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NCT05871827 Clinical Trial

THA With and Without Computer Navigation

Hip Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05871827
Other study ID # DPS-JMP-2019-078
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 25, 2020
Est. completion date January 5, 2023

Study information
Verified date May 2023
Source Southeast Orthopedic Specialists
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 234
Est. completion date January 5, 2023
Est. primary completion date October 3, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Intraoperative Fluoroscopic Computer Navigation
Computer technology used during surgery

Locations
Country Name City State
United States Southeast Orthopedic Specialists Jacksonville Florida

Sponsors (1)
Lead Sponsor Collaborator
Southeast Orthopedic Specialists

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cup inclination Acetabular cup orientation 12 weeks post op
Primary Cup anteversion Acetabular cup anteversion 12 weeks post op
Primary Leg length discrepancy Leg length discrepancy 12 weeks post op
Primary Operative time Operative time in minutes Immediate post op
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