Clinical trial NCT01674816: Minimally Invasive Three-dimensional Knee Kinematic Assessment and Surgical Guidance Using Ultrasonic Rigid Registration
Official title: (Étude de la cinématique Tridimensionnelle du Genou et Guidage Chirurgical Minimalement Effractifs Par Recalage Rigide échographique)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Knee Instability
3D Knee Kinematics
Precision of Surgical Actions
Clinical Outcomes
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Eiffel Medtech
First posted: 2012-08-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 3D knee kinematic assessment
timeFrame: 1 day
measure: Precision of guided surgical actions
timeFrame: During surgery
measure: Precision of guided surgical actions
timeFrame: On post-operative imaging (six weeks after surgery)
Secondary outcomes:
measure: Clinical results
timeFrame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
measure: Clinical results
timeFrame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
measure: Clinical results
timeFrame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
measure: Clinical results
timeFrame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
measure: Clinical results
timeFrame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
measure: Clinical results
timeFrame: At each post-operative visit (six weeks, six months, one year, and two years after surgery)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: CHUM
name: Frédéric Lavoie, MD, MSc, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: