Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty

Corin

Status: Terminated

Conditions: Knee Disease; Total Knee Arthroplasty; Osteo Arthritis Knee; Total Knee Replacement

Treatments: Device: patient with knee arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT04727060

0904-T-KNEE-RM

Details and patient eligibility

About

The purpose of this study is to evaluate clinical performance and safety in total knee arthroplasty using HLS implants.

Full 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.

Enrollment: 2,146 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.