Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2L 4M1, Canada
Location contact
Frédéric Lavoie, MD MSc FRCSC
PRINCIPAL_INVESTIGATOR
NCT Number: NCT01674816
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
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Montreal, Quebec, H2L 4M1, Canada
Frédéric Lavoie, MD MSc FRCSC
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Repeated Measurements of Knee Alignment and Kinematics using tools developed by Eiffel Medtech Inc.
Computer Guidance of Surgical Actions using tools developed by Eiffel Medtech Inc.
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)
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Fidaa Al-Shakfa, MSc
CONTACT
1-514-890-8000 ext. 26103
Frédéric Lavoie, MD MSc FRCSC
CONTACT
1-514-890-8000 ext. 25900
Centre hospitalier de l'Université de Montréal (CHUM)
Other
(Étude de la cinématique Tridimensionnelle du Genou et Guidage Chirurgical Minimalement Effractifs Par Recalage Rigide échographique)
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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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