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NCT Number: NCT06158646

Mechanically or Kinematically Aligned Total Knee Prosthesis

The mechanical alignment technique (Mechanical Alignment - MA) of a total knee prosthesis (TKA) was developed with the aim of making the installation of a TKA simple and reproducible, and that the prosthetic biomechanics are acceptable, thus promoting good longevity of implants. This is a technique that does not aim to restore the constitutional anatomy of the knee; bone cuts are systematically made at fixed angles, in the 3 planes of space, in relation to the mechanical axes of the long bones (femur and tibia). This non-personalized implantation technique therefore systematically alters the anatomy, laxity and kinematics of the knee, causing up to 50% of residual symptoms after prosthetic implantation and 20% of dissatisfied patients.

In order to improve the clinical results of TKA, a new, more personalized and physiological technique was developed in 2007, called Kinematic Alignment (KA). This technique aims to restore the pre-arthritic anatomy, unique to each knee. Patients with severe constitutional deformity of the lower limb therefore retain this deformity after kinematic prosthetic replacement. The impact of the alignment technique on the biomechanics of the prosthetic knee remains poorly described. The main objective of this study is therefore to compare knee biomechanics between mechanical TKA and kinematic TKA.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient followed as part of a consultation 1 year after TKA placement
  • Adult patient
  • Patient affiliated to a social security system
  • Patient informed of the study and formally included (signing of informed consent) before the first research review

Exclusion criteria

  • Patient with a contralateral knee prosthesis
  • Patient with another condition (acquired pathology) of the lower limbs (e.g. severe osteoarthritis of the contralateral knee or hip/ankle) and/or of the nervous system (e.g. Parkinson's) which may significantly affect the quality of walking
  • Pregnant patient
  • Patient deprived of liberty by judicial or administrative decision,
  • Adult patient subject to a legal protection measure or unable to express consent

Treatment and study plan

kinematic knee prosthesis

Device

Patients with a kinematically aligned total knee prosthesis and having a post-operative follow-up consultation within at least 1 year after their surgery are consecutively pre-selected according to the eligibility criteria.

biomechanic knee prosthesis

Device

A group of patients with a mechanically aligned TKA and scheduled for a follow-up consultation 1 year after surgery will be identified to be matched on the aforementioned criteria (sex, age, BMI).

Primary outcomes

  1. Biomechanical parameters of knee : spatiotemporal parameters

    Time frame: One year after surgery

    When walking on flat ground and when going up/down stairs:

    walking speed

  2. Biomechanical parameters of knee : Kinematic parameters in the 3 planes of space

    Time frame: One year after surgery

    dynamic hip-knee-ankle angles during the knee flexion/extension test with and without support

  3. Biomechanical parameters of knee : joint moments

    Time frame: One year after surgery

    Unit : Newton meter

  4. Biomechanical parameters of knee : force

    Time frame: One year after surgery

    Unit : body weight

  5. Biomechanical parameters of knee : lever arms

    Time frame: One year after surgery

  6. Symmetry index between the operated limb and the healthy controlateral limb

    Time frame: One year after surgery

    Comparison between the two limbs

Secondary outcomes

  1. Clinical results : Patient-Reported Outcome Measures: Functional score (OXFORD scale)

    Time frame: One year after surgery

    OXFORD scale : numerical rating scale used to quantify the power or strength produced by the contraction of a muscle (0-5) ; 5 is maximal strenght

  2. Clinical results : Patient-Reported Outcome Measures: joint perception score

    Time frame: One year after surgery

    Forgotten joint score : joint-specific questionnaire that focuses on the patients' awareness of their prosthetic joint during daily activities ; 0-100 (0 is the worst result and 100 the better result possible)

  3. Clinical results : Patient-Reported Outcome Measures: pain

    Time frame: One year after surgery

    visual analog scale (VAS) pain (numerical scale 0-10), 0 is absence of pain and 10 the worst pain possible

  4. Clinical results : Patient satisfaction

    Time frame: One year after surgery

    Scale from "not at all satisfied" to "very satisfied"

  5. Clinical results : range of mobility of the prosthetic knee

    Time frame: One year after surgery

    Range of motion from hyperextension to flexion (degrees)

  6. Clinical results : complication rate

    Time frame: One year after surgery

    Complication rate (percentage) : manipulation under anesthesia, re-operation, revision, previous pain syndrome

  7. Imaging results : EOS 3D, alignement of the lower limb

    Time frame: One year after surgery

    measurement of the frontal alignment of the lower limb (hip-knee-ankle and hip-knee-calcaneus angles)

  8. Imaging results : EOS 3D, orientation of the implants

    Time frame: One year after surgery

    • measurement of the orientation of the implants in the frontal (medial proximal tibial, lateral distal femoral and joint line convergence angles) and sagittal (tibial slope, flexion of the femoral component) planes

  9. Imaging results : EOS 3D, distance between anterior femoral cortex and prosthetic trochlea

    Time frame: One year after surgery

    measurement of the distance between the anterior femoral cortex and the prosthetic trochlea

  10. Imaging results : radiography, evaluation of implant fixation

    Time frame: One year after surgery

    evaluation of implant fixation (e.g. sealing, border, reactive line)

  11. Imaging results : radiography, measurement of patellar height

    Time frame: One year after surgery

    measurement of patellar height (pre- and post-op Caton-Deschamps index comparison)

  12. Imaging results : radiography, evaluation of the bone structure

    Time frame: One year after surgery

    evaluation of bone structure (e.g. osteolysis)

Study contacts

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

Charles Rivière, MD

CONTACT

[email protected]

+33 5 56 46 10 40

Sponsors and collaborators

Lead sponsor

Clinique du Sport, Bordeaux Mérignac

Other

Registry information

Official study title

Mechanically or Kinematically Aligned Total Knee Prosthesis: Prospective and Comparative Study of Clinical, Stereoradiographic, and Biomechanical Results

Acronym: BIOMAKA

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 6, 2023
Registry last updated
Apr 6, 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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