Study to Evaluate Long Term Performance and Safety of the Knee Prosthesis (HLS KneeTec Deep Dish)

Terminated

• Conditions: Total Knee Arthroplasty; Osteo Arthritis Knee; Total Knee Replacement; Knee Disease
• Interventions: Device: HLS KneeTec Deep Dish

• Registration Number: NCT05211141
• Lead Sponsor: Corin

Brief Summary

The aim of this study is to assess the long-term performance and safety of HLS KneeTec Deep Dish 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 a single French site where Total Knee Arthroplasty with HLS Kneetec Deep Dish prosthesis is performed routinely

All patients treated with HLS KneeTec Deep Dish 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: 3 months (+/- 1 months); 15 months (+/- 3 months); 5 years (+/- 6 months) and 10 years (+/- 6 months).

Study Timeline

• Study Start: 2017-02-28
• Study First Submitted: 2022-01-11
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-27
• Primary Completion: 2022-12-21
• Study Completion: 2022-12-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

• Male or female aged 18 - 80 years old at the time of the surgery
• Implanted with an HLS KneeTec Deep Dish TKP according to the Instructions for Use (IFU) after the 1st of february, 2017
• 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

Arm && Interventions

Group	Intervention	Description
Patient with knee arthroplasty	HLS KneeTec Deep Dish	patient with HLS KneeTec Deep Dish prosthesis

Primary Outcome Measures

Name	Time	Method
Evaluation of implant survival in subjects receiving a total knee arthroplasty with the HLS KneeTec Deep Dish up to 10 years after the surgery	10-year	kaplan Meier survival rate

Secondary Outcome Measures

Name	Time	Method
radiographic evaluation of the performance of HLS KneeTec Deep Dish	preoperatively up to 10 years	number, severity and location of radiolucencies or osteolysis
Evaluation of functional performance of the HLS KneeTec Deep Dish after the surgery	15 months, 5 years and 10 years	Oxford Knee Score (OKS) _ score of each question from 0 to 4 with 4 being the best outcome
Evaluation of clinical performance of the HLS KneeTec Deep Dish after the surgery	15 months, 5 years and 10 years	Satisfaction score on a 4-point Likert-type scale, level of satisfaction 1 to 4 with 4 being the high level of satisfaction
Evaluation of safety performance during the surgery up to 10 years after the surger	starting intraoperatively up to 10-year FU	Number, severity and casual relationship of procedure or implant-related adverse events

Trial Locations

Locations (1)

Chru de Nancy; 🇫🇷 Nancy, France