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NCT Number: NCT06603103

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique du Sport

Mérignac, 33000, France

Location status: Recruiting

Location contact

Charles Rivière, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SPHERIKA prosthesis

Procedure

total knee arthroplasty with kinematic alignement with SPHERIKA prosthesis

ORIGIN prosthesis

Procedure

total knee arthroplasty with kinematic alignement with ORIGIN prosthesis

Primary outcomes

  1. Evolution of "forgotten joint score"

    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.

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

    Time frame: 2 years after surgery

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

  3. Evaluation of muscular strength

    Time frame: 2 years after surgery

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Charles Rivière, MD

CONTACT

[email protected]

+335 56 46 32 33

Sponsors and collaborators

Lead sponsor

Clinique du Sport, Bordeaux Mérignac

Other

Registry information

Acronym: KAOR

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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