The purpose of this study is to evaluate clinical performance and safety in total knee arthroplasty using HLS implants.
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 Type
OBSERVATIONAL
Enrollment
2,146
Hopital de la Croix-Rousse, Hospices Civils de Lyon
Lyon, France
Evaluation of long-term survivorship of total knee replacement surgeries with HLS devices
Implants survival
Time frame: 10-year
Evaluation of clinical performance
Change of clinical performance using the International Knee Society (IKS) score
Time frame: baseline (pre-surgery) to 10-year
Evaluation of patient satisfaction with the surgery
Patients satisfaction post-surgery and any change during time up to 10-year FU using satisfaction questionnaire
Time frame: time up to 10-year FU
Radiographic evaluation
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.
Time frame: baseline (1-year FU) to 10-year FU
Evaluation of safety of the study implants
Number, severity and causal relationship of procedure or implant-related Adverse Events (AEs) starting intraoperatively up to 10-year FU.
Time frame: time up to 10-year FU
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