Menu
Not yet recruiting NCT01674816

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

No phase Interventional Knee Osteoarthritis Knee Instability 3D Knee Kinematics Precision of Surgical Actions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Repeated Measurements of Knee Alignment and Kinematics, Computer Guidance of Surgical Actions.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis, Knee Instability, 3D Knee Kinematics, Precision of Surgical Actions. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Repeated Measurements of Knee Alignment and Kinematics
    Repeated Measurements of Knee Alignment and Kinematics using tools developed by Eiffel Medtech Inc.
  • Device Computer Guidance of Surgical Actions
    Computer Guidance of Surgical Actions using tools developed by Eiffel Medtech Inc.

Primary outcome measures

  • 3D knee kinematic assessment [Time frame: 1 day]
  • Precision of guided surgical actions [Time frame: During surgery]
  • Precision of guided surgical actions [Time frame: On post-operative imaging (six weeks after surgery)]
Secondary outcome measures (6)
  • Clinical results [Time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)]
  • Clinical results [Time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)]
  • Clinical results [Time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)]
  • Clinical results [Time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)]
  • Clinical results [Time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)]
  • Clinical results [Time frame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal

Identifiers

NCT: NCT01674816 · CE12.006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗