Health TrialsbyHealthPanel

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

ConditionsKnee OsteoarthritisKnee Instability3D Knee KinematicsPrecision of Surgical ActionsClinical Outcomes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Repeated Measurements of Knee Alignment and KinematicsActive comparator 1 intervention
Group B: Computer Guidance of Surgical ActionsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

3D knee kinematic assessment

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)

Time frame
1 day
2

Precision of guided surgical actions

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.

Time frame
During surgery
3

Precision of guided surgical actions

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.

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

Secondary outcomes

1

Clinical results

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

Time frame
At each post-operative visit (six weeks, six months, one year, and two years after surgery)
2

Clinical results

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

Time frame
At each post-operative visit (six weeks, six months, one year, and two years after surgery)
3

Clinical results

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

Time frame
At each post-operative visit (six weeks, six months, one year, and two years after surgery)
4

Clinical results

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

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

Other outcomes

Sponsors and contacts

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

Centre hospitalier de l'Université de Montréal (CHUM)

Lead sponsor

Eiffel Medtech

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: