An interventional study of Total knee arthroplasty with the Stryker's MAKO™ system and Total knee arthroplasty with mechanical ancillary in Total Knee Arthroplasty, sponsored by University Hospital, Grenoble. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-20.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Treatment
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
University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The total knee arthroplasty is performed with Stryker's MAKO™ robotic system. It allows to place precisely the prosthetic implants.
Procedure: Total knee arthroplasty with the Stryker's MAKO™ system
The total knee arthroplasty is performed using a mechanical ancillary. It's the conventional method.
Procedure: Total knee arthroplasty with mechanical ancillary
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.
The arthroplasty is performed with the mechanical ancillary refering to the the conventional method.
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.
Time frame: 26 months
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.
Time frame: 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
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.
Time frame: 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.
Time frame: 26 months
To evaluate the conversion rate in conventional method for patients in the MAKO™ assisted surgery group.
Conversion number to conventional method.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
1. for the surgical installation step: duration in minutes between the start of installation time (= end of anesthesia) and the time of first incision; 2. for the bone preparation step: duration in minutes between the time of the first incision and the hour of end of extraction of the femoral sections; 3. for the implant placement stage: duration in minutes between the start time of placement of the trial tibial implant and the time of the last stitch.
Time frame: 26 months
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University Hospital, Grenoble