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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique du Sport, Bordeaux Mérignac

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • SPHERIKA prosthesis

    Procedure/Surgery

    total knee arthroplasty with kinematic alignement with SPHERIKA prosthesis

  • ORIGIN prosthesis

    Procedure/Surgery

    total knee arthroplasty with kinematic alignement with ORIGIN prosthesis

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: total knee arthroplasty with kinematic alignment and SPHERIKA prosthesisExperimental treatment 1 intervention
Group B: total knee arthroplasty with kinematic alignment and ORIGIN prosthesisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Evolution of "forgotten joint score"

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

Secondary outcomes

1

Frontal alignment of the lower limb

Time frame
2 months before surgery ; 45 days after surgery ; 1 year after surgery ; 2 years after surgery
2

Walking ability

Evaluation of walking ability : walking speed, cadence, stride length, stride duration

Time frame
2 years after surgery
3

Evaluation of muscular strength

Measure of : * Maximum force developed (N) * Explosivity (time required to develop maximum force, N/s) * Power (cumulative force developed during the entire acquisition period, W)

Time frame
2 years after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.