THA With and Without Computer Navigation

• Sponsor: Southeast Orthopedic Specialists (Other)
• Overall Status: Completed
• CT.gov ID: NCT05871827
• Collaborator: (none)
• Enrollment: 234
• Location: 1
• Actual Duration (Months): 34.3
• Patients Per Site Per Month: 6.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Osteoarthritis; Avascular Necrosis of Hip	Procedure: Intraoperative Fluoroscopic Computer Navigation

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 Design

• Study Type: Observational
• Actual Enrollment: 234 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: The Use of Intraoperative Fluoroscopic Computer Navigation on Hip Arthroplasty Component Position
• Actual Study Start Date: Feb 25, 2020
• Actual Primary Completion Date: Oct 3, 2022
• Actual Study Completion Date: Jan 5, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Cup inclination [12 weeks post op]

   Acetabular cup orientation

2. Cup anteversion [12 weeks post op]

   Acetabular cup anteversion

3. Leg length discrepancy [12 weeks post op]

   Leg length discrepancy

4. Operative time [Immediate post op]

   Operative time in minutes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southeast Orthopedic Specialists	Jacksonville	Florida	United States	32216

Sponsors and Collaborators

• Southeast Orthopedic Specialists

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Southeast Orthopedic Specialists
• ClinicalTrials.gov Identifier: NCT05871827
• Other Study ID Numbers: DPS-JMP-2019-078
• First Posted: May 23, 2023
• Last Update Posted: May 23, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Southeast Orthopedic Specialists: total hip arthroplasty, computer navigation
• Additional relevant MeSH terms: Osteoarthritis, Hip; Necrosis

Study Results

No Results Posted as of May 23, 2023