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

Observational Study for the Evaluation of Long Term Performance and Safety of the HLS KneeTec Deep Dish Prosthesis in Total Knee Arthroplasty

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

Study Overview

• Status: Active, not recruiting
• Conditions: Osteo Arthritis Knee; Total Knee Arthroplasty; Total Knee Replacement; Knee Disease
• Intervention / Treatment: Device: HLS KneeTec Deep Dish

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 Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • CHRU de Nancy

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 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with knee arthroplasty; patient with HLS KneeTec Deep Dish prosthesis	Device: HLS KneeTec Deep Dish; total knee arthroplasty with HLS KneeTec Deep Dish prosthesis

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 Deep Dish up to 10 years after the surgery	kaplan Meier survival rate	10-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of functional performance of the HLS KneeTec Deep Dish after the surgery	International Knee Society (IKS) score	preoperatively, 15 months, 5 years and 10 years
Evaluation of functional performance of the HLS KneeTec Deep Dish after the surgery	Oxford Knee Score (OKS) _ score of each question from 0 to 4 with 4 being the best outcome	15 months, 5 years and 10 years
Evaluation of clinical performance of the HLS KneeTec Deep Dish after the surgery	Devane's score_level of activity 1 to 5 with 5 being the high level of activity	preoperatively, 15 months, 5 years and 10 years
Evaluation of clinical performance of the HLS KneeTec Deep Dish after the surgery	Satisfaction score on a 4-point Likert-type scale, level of satisfaction 1 to 4 with 4 being the high level of satisfaction	15 months, 5 years and 10 years
radiographic evaluation of the performance of HLS KneeTec Deep Dish	component positioning	preoperatively up to 10 years
radiographic evaluation of the performance of HLS KneeTec Deep Dish	number, severity and location of radiolucencies or osteolysis	preoperatively up to 10 years
Evaluation of safety performance during the surgery up to 10 years after the surger	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: Olivier ROCHE, MD, CHRU Nancy

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2017
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 27, 2022

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; ultracongruent prosthesis; HLS implants
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CSP2017-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No