Clinical trial NCT04727060: Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty
Official title: A Prospective and Retrospective, Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty Using HLS Implants
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
postero-stabilized prosthesis
third condyle
Arthroplasty
Lead sponsor: Corin
Sponsor class: INDUSTRY
First posted: 2021-01-27
Enrollment: 2146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It is planned to collect prospective and retrospective data from a continuous and exhaustive series of patients in a French center where Total Knee Arthroplasty with HLS prosthesis is performed routinely.

All patients treated with HLS KneeTec (cemented, non-cemented 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 purpose of this study is to evaluate clinical performance and safety in total knee arthroplasty using HLS implants.

Detailed description: It is planned to collect prospective and retrospective data from a continuous and exhaustive series of patients in a French center where Total Knee Arthroplasty with HLS prosthesis is performed routinely.

All patients treated with HLS KneeTec (cemented, non-cemented 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.

Data will be collected retrospectively for HLS I, II, Evolution and Noetos® implants, and when prospectively for cementless, cemented and hybrid HLS KneeTec prosthesis.

Post-surgery visit data will be collected at 1-y , 3-y , 5-y, 10-y FU visits per protocol then up to the latest FU visit available.

Eligibility criteria: Inclusion Criteria:

* For the HLS-1, HLS-2, HLS Evolution and HLS Noetos retrospective group:

  1. Adult patients older than 18 years old.
  2. Patients who have undergone routine preoperative clinical evaluations prior to their Total Knee Replacement surgery and implanted with one of the following prostheses from the HLS range: HLS-1, HLS-2, HLS Evolution and HLS Noetos between their first date of use in 1987 and their last date of use as normal practice at the participating site in accordance to indications and intended use as described in the Instruction for Use (IFU) of the study devices.
  3. Patients who have been informed about their participation into an observational study.

For the HLS KneeTec prospective group (with retrospective surgeries):

1. Adult patients older than 18 years old.
2. Patients who have undergone routine preoperative clinical evaluations and received a TKR or are suitable candidates for a TKR with a fixed or mobile postero-stabilized HLS KneeTec prosthesis (cementless, cemented or hybrid combination) for the treatment of a primary or secondary knee osteoarthritis and inflammatory disease such as rheumatoid arthritis in accordance to indications and intended use as described in the Instruction for Use (IFU) of the study devices.
3. Patients who are willing and able to complete the scheduled FU visits.
4. Patients who have been informed about their participation into an observational registry study

Exclusion Criteria:

* Patients mentally incompetent or unable to understand what participation in the study entails.
* Patients who present signs and symptoms of any of the known contraindications described in the Instruction for Use (IFU) of the study devices.
* Patients who deny their participation into the study.

Primary outcomes:
measure: Evaluation of long-term survivorship of total knee replacement surgeries with HLS devices
timeFrame: 10-year
Secondary outcomes:
measure: Evaluation of clinical performance
timeFrame: baseline (pre-surgery) to 10-year
measure: Evaluation of patient satisfaction with the surgery
timeFrame: time up to 10-year FU
measure: Radiographic evaluation
timeFrame: baseline (1-year FU) to 10-year FU
measure: Evaluation of safety of the study implants
timeFrame: time up to 10-year FU
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital de la Croix-Rousse, Hospices Civils de Lyon
Study officials:
affiliation: Service de chirurgie orthopédique. Hopital de la Croix-Rousse, Hospices Civils de Lyon - France
name: Elvire SERVIEN, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: