Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-03-03 @ 3:03 PM
Study NCT ID:
NCT04092634
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-26
First Post:
2019-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dual Mobility in "High Risk" Patients
Sponsor:
Rush University Medical Center
Organization:
Study Overview
Official Title:
Dual-mobility vs. Single-bearing Components in THA at "High Risk" for Prosthetic Dislocation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to compare clinical outcomes of patients considered to be high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single bearing design.
Detailed Description:
This study aims to compare the clinical outcomes of patients considered to be at high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single-bearing design.
We hypothesize that in primary THA patients considered to be at high risk for prosthetic dislocation, the use of dual-mobility components will be associated with a lower dislocation rate in the first year following the index procedure. We do not anticipate a difference. In other clinical outcome measures or functional outcome scores between the two cohorts.
Study Design: Randomized controlled trial with two groups: THA with dual mobility.
44 components vs THA with single-bearing designs
We hypothesize that in primary THA patients considered to be at high risk for prosthetic dislocation, the use of dual-mobility components will be associated with a lower dislocation rate in the first year following the index procedure. We do not anticipate a difference. In other clinical outcome measures or functional outcome scores between the two cohorts.
Study Design: Randomized controlled trial with two groups: THA with dual mobility.
44 components vs THA with single-bearing designs
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: