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Orthopedic Implant

Dual Mobility Implants for Hip Dislocation

Phase 4
Recruiting
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary THA for a diagnosis of osteoarthritis or inflammatory arthritis in the setting of a history of prior lumbar or lumbosacral fusion performed at least 6 months prior to their THA
Be older than 18 years old
Must not have
Revision THA
Isolated cervical or thoracic fusion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years following their index surgical procedure.
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will compare two types of hip replacements to see which is better for patients at high risk for dislocation.

Who is the study for?
This trial is for adults over 75, or those with a history of lumbar fusion surgery, neuromuscular disorders, cognitive impairments, substance abuse, hip fractures, or inflammatory arthritis. It's not for people under 18 or those who've had previous hip surgeries other than lumbar fusion at least 6 months ago.
What is being tested?
The study compares two types of hip implants in high-risk patients needing total hip replacement: a traditional single-bearing implant and an advanced dual mobility implant. The goal is to see which one better prevents the dislocation of the artificial joint.
What are the potential side effects?
While specific side effects are not listed here, typical risks from hip implant surgery may include infection, pain at the site of the implant, inflammation around the joint area, dislocation of the new joint and possible need for additional surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had hip replacement for arthritis after having spine fusion surgery over 6 months ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for or have had a hip replacement revision.
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I have had spine surgery in my neck or upper back.
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I plan to have a corrective spine and pelvis surgery within a year after my hip replacement.
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I have had an infection in my hip before.
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I have been diagnosed with arthritis, bone death, or a fracture due to injury before surgery.
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I am under 18 years old.
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I have had open surgery on the hip that is now affected.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years following their index surgical procedure.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years following their index surgical procedure. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dislocations
Secondary study objectives
Complications
Radiographic signs of loosening and proper component placement.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Dual mobilityExperimental Treatment1 Intervention
Patients in this group will receive a dual mobility hip implant
Group II: Single bearing, traditional hip implantActive Control1 Intervention
Patients in this group will receive a traditional, single-bearing hip implant.

Find a Location

Who is running the clinical trial?

Keck School of Medicine of USCUNKNOWN
6 Previous Clinical Trials
620 Total Patients Enrolled
1 Trials studying Hip Dislocation
322 Patients Enrolled for Hip Dislocation
Rothman Institute OrthopaedicsOTHER
126 Previous Clinical Trials
22,172 Total Patients Enrolled
1 Trials studying Hip Dislocation
322 Patients Enrolled for Hip Dislocation
Rush University Medical CenterLead Sponsor
436 Previous Clinical Trials
248,840 Total Patients Enrolled
1 Trials studying Hip Dislocation
322 Patients Enrolled for Hip Dislocation

Media Library

Dual mobility implant (Orthopedic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT04092634 — Phase 4
Hip Dislocation Research Study Groups: Dual mobility, Single bearing, traditional hip implant
Hip Dislocation Clinical Trial 2023: Dual mobility implant Highlights & Side Effects. Trial Name: NCT04092634 — Phase 4
Dual mobility implant (Orthopedic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04092634 — Phase 4
~51 spots leftby Nov 2025
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