THA With and Without Computer Navigation | NCT05871827

Studies
THA With and Without Computer Navigation

NCT05871827

Sponsor

Southeast Orthopedic Specialists

Status

Completed

Last Update Posted

May 23, 2023Actual

Enrollment

234Actual

Phase

Not provided

Conditions

Hip Osteoarthritis
Avascular Necrosis of Hip

Interventions

Intraoperative Fluoroscopic Computer Navigation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 25, 2020Actual

Primary Completion Date

Oct 3, 2022Actual

Completion Date

Jan 5, 2023Actual

First Submitted Date

May 15, 2023

First Submission Date that Met QC Criteria

May 15, 2023

First Posted Date

May 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2023

Last Update Posted Date

May 23, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

234Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Intraoperative Fluoroscopic Computer Navigation	Procedure	Computer technology used during surgery	Computer Navigation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Redmond, MD	Southeast Orthopedic Specialists	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southeast Orthopedic Specialists		Jacksonville	Florida	32216	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015207	Osteoarthritis, Hip

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided