Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eiffel Medtech | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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 :
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repeated Measurements of Knee Alignment and Kinematics | Active Comparator | Patients in the Repeated Measurements Arm will have the kinematic measurement protocol repeated twice before and twice after the surgical procedure; the procedure itself will be performed with the traditional technique, i.e without guidance by the system. |
|
| Computer Guidance of Surgical Actions | Active Comparator | Patients in the Computer Guidance of Surgical Actions Arm will have the kinematic measurement protocol performed only once before and once after the surgical procedure; the procedure itself will be performed with guidance by the system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repeated Measurements of Knee Alignment and Kinematics | Device | Repeated Measurements of Knee Alignment and Kinematics using tools developed by Eiffel Medtech Inc. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 day |
| 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. | During surgery |
| 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. | On post-operative imaging (six weeks after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical results | The clinical results after surgery will be assessed using patient questionnaire and clinical examination. | At each post-operative visit (six weeks, six months, one year, and two years after surgery) |
| Clinical results |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frédéric Lavoie, MD MSc FRCSC | Contact | 1-514-890-8000 | 25900 | fredericlavoiemd@gmail.com |
| Fidaa Al-Shakfa, MSc | Contact | 1-514-890-8000 | 26103 | f.alshakfa.crchum@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Frédéric Lavoie, MD, MSc, FRCSC | CHUM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de l'Université de Montréal (CHUM) | Montreal | Quebec | H2L 4M1 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
| Computer Guidance of Surgical Actions | Device | Computer Guidance of Surgical Actions using tools developed by Eiffel Medtech Inc. |
|
The clinical results after surgery will be assessed using the International Knee Society score.
| At each post-operative visit (six weeks, six months, one year, and two years after surgery) |
| Clinical results | The clinical results after surgery will be assessed using the KOOS score. | At each post-operative visit (six weeks, six months, one year, and two years after surgery) |
| Clinical results | The clinical results after surgery will be assessed using the SF-12 score. | At each post-operative visit (six weeks, six months, one year, and two years after surgery) |
| Clinical results | The clinical results after surgery will be assessed using the Marx activity scale. | At each post-operative visit (six weeks, six months, one year, and two years after surgery) |
| Clinical results | The clinical results after surgery will be assessed through angular and linear measurements using 3D imaging. | At each post-operative visit (six weeks, six months, one year, and two years after surgery) |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided