Clinical trial NCT05211141: Study to Evaluate Long Term Performance and Safety of the Knee Prosthesis (HLS KneeTec Deep Dish)
Official title: Observational Study for the Evaluation of Long Term Performance and Safety of the HLS KneeTec Deep Dish Prosthesis in Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Total Knee Arthroplasty
Knee Disease
Total Knee Replacement
Osteo Arthritis Knee
Keywords: Knee Arthroplasty
Prosthesis
ultracongruent prosthesis
Implants
HLS implants
arthroplasty
Lead sponsor: Corin
Sponsor class: INDUSTRY
First posted: 2022-01-27
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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).

Eligibility criteria: 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.)

Primary outcomes:
measure: Evaluation of implant survival in subjects receiving a total knee arthroplasty with the HLS KneeTec Deep Dish up to 10 years after the surgery
timeFrame: 10-year
Secondary outcomes:
measure: Evaluation of functional performance of the HLS KneeTec Deep Dish after the surgery
timeFrame: preoperatively, 15 months, 5 years and 10 years
measure: Evaluation of functional performance of the HLS KneeTec Deep Dish after the surgery
timeFrame: 15 months, 5 years and 10 years
measure: Evaluation of clinical performance of the HLS KneeTec Deep Dish after the surgery
timeFrame: preoperatively, 15 months, 5 years and 10 years
measure: Evaluation of clinical performance of the HLS KneeTec Deep Dish after the surgery
timeFrame: 15 months, 5 years and 10 years
measure: radiographic evaluation of the performance of HLS KneeTec Deep Dish
timeFrame: preoperatively up to 10 years
measure: radiographic evaluation of the performance of HLS KneeTec Deep Dish
timeFrame: preoperatively up to 10 years
measure: Evaluation of safety performance during the surgery up to 10 years after the surger
timeFrame: starting intraoperatively up to 10-year FU
Other outcomes:
Locations:
city: Nancy
country: France
facility: Chru de Nancy
Study officials:
affiliation: CHRU Nancy
name: Olivier ROCHE, MD
role: PRINCIPAL_INVESTIGATOR
References: