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Prospective Randomized Study Comparing the SpheriKA® (MEDACTA) and Origin® (SYMBIOS) Prostheses During Total Knee Replacement Using the Kinematic Alignment Technique

RecruitingNAAges 18 Years - anyAllClinique du Sport, Bordeaux Mérignac
NCT06603103 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The traditional technique for implanting a total knee prosthesis, known as mechanical alignment, does not aim to preserve the original anatomy and laxity of the knee. Instead, the implants are "systematically" aligned to create a non-naturally straight lower limb. Respectively 20% and 50% of patients with a mechanically aligned total knee prosthesis are dissatisfied with the result, and complain of residual symptoms. A newer, more physiological technique for implanting a total knee prosthesis, known as kinematic alignment, aims to recreate the unique native anatomy and laxity of each patient\'s knee. The kinematic alignment technique has been shown to reduce the risk of residual symptoms and thus improve the patient\'s experience of his or her prosthetic knee. As a result of the emergence of the kinematic alignment technique, two manufacturers have developed total knee prosthesis

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patient with indication for initial total knee replacement * Patient affiliated to a social security scheme * Patient informed of the study and formally included (informed consent signed) before the first research examination. Exclusion Criteria: * Patient with complex osteoarthritis (e.g. bone loss, history of patellar instability) * Patient with contralateral knee prosthesis * Patient with symptomatic osteoarthritis (stiffness and/or pain) of a hip or contralateral knee * Patient with another condition (acquired pathology) of the lower limbs and/or nervous system that may significantly affect gait quality * Patient deprived of liberty by judicial or administrative decision, * Patient of legal age under legal protection or unable to express consent.
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What it tests

  • SPHERIKA prosthesis
  • ORIGIN prosthesis
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Where

1 site
Clinique du Sport
Mérignac, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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