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

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05211141
• Other study ID #: CSP2017-07
• Status: Active, not recruiting
• Start date: February 28, 2017
• Est. completion date: November 1, 2027

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 Deep Dish 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 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 119
• Est. completion date: November 1, 2027
• Est. primary completion date: February 1, 2027
• 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 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.)

Related Conditions & MeSH terms

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

Intervention

Device:
• HLS KneeTec Deep Dish
total knee arthroplasty with HLS KneeTec Deep Dish prosthesis

Locations

Country	Name	City	State
France	Chru de Nancy	Nancy

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 Deep Dish up to 10 years after the surgery	kaplan Meier survival rate	10-year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	radiographic evaluation of the performance of HLS KneeTec Deep Dish	component positioning	preoperatively up to 10 years
Secondary	radiographic evaluation of the performance of HLS KneeTec Deep Dish	number, severity and location of radiolucencies or osteolysis	preoperatively up to 10 years
Secondary	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