Skip to main content
Clinical Trials/NCT01674816
NCT01674816
Not Yet Recruiting
N/A

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

Centre hospitalier de l'Université de Montréal (CHUM)1 site in 1 country30 target enrollmentDecember 1, 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Enrollment
30
Locations
1
Primary Endpoint
3D knee kinematic assessment
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2025
End Date
December 1, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

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

  • Clinical results(At each post-operative visit (six weeks, six months, one year, and two years after surgery))

Study Sites (1)

Loading locations...

Similar Trials