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| Name | Class |
|---|---|
| Clinical Investigation Centre for Innovative Technology Network | NETWORK |
| Stryker Orthopaedics | INDUSTRY |
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For the total knee arthrorplasty (TKA), the placement of a prosthesis is delicate and the correct positioning of the implants determines the result of the surgery.
Navigation has improved surgical accuracy but remains inadequate with nearly 20% malposition. In the early 2010s, robot-assisted surgery solutions were born. Amongst its offers, Stryker's MAKO™ system appears to be the most advanced and developed due to its precision and its flexibility of use during surgery.
In this study, the investigators evaluate the placement of the total knee prosthesis with the MAKO™ system compared to the placement of the total knee prosthesis with a conventional mechanical system for TKA
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total knee arthroplasty with the Stryker's MAKO™ system | Experimental | The total knee arthroplasty is performed with Stryker's MAKO™ robotic system. It allows to place precisely the prosthetic implants. |
|
| Total knee arthroplasty with mechanical ancillary | Active Comparator | The total knee arthroplasty is performed using a mechanical ancillary. It's the conventional method. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total knee arthroplasty with the Stryker's MAKO™ system | Procedure | The robot assisted surgery is performed using the Stryker's MAKO™ system. The precision with this system is very accurate. It should help the surgeon to improve the positioning accuracy of prosthetic implants compared to the conventional method. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between the actual HKA angle obtained postoperatively and the planned HKA angle preoperatively. | HKA (Hip-Knee-Ankle). Angles in degrees are obtained from preoperative 3D scanner and postoperative 3D scanner on day 7. | 26 months |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the mechanical axis between the conventional surgery group and the MAKO™ assisted surgery group. | Mechanical axis (in degree) evaluated from the post-operative 3D computed tomography on the day 7. | 26 months |
| To compare, between the conventional surgery group and the MAKO™ assisted surgery group, the angles accuracy of inclination and rotation in the 3 planes of the space (frontal, sagittal and axial) to accomplish the preoperative planning. The accuracy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Régis Pailhé, MD, PhD | Contact | +33 617970492 | rpailhe@chu-grenoble.fr | |
| Emilie Chipon, PhD | Contact | +33 476767313 | echipon@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Régis Pailhé, PhD | Centre Hospitalier Universitaire Grenoble-Alpes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Grenoble Hospital | Recruiting | Échirolles | 38130 | France |
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| Total knee arthroplasty with mechanical ancillary | Procedure | The arthroplasty is performed with the mechanical ancillary refering to the the conventional method. |
|
difference between the angles of inclination and rotation obtained postoperatively and the planned angles preoperatively, in the 3 planes of the space. The angles, in degree, are evaluated from 3D preoperative scan and postoperative 3D scan. |
| 26 months |
| To compare the operative time between the conventional surgery group and the MAKO™ assisted surgery group. | Duration (in minutes) between the time of the last stitch and the time of the first incision. | 26 months |
| To evaluate the conversion rate in conventional method for patients in the MAKO™ assisted surgery group. | Conversion number to conventional method. | 26 months |
| To compare the blood loss during the procedure between the conventional surgery group and the MAKO™ assisted surgery group. | Blood loss in liter according to the BRECHER formula (see Appendix E). | 26 months |
| To compare between the conventional surgery group and the MAKO™ assisted surgery group the time needed to reach the hospital discharge criteria. | Duration (in days) between the date of the surgery and the date on which the patient can ascend the stairs on one floor and walk 100 meters with a cane. | 26 months |
| To compare the functional results between the conventional surgery group and the MAKO™ assisted surgery group. | KSS, KOOS and EQ5D-3L scores at inclusion, then at 3 months, 6 months, and 1 year postoperatively. | 26 months |
| To compare intraoperative complication rates between the conventional surgery group and the MAKO™ assisted surgery group. | Number of intraoperative complications. The complications are classified according to the following classification: light grade 1; moderate level 2; severe grade 3. | 26 months |
| To compare the results of early (<1 months) and late (≥ 1 month) postoperative consultations between the conventional surgery group and the MAKO™-assisted surgery group. | Number of early (<1 month) and late (≥ 1 month) postoperative complications. Complications are classified according to the following classification: mild grade 1; moderate level 2; severe grade 3 | 26 months |
| To compare between the conventional surgery group and the MAKO™-assisted surgery group the operating times for surgical installation, bone preparation and implant placement. |
| 26 months |
| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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