THA With and Without Computer Navigation

May 15, 2023 updated by: Southeast Orthopedic Specialists

The Use of Intraoperative Fluoroscopic Computer Navigation on Hip Arthroplasty Component Position

The goal of this observational study is to compare postoperative results between patients who had total hip arthroplasty (THA) with and without the use of a computer navigation program. The main questions this study aims to answer are:

  • Can using computer navigation produce better THA implant placement?
  • Can using computer navigation make surgery more efficient?

Participant data collected include their postoperative x-rays and total operative time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of this retrospective study is to compare implant placement and operative time of patients who underwent direct anterior total hip arthroplasty with and without the use of a computer navigation program. X-rays are used to measure acetabular cup orientation, leg length discrepancy, and total operative time.

Study Type

Observational

Enrollment (Actual)

234

Contacts and Locations

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

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Southeast Orthopedic Specialists

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent DA THA with the principal investigator between August 2018 and February 2020 and received ACTIS stem and PINNACLE cup.

Description

Inclusion Criteria:

  • Patients who underwent Direct Anterior (DA) THA with the principal investigator between August 2018 and February 2020 and received ACTIS stem and PINNACLE cup with or without computer navigation

Exclusion Criteria:

  • Patients who underwent subsequent revision THA, conversion arthroplasty, hybrid procedures, experienced native or postoperative dislocations, and missing or inadequate radiographs at time of data collection.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Traditional Overlay
Subjects who underwent THA without use of computer navigation
Computer Navigation
Subjects who underwent THA with use of computer navigation
Procedure: Intraoperative Fluoroscopic Computer Navigation
Computer technology used during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cup inclination
Time Frame: 12 weeks post op
Acetabular cup orientation
12 weeks post op
Cup anteversion
Time Frame: 12 weeks post op
Acetabular cup anteversion
12 weeks post op
Leg length discrepancy
Time Frame: 12 weeks post op
Leg length discrepancy
12 weeks post op
Operative time
Time Frame: Immediate post op
Operative time in minutes
Immediate post op

Collaborators and Investigators

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

Sponsor

Southeast Orthopedic Specialists

Investigators

  • Principal Investigator: John Redmond, MD, Southeast Orthopedic Specialists

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)

February 25, 2020

Primary Completion (Actual)

October 3, 2022

Study Completion (Actual)

January 5, 2023

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 23, 2023

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPS-JMP-2019-078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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