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Multicenter Study for Robotic Arm-assisted THA 4.0 System: Hip Spine Relationship

NCT04646096 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-01-29

No results posted yet for this study

Summary

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

Conditions

  • Osteoarthritis, Hip
  • Hip Disease

Interventions

DEVICE

MAKO THA 4.0 System

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.

Sponsors & Collaborators

  • Stryker Orthopaedics

    collaborator INDUSTRY

  • Hospital for Special Surgery, New York

    collaborator OTHER

  • American Hip Institute

    lead OTHER

Principal Investigators

  • Benjamin G Domb, MD · American Hip Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2024-10-10
Completion
2024-10-10
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04646096 on ClinicalTrials.gov