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Total Knee Arthroplasty Robot Assisted With MAKO™ Robotic System Compared to the Conventional Total Knee Arthroplasty by Mechanical Ancillary (TKA-MAKO)

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ClinicalTrials.gov Identifier: NCT03566875
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Collaborators:
Clinical Investigation Centre for Innovative Technology Network
Stryker European Operations BV
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Procedure: Total knee arthroplasty with the Stryker's MAKO™ system Procedure: Total knee arthroplasty with mechanical ancillary Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Etude Clinique, Monocentrique, Prospective, randomisée et contrôlés de l'Arthoplastie Totale de Genou Avec le système Robotique MAKO™ Par Rapport à l'Arthroplastie Totale de Genou Conventionnelle Par Ancillaire mécanique
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : September 23, 2020
Estimated Study Completion Date : September 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Total knee arthroplasty with the Stryker's MAKO™ system
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 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.

Active Comparator: Total knee arthroplasty with mechanical ancillary
The total knee arthroplasty is performed using a mechanical ancillary. It's the conventional method.
Procedure: Total knee arthroplasty with mechanical ancillary
The arthroplasty is performed with the mechanical ancillary refering to the the conventional method.




Primary Outcome Measures :
  1. Difference between the actual HKA angle obtained postoperatively and the planned HKA angle preoperatively. [ Time Frame: 26 months ]
    HKA (Hip-Knee-Ankle). Angles in degrees are obtained from preoperative 3D scanner and postoperative 3D scanner on day 7.


Secondary Outcome Measures :
  1. To compare the mechanical axis between the conventional surgery group and the MAKO™ assisted surgery group. [ Time Frame: 26 months ]
    Mechanical axis (in degree) evaluated from the post-operative 3D computed tomography on the day 7.

  2. 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 [ Time Frame: 26 months ]
    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.

  3. To compare the operative time between the conventional surgery group and the MAKO™ assisted surgery group. [ Time Frame: 26 months ]
    Duration (in minutes) between the time of the last stitch and the time of the first incision.

  4. To evaluate the conversion rate in conventional method for patients in the MAKO™ assisted surgery group. [ Time Frame: 26 months ]
    Conversion number to conventional method.

  5. To compare the blood loss during the procedure between the conventional surgery group and the MAKO™ assisted surgery group. [ Time Frame: 26 months ]
    Blood loss in liter according to the BRECHER formula (see Appendix E).

  6. To compare between the conventional surgery group and the MAKO™ assisted surgery group the time needed to reach the hospital discharge criteria. [ Time Frame: 26 months ]
    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.

  7. To compare the functional results between the conventional surgery group and the MAKO™ assisted surgery group. [ Time Frame: 26 months ]
    KSS, KOOS and EQ5D-3L scores at inclusion, then at 3 months, 6 months, and 1 year postoperatively.

  8. To compare intraoperative complication rates between the conventional surgery group and the MAKO™ assisted surgery group. [ Time Frame: 26 months ]
    Number of intraoperative complications. The complications are classified according to the following classification: light grade 1; moderate level 2; severe grade 3.

  9. 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. [ Time Frame: 26 months ]
    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

  10. To compare between the conventional surgery group and the MAKO™-assisted surgery group the operating times for surgical installation, bone preparation and implant placement. [ Time Frame: 26 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major patient
  • Patient who must have a total prosthetic knee surgery at CHUGA with the useful indications : painful and disabling knee joint disease: traumatic arthritis or avascular necrosis, rheumatoid arthritis or post-traumatic arthritis, post-traumatic loss of the configuration and function of the knee joint, moderate deformities in varus, or valgus or flexion in ligamentous structures can find a function and a fracture of the distal femur and / or proximal tibia that can not be stabilized by standard fracture management techniques.
  • Social security affiliates or beneficiaries of a scheme

Exclusion Criteria:

  • refusal of consent,
  • patient with a contraindication to prosthetic knee surgery:
  • any active or suspected latent infection in or around the knee joint,
  • remote foci of infection that can cause haematogenous spread on the implant site,
  • any mental or neuromuscular disorder that would create an unacceptable risk of instability of the prosthesis,
  • failure of prosthesis fixation or complications in postoperative care,
  • a bone stock compromised by a disease,
  • infection or anterior prosthetic implantation that can not provide adequate support and / or satisfactory fixation to the prosthesis,
  • skeletal immaturity,
  • severe instability of the knee joint secondary to the lack of integrity and function of the collateral ligament,
  • woman of childbearing age,
  • patient during the exclusion period of another study,
  • patient referred in Articles L1121-5 to L1121-8 of the Public Health Code

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03566875


Contacts
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Contact: Régis Pailhé, MD, PhD +33 617970492 rpailhe@chu-grenoble.fr
Contact: Emilie Chipon, PhD +33 476767313 echipon@chu-grenoble.fr

Locations
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France
University Grenoble Hospital Recruiting
Échirolles, France, 38130
Contact: Régis PI Pailhé, PhD    04 76 76 75 75    rpailhe@chu-grenoble.fr   
Contact: Emilie CEC Chipon, PhD    04 76 76 73 13    echipon@chu-grenoble.fr   
Sub-Investigator: Brice Rubens-Duval, PhD         
Sponsors and Collaborators
University Hospital, Grenoble
Clinical Investigation Centre for Innovative Technology Network
Stryker European Operations BV
Investigators
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Principal Investigator: Régis Pailhé, PhD Centre Hospitalier Universitaire Grenoble-Alpes

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03566875     History of Changes
Other Study ID Numbers: 38RC17.373
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Grenoble:
TKA robot assisted with the Stryker's MAKO™ system
surgery precision