Total Knee ArthroplastyTKA-MAKONCT03566875
Total Knee Arthroplasty Robot Assisted With MAKO™ Robotic System Compared to the Conventional Total Knee Arthroplasty by Mechanical Ancillary
A study testing Total knee arthroplasty with the Stryker's MAKO™ system and Total knee arthroplasty with mechanical ancillary in people with Total Knee Arthroplasty, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Total knee arthroplasty with the Stryker's MAKO™ system and Total knee arthroplasty with mechanical ancillary
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 23 Apr 2018to 23 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
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- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Grenoble Hospital
Échirolles, 38130
Régis PI Pailhé, PhD, 04 76 76 75 75, rpailhe@chu-grenoble.fr
Emilie CEC Chipon, PhD, 04 76 76 73 13, echipon@chu-grenoble.fr
About this study
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
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
- Conditions
- Total Knee Arthroplasty
- Being tested
- Total knee arthroplasty with the Stryker's MAKO™ system, Total knee arthroplasty with mechanical ancillary
- Keywords
- TKA robot assisted with the Stryker's MAKO™ system, surgery precision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplasty with the Stryker's MAKO™ systemProcedure or surgery
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 ancillaryProcedure or surgery
The arthroplasty is performed with the mechanical ancillary refering to the the conventional method.
| Study group | Role | What they receive |
|---|---|---|
| Total knee arthroplasty with the Stryker's MAKO™ system | Experimental | The total knee arthroplasty is performed with Stryker's MAKO™ robotic system. It allows to place precisely the prosthetic implants. Receives: Procedure: Total knee arthroplasty with the Stryker's MAKO™ system |
| Total knee arthroplasty with mechanical ancillary | Active comparator | The total knee arthroplasty is performed using a mechanical ancillary. It's the conventional method. Receives: Procedure: Total knee arthroplasty with mechanical ancillary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the actual HKA angle obtained postoperatively and the planned HKA angle preoperatively.
HKA (Hip-Knee-Ankle). Angles in degrees are obtained from preoperative 3D scanner and postoperative 3D scanner on day 7.
Measured: 26 months
Secondary outcomes (10)
To compare the mechanical axis between the conventional surgery group and the MAKO™ assisted surgery group.
Mechanical axis (in degree) evaluated from the post-operative 3D computed tomography on the day 7.
Measured: 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
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.
Measured: 26 months
To compare the operative time between the conventional surgery group and the MAKO™ assisted surgery group.
Duration (in minutes) between the time of the last stitch and the time of the first incision.
Measured: 26 months
To evaluate the conversion rate in conventional method for patients in the MAKO™ assisted surgery group.
Conversion number to conventional method.
Measured: 26 months
To compare the blood loss during the procedure between the conventional surgery group and the MAKO™ assisted surgery group.
Blood loss in liter according to the BRECHER formula (see Appendix E).
Measured: 26 months
To compare between the conventional surgery group and the MAKO™ assisted surgery group the time needed to reach the hospital discharge criteria.
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.
Measured: 26 months
To compare the functional results between the conventional surgery group and the MAKO™ assisted surgery group.
KSS, KOOS and EQ5D-3L scores at inclusion, then at 3 months, 6 months, and 1 year postoperatively.
Measured: 26 months
To compare intraoperative complication rates between the conventional surgery group and the MAKO™ assisted surgery group.
Number of intraoperative complications. The complications are classified according to the following classification: light grade 1; moderate level 2; severe grade 3.
Measured: 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.
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
Measured: 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.
- for the surgical installation step: duration in minutes between the start of installation time (= end of anesthesia) and the time of first incision;
- 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;
- 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.
Measured: 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start23 Apr 2018
- Primary completion23 Sep 2020 (estimated)
- Study completion23 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network, Stryker Orthopaedics
- Responsible party
- Sponsor
- Investigators
- Régis Pailhé, PhD, Principal investigator, Centre Hospitalier Universitaire Grenoble-Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566875
- Sponsor's protocol ID
- 38RC17.373
- Acronym
- TKA-MAKO
- Status last verified
- Mar 2020
- First submitted
- 12 Jun 2018
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03566875
- Acronym / sponsor ID
- TKA-MAKO / 38RC17.373
- Conditions
- Total Knee Arthroplasty
- Keywords
- TKA robot assisted with the Stryker's MAKO™ system, surgery precision
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network, Stryker Orthopaedics
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 23 Sep 2020 (estimated)
- Study completion
- 23 Sep 2020 (estimated)
- First posted
- 25 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total knee arthroplasty with the Stryker's MAKO™ system | Experimental | Procedure: Total knee arthroplasty with the Stryker's MAKO™ systemThe total knee arthroplasty is performed with Stryker's MAKO™ robotic system. It allows to place precisely the prosthetic implants. |
| Total knee arthroplasty with mechanical ancillary | Active comparator | Procedure: Total knee arthroplasty with mechanical ancillaryThe total knee arthroplasty is performed using a mechanical ancillary. It's the conventional method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total knee arthroplasty with the Stryker's MAKO™ systemThe 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. | Procedure or surgery | Total knee arthroplasty with the Stryker's MAKO™ system |
| Total knee arthroplasty with mechanical ancillaryThe arthroplasty is performed with the mechanical ancillary refering to the the conventional method. | Procedure or surgery | Total knee arthroplasty with mechanical ancillary |
Primary outcome
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.
10 secondary outcomes
To compare the mechanical axis between the conventional surgery group and the MAKO™ assisted surgery group.
Time frame: 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
To compare the operative time between the conventional surgery group and the MAKO™ assisted surgery group.
Time frame: 26 months
To evaluate the conversion rate in conventional method for patients in the MAKO™ assisted surgery group.
Time frame: 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
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
To compare the functional results between the conventional surgery group and the MAKO™ assisted surgery group.
Time frame: 26 months
To compare intraoperative complication rates between the conventional surgery group and the MAKO™ assisted surgery group.
Time frame: 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Régis Pailhé, PhD principal investigator
Centre Hospitalier Universitaire Grenoble-Alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty with the Stryker's MAKO™ system and Total knee arthroplasty with mechanical ancillary in people with Total Knee Arthroplasty, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Régis Pailhé, MD, PhD (+33 617970492, rpailhe@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between the actual HKA angle obtained postoperatively and the planned HKA angle preoperatively. (time frame: 26 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.