Status:
TERMINATED
Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty
Lead Sponsor:
Corin
Conditions:
Total Knee Arthroplasty
Knee Disease
Eligibility:
All Genders
18+ years
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 routin...
Eligibility Criteria
Inclusion
- For the HLS-1, HLS-2, HLS Evolution and HLS Noetos retrospective group:
- Adult patients older than 18 years old.
- 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.
- Patients who have been informed about their participation into an observational study.
- For the HLS KneeTec prospective group (with retrospective surgeries):
- Adult patients older than 18 years old.
- 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.
- Patients who are willing and able to complete the scheduled FU visits.
- Patients who have been informed about their participation into an observational registry study
Exclusion
- 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.
Key Trial Info
Start Date :
December 15 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
2146 Patients enrolled
Trial Details
Trial ID
NCT04727060
Start Date
December 15 2011
End Date
November 1 2023
Last Update
July 16 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hopital de la Croix-Rousse, Hospices Civils de Lyon
Lyon, France, 69000