Clinique du Sport
Mérignac, 33000, France
Location status: Recruiting
NCT Number: NCT06603103
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 implants specifically for this new insertion technique. A "made-to-measure" total knee prosthesis (ORIGIN® - Symbios, Yverdon-les-Bains, Switzerland) was developed with the aim of reproducing the unique contour of each implanted knee. Another manufacturer opted to develop a generic total knee prosthesis implant (SPHERIKA® - Medacta, Castel San Pietro, Switzerland), but with a design optimized for the kinematic alignment technique. These two models of total knee prosthesis each offer advantages and limitations that need to be assessed. The main aim of this study is therefore to compare the joint perception of these 2 prostheses. It will also look at the clinical and imaging results, the biomechanics of the prosthetic knee during gait, and the muscular strength of knee extension, obtained for these 2 total knee prostheses.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Mérignac, 33000, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
total knee arthroplasty with kinematic alignement with SPHERIKA prosthesis
total knee arthroplasty with kinematic alignement with ORIGIN prosthesis
Time frame: 2 months before surgery ; 45 days after surgery ; 1 year after surgery ; 2 years after surgery
This score consists in 12 questions with a Likert scale from 0 to 5. A high score indicates a high degree of forgetfulness of the prosthesis on the part of the patient.
Time frame: 2 months before surgery ; 45 days after surgery ; 1 year after surgery ; 2 years after surgery
Time frame: 2 years after surgery
Evaluation of walking ability : walking speed, cadence, stride length, stride duration
Time frame: 2 years after surgery
Measure of :
Contact information is provided by the study sponsor or research team.
Clinique du Sport, Bordeaux Mérignac
Other
Acronym: KAOR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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