Total Knee Arthroplasty Robot Assisted With MAKO™ Robotic System Compared to the Conventional Total Knee Arthroplasty by Mechanical Ancillary
NCT ID: NCT03566875
Last Updated: 2020-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2018-04-23
2020-09-23
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
Total knee arthroplasty with mechanical ancillary
The total knee arthroplasty is performed using a mechanical ancillary. It's the conventional method.
Total knee arthroplasty with mechanical ancillary
The arthroplasty is performed with the mechanical ancillary refering to the the conventional method.
Interventions
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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.
Total knee arthroplasty with mechanical ancillary
The arthroplasty is performed with the mechanical ancillary refering to the the conventional method.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Clinical Investigation Centre for Innovative Technology Network
NETWORK
Stryker Orthopaedics
INDUSTRY
University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Régis Pailhé, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire Grenoble-Alpes
Locations
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University Grenoble Hospital
Échirolles, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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38RC17.373
Identifier Type: -
Identifier Source: org_study_id
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