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

Terminated

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

• Registration Number: NCT04727060
• Lead Sponsor: Corin

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.

Study Timeline

• Study Start: 2011-12-15
• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2021-01-26
• Study First Posted: 2021-01-27
• Primary Completion: 2023-11
• Study Completion: 2023-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2146

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of long-term survivorship of total knee replacement surgeries with HLS devices	10-year	Implants survival

Secondary Outcome Measures

Name	Time	Method
Evaluation of clinical performance	baseline (pre-surgery) to 10-year	Change of clinical performance using the International Knee Society (IKS) score
Radiographic evaluation	baseline (1-year FU) to 10-year FU	Implant positioning and stability, presence/absence of progressive radiolucent lines around implant components, any sign of loosening components via radiological evaluation from baseline (1-year FU) to 10-year FU.
Evaluation of safety of the study implants	time up to 10-year FU	Number, severity and causal relationship of procedure or implant-related Adverse Events (AEs) starting intraoperatively up to 10-year FU.
Evaluation of patient satisfaction with the surgery	time up to 10-year FU	Patients satisfaction post-surgery and any change during time up to 10-year FU using satisfaction questionnaire

Trial Locations

Locations (1)

Hopital de la Croix-Rousse, Hospices Civils de Lyon; 🇫🇷 Lyon, France