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

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: Active, not recruiting
• Conditions: Osteo Arthritis Knee; Total Knee Arthroplasty; Total Knee Replacement; Knee Disease
• Intervention / Treatment: Device: patient with knee arthroplasty

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

Study Locations

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

Participation Criteria

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

How is the study designed?

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	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	IKS score	starting preoperatively up to 10 years
Evaluation of clinical performance of the HLS KneeTec cementless and hybrid fixations after the surgery	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	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	Number, severity and casual relationship of procedure or implant-related adverse events	starting intraoperatively up to 10-year FU

Collaborators and Investigators

• Sponsor: Corin
• Investigators: Principal Investigator: Franck MABESOONE, MD, CH Compiègne

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2020
• Primary Completion (Estimated): July 15, 2031
• Study Completion (Estimated): January 15, 2032

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): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Prosthesis; arthroplasty; Knee Arthroplasty; Implants; HLS implants
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• 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