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

NCT04872855 | Terminated

• 1 other identifier: CSP2017-10
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Knee Arthroplasty; Prosthesis; Implants; HLS implants; arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  starting preoperatively up to 10 years

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

  5 and 10 years

• 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

• Evaluation of safety performance during the surgery up to 10 years after the surgery

  starting intraoperatively up to 10-year FU

Interventions

patient with knee arthroplasty DEVICE

patient with HLS KneeTec cementless and hybrid fixation prosthesis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• \- 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.)

Sponsors & Collaborators

• Corin: lead

Study Sites (3)

Chu Angers

Angers, 49933, France

Location

Clinique Du Parc

Caen, 14000, France

Location

Centre Hospitalier Compiegne Noyon

Compiègne, 60200, France

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Franck MABESOONE, MD

  CH COMPIEGNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 5, 2021
• Study Start: July 17, 2020
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

FR (3)