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

March 19, 2020 updated by: University Hospital, Grenoble

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Échirolles, France, 38130
        • Recruiting
        • university grenoble hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Brice Rubens-Duval, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
26 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
26 months
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.
26 months
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.
26 months
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).
26 months
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.
26 months
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.
26 months
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.
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.
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
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.
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.
26 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Stryker European Operations BV
Clinical Investigation Centre for Innovative Technology Network

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Régis Pailhé, PhD, Centre Hospitalier Universitaire Grenoble-Alpes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 23, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 38RC17.373

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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