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

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Total Knee Arthroplasty

Treatments: Procedure: Total knee arthroplasty with the Stryker's MAKO™ system; Procedure: Total knee arthroplasty with mechanical ancillary

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT03566875

38RC17.373

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Total knee arthroplasty with the Stryker's MAKO™ system

Experimental group

Description:

The total knee arthroplasty is performed with Stryker's MAKO™ robotic system. It allows to place precisely the prosthetic implants.

Treatment:

Procedure: Total knee arthroplasty with the Stryker's MAKO™ system

Total knee arthroplasty with mechanical ancillary

Active Comparator group

Description:

The total knee arthroplasty is performed using a mechanical ancillary. It's the conventional method.

Treatment:

Procedure: Total knee arthroplasty with mechanical ancillary