NCT04646096

Brief Summary

The current study is a multi-center study to assess precision and accuracy of the robotic system with new software.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 18, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 27, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

3.8 years

First QC Date

November 18, 2020

Last Update Submit

January 28, 2025

Conditions

Osteoarthritis, HipHip Disease

Keywords

Robotic-assisted Total Hip ArthroplastyMAKOplasty

Outcome Measures

Primary Outcomes (1)

  • Computed Tomography scan. Placement accuracy of acetabular cup and femoral stem

    Using computed tomography to assess placement accuracy, Measured in degrees

    6 weeks postoperatively

Secondary Outcomes (6)

  • Pelvic tilt

    Preoperatively and postoperatively at 6 weeks and 1 year

  • Virtual range-of-motion

    Preoperatively and postoperatively at 6 weeks and 1 year

  • Patient satisfaction

    1 year postoperative

  • Harris Hip Score

    preoperative and 1 year postoperative

  • Forgotten Joint Score

    1 year postoperative

  • +1 more secondary outcomes

Study Arms (1)

Mako THA 4.0 group

EXPERIMENTAL

Hip system used: femoral stem (Accolade II), acetabular cup (Trident II or MDM if necessary), femoral head (ceramic or metal head compatible with Accolade II), acetabular insert (X3 Trident II or MDM liner when using MDM cup). Mako THA 4.0 software also will be used.

Device: MAKO THA 4.0 System

Interventions

MAKO THA 4.0 SystemDEVICE

Measure how the accuracy and precision of robotic arm-assisted total hip arthroplasty (THA) for placement accuracy of implant position in both the anterior and posterior approach.. The intervention will assess the precision of the MAKO system in placing hip components according to plan. It will compare hip angles executed by the Mako system intraoperatively with the 'gold standard' of 3D computer tomography (CT) scans. The postoperative CT scan can show the precision of the MAKO system by accurately determining the location of hip replacements in patients after surgery.

Mako THA 4.0 group

Eligibility Criteria

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

You may qualify if:

  • Requires primary total hip arthroplasty surgery
  • Willing and able to comply with postoperative follow up requirements
  • at least 18 years of age
  • sign an IRB approved informed consent

You may not qualify if:

  • body mass index \>40
  • Skeletally immature
  • patient with active infection or suspected latent infection in or about joint
  • bone stock inadequate for support or fixation of the prosthesis
  • Neuromuscular disorders, muscle atrophy, or vascular deficient in the affected limb
  • Ankylosing spondylitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American Hip Institute

Des Plaines, Illinois, 60018, United States

Location

Related Publications (1)

  • Nodzo SR, Chang CC, Carroll KM, Barlow BT, Banks SA, Padgett DE, Mayman DJ, Jerabek SA. Intraoperative placement of total hip arthroplasty components with robotic-arm assisted technology correlates with postoperative implant position: a CT-based study. Bone Joint J. 2018 Oct;100-B(10):1303-1309. doi: 10.1302/0301-620X.100B10-BJJ-2018-0201.R1.

    PMID: 30295538BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Benjamin G Domb, MD

    American Hip Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

November 18, 2020

First Posted

November 27, 2020

Study Start

January 1, 2021

Primary Completion

October 10, 2024

Study Completion

October 10, 2024

Last Updated

January 29, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)