NCT05871827

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

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

Study Start

First participant enrolled

February 25, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

2.6 years

First QC Date

May 15, 2023

Last Update Submit

May 15, 2023

Conditions

Keywords

total hip arthroplasty, computer navigation

Outcome Measures

Primary Outcomes (4)

  • Cup inclination

    Acetabular cup orientation

    12 weeks post op

  • Cup anteversion

    Acetabular cup anteversion

    12 weeks post op

  • Leg length discrepancy

    Leg length discrepancy

    12 weeks post op

  • Operative time

    Operative time in minutes

    Immediate post op

Study Arms (2)

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

Interventions

Computer technology used during surgery

Computer Navigation

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southeast Orthopedic Specialists

Jacksonville, Florida, 32216, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • John Redmond, MD

    Southeast Orthopedic Specialists

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2023

First Posted

May 23, 2023

Study Start

February 25, 2020

Primary Completion

October 3, 2022

Study Completion

January 5, 2023

Last Updated

May 23, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations