NCT03566875

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 25, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2020

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

2.4 years

First QC Date

June 12, 2018

Last Update Submit

March 19, 2020

Conditions

Total Knee Arthroplasty

Keywords

TKA robot assisted with the Stryker's MAKO™ systemsurgery precision

Outcome Measures

Primary Outcomes (1)

  • 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.

    26 months

Secondary Outcomes (10)

  • To compare the mechanical axis 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 compare the operative time between the conventional surgery group and the MAKO™ assisted surgery group.

    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

  • +5 more secondary outcomes

Study Arms (2)

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.

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.

Procedure: Total knee arthroplasty with mechanical ancillary

Interventions

Total knee arthroplasty with the Stryker's MAKO™ systemPROCEDURE

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 the Stryker's MAKO™ system
Total knee arthroplasty with mechanical ancillaryPROCEDURE

The arthroplasty is performed with the mechanical ancillary refering to the the conventional method.

Total knee arthroplasty with mechanical ancillary

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 referred in Articles L1121-5 to L1121-8 of the Public Health Code

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Grenoble Hospital

Échirolles, 38130, France

RECRUITING

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Régis Pailhé, PhD

    Centre Hospitalier Universitaire Grenoble-Alpes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Régis Pailhé, MD, PhD

CONTACT

+33 617970492rpailhe@chu-grenoble.fr

Emilie Chipon, PhD

CONTACT

+33 476767313echipon@chu-grenoble.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2018

First Posted

June 25, 2018

Study Start

April 23, 2018

Primary Completion

September 23, 2020

Study Completion

September 23, 2020

Last Updated

March 20, 2020

Record last verified: 2020-03

Locations

FR(1)