

Investigators

  • Principal Investigator: Franck MABESOONE, MD, CH Compiègne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2020

Primary Completion (Actual)

December 19, 2024

Study Completion (Actual)

December 19, 2024

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

April 29, 2021

First Posted (Actual)

May 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSP2017-10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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