NCT03566875UnknownNot Applicable
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
University Hospital, Grenoble2 sites in 1 country60 target enrollmentStarted: April 23, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Difference between the actual HKA angle obtained postoperatively and the planned HKA angle preoperatively.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- To compare the mechanical axis between the conventional surgery group and the MAKO™ assisted surgery group.(26 months)
- To compare the functional results between the conventional surgery group and the MAKO™ assisted surgery group.(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(26 months)
- To evaluate the conversion rate in conventional method for patients in the MAKO™ assisted surgery group.(26 months)
- To compare the blood loss during the procedure between the conventional surgery group and the MAKO™ assisted surgery group.(26 months)
- To compare the operative time between the conventional surgery group and the MAKO™ assisted surgery group.(26 months)
- To compare between the conventional surgery group and the MAKO™ assisted surgery group the time needed to reach the hospital discharge criteria.(26 months)
- To compare intraoperative complication rates between the conventional surgery group and the MAKO™ assisted surgery group.(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)
- 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.(26 months)
Investigators
Study Sites (2)
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