Status:
RECRUITING
Prospective Randomized Study Comparing the SpheriKA® (MEDACTA) and Origin® (SYMBIOS) Prostheses During Total Knee Replacement Using the Kinematic Alignment Technique
Lead Sponsor:
Clinique du Sport, Bordeaux Mérignac
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 "system...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06603103
Start Date
October 3 2024
End Date
April 30 2028
Last Update
October 4 2024
Active Locations (1)
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1
Clinique du Sport
Mérignac, France, 33000