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NCT Number: NCT01674816

Minimally Invasive Three-dimensional Knee Kinematic Assessment and Surgical Guidance Using Ultrasonic Rigid Registration

Problem:

Currently, no system allows precise kinematic assessment of the knee and accurate guiding of orthopedic surgical actions in a minimally invasive fashion. However, such a system would prove useful in the clinical setting to improve the quality of surgical interventions at the knee.

Hypothesis:

A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging and minimally invasive bony fixation allows precise kinematic assessment and surgical guidance in the routine clinical setting.

Objectives :

* Demonstrating the capacity of the system to precisely measure 3D knee kinematics * Quantifying the reproducibility of the kinematic measurements * Measuring the impact of knee surgical procedures on knee kinematics * Assessing the correlations between measured articular kinematics and clinical results after knee surgery * Integrating the novel measuring system to the surgical flow of three knee surgical procedures * Quantifying the precision and reproducibility of the surgical actions guided by the system * Comparing the clinical results of surgeries guided by the system to those performed with the traditional technique

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

Location contact

Frédéric Lavoie, MD MSc FRCSC

PRINCIPAL_INVESTIGATOR

About this study

A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging and minimally invasive bony fixation allows precise kinematic assessment and surgical guidance in the routine clinical setting.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients awaiting a knee surgery (total knee arthroplasty (TKA), high tibial osteotomy (HTO), anterior cruciate ligament reconstruction(ACLR))

Exclusion criteria

  • Active infection
  • Atypical morphology and/or alignment of the lower limbs
  • Knee instability (other than secondary to ACL deficiency in patients awaiting ACLR)
  • Knee flexion contracture of 10 degrees or more
  • Knee flexion of less than 120 degrees

Treatment and study plan

Repeated Measurements of Knee Alignment and Kinematics

Device

Repeated Measurements of Knee Alignment and Kinematics using tools developed by Eiffel Medtech Inc.

Computer Guidance of Surgical Actions

Device

Computer Guidance of Surgical Actions using tools developed by Eiffel Medtech Inc.

Primary outcomes

  1. 3D knee kinematic assessment

    Time frame: 1 day

    The system should be able to precisely and reproducibly measure 3D knee kinematics (tibio-femoral flexion, abduction-adduction, transverse rotation, and anterio-posterior and medio-lateral translations)

  2. Precision of guided surgical actions

    Time frame: During surgery

    The system should allow the surgeon to realize surgical actions, like bone cuts and guide-wire placement, within one degree and one millimeter of the desired target.

  3. Precision of guided surgical actions

    Time frame: On post-operative imaging (six weeks after surgery)

    The system should allow the surgeon to realize surgical actions, like bone cuts and guide-wire placement, within one degree and one millimeter of the desired target.

Secondary outcomes

  1. Clinical results

    Time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)

    The clinical results after surgery will be assessed using patient questionnaire and clinical examination.

  2. Clinical results

    Time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)

    The clinical results after surgery will be assessed using the International Knee Society score.

  3. Clinical results

    Time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)

    The clinical results after surgery will be assessed using the KOOS score.

  4. Clinical results

    Time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)

    The clinical results after surgery will be assessed using the SF-12 score.

  5. Clinical results

    Time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)

    The clinical results after surgery will be assessed using the Marx activity scale.

  6. Clinical results

    Time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)

    The clinical results after surgery will be assessed through angular and linear measurements using 3D imaging.

Study contacts

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

Fidaa Al-Shakfa, MSc

CONTACT

[email protected]

1-514-890-8000 ext. 26103

Frédéric Lavoie, MD MSc FRCSC

CONTACT

[email protected]

1-514-890-8000 ext. 25900

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Eiffel Medtech

Registry information

Official study title

(Étude de la cinématique Tridimensionnelle du Genou et Guidage Chirurgical Minimalement Effractifs Par Recalage Rigide échographique)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2012
Registry last updated
Feb 12, 2024

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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