Clinical trial NCT04872855: Observational Study to Evaluate Clinical Performance and Safety in Total Knee Arthroplasty
Official title: Observational Study to Evaluate the Performance and the Safety of the HLS KneeTec Cementless or Hybrid Fixations 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
Implants
HLS implants
arthroplasty
Lead sponsor: Corin
Sponsor class: INDUSTRY
First posted: 2021-05-05
Enrollment: 163
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 (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

Brief 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.

Detailed 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).

Eligibility criteria: 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.)

Primary outcomes:
measure: 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
timeFrame: 10-year
Secondary outcomes:
measure: Evaluation of clinical performance of the HLS KneeTec cementless and hybrid fixations after the surgery
timeFrame: starting preoperatively up to 10 years
measure: Evaluation of clinical performance of the HLS KneeTec cementless and hybrid fixations after the surgery
timeFrame: 5 and 10 years
measure: Radiographic analysis of the HLS KneeTec cementless and hybrid fixations at 4 months, 1, 5 and 10 years minimum
timeFrame: 4 months, 1, 5 and 10 years
measure: Evaluation of safety performance during the surgery up to 10 years after the surgery
timeFrame: starting intraoperatively up to 10-year FU
Other outcomes:
Locations:
city: Angers
country: France
facility: Chu Angers
city: Caen
country: France
facility: Clinique Du Parc
city: Compiègne
country: France
facility: Centre Hospitalier Compiegne Noyon
Study officials:
affiliation: CH COMPIEGNE
name: Franck MABESOONE, MD
role: PRINCIPAL_INVESTIGATOR
References: