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

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04872855
• Other study ID #: CSP2017-10
• Status: Active, not recruiting
• Start date: July 17, 2020
• Est. completion date: January 15, 2032

Study information

• Verified date: August 2023
• Source: Corin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 163
• Est. completion date: January 15, 2032
• Est. primary completion date: July 15, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Knee Disease
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee
• Total Knee Arthroplasty
• Total Knee Replacement

Intervention

Device:
• patient with knee arthroplasty
patient with HLS KneeTec cementless and hybrid fixation prosthesis

Locations

Country	Name	City	State
France	Chu Angers	Angers
France	Clinique Du Parc	Caen
France	Centre Hospitalier Compiegne Noyon	Compiègne

Sponsors (1)

Lead Sponsor	Collaborator
Corin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of clinical performance of the HLS KneeTec cementless and hybrid fixations after the surgery	IKS score	starting preoperatively up to 10 years
Secondary	Evaluation of clinical performance of the HLS KneeTec cementless and hybrid fixations after the surgery	Oxford Knee Score	5 and 10 years
Secondary	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
Secondary	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