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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years following their index surgical procedure.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I had hip replacement for arthritis after having spine fusion surgery over 6 months ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years following their index surgical procedure.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years following their index surgical procedure.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dislocations
Secondary outcome measures
Complications
Radiographic signs of loosening and proper component placement.
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
5 Previous Clinical Trials
298 Total Patients Enrolled
Rothman Institute OrthopaedicsOTHER
121 Previous Clinical Trials
21,166 Total Patients Enrolled
1 Trials studying Hip Dislocation
322 Patients Enrolled for Hip Dislocation
Rush University Medical CenterLead Sponsor
422 Previous Clinical Trials
163,119 Total Patients Enrolled
1 Trials studying Hip Dislocation
322 Patients Enrolled for Hip Dislocation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had spine and pelvis surgery less than 6 months ago.I am scheduled for or have had a hip replacement revision.I have had spine surgery in my neck or upper back.I had hip replacement for arthritis after having spine fusion surgery over 6 months ago.I am at high risk for hip dislocation due to one or more specific health issues.I plan to have a corrective spine and pelvis surgery within a year after my hip replacement.I have had an infection in my hip before.I have been diagnosed with arthritis, bone death, or a fracture due to injury before surgery.I am under 18 years old.I have had open surgery on the hip that is now affected.
Research Study Groups:
This trial has the following groups:- Group 1: Dual mobility
- Group 2: Single bearing, traditional hip implant
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being enrolled in this research study?
"Correct. The clinicaltrials.gov website confirms that the medical research trial, which first appeared on November 1st 2017, is actively seeking participants right now. A total of 412 patients will be recruited from 4 different sites."
Answered by AI
Have Dual mobility implants attained regulatory authorization from the FDA?
"The safety of dual mobility implants is rated a 3 due to the fact it has already been approved in Phase 4 trials."
Answered by AI
Are there still openings available for participation in this investigation?
"Affirmative. The information published on clinicaltrials.gov indicates that this medical study is actively looking for participants, having been posted in November 1st 2017 and last updated October 27th 2022. 412 individuals must be enrolled at 4 different sites to complete the trial."
Answered by AI
How many facilities are presently housing this clinical investigation?
"Several medical institutions are participating in this trial, including Rush University Medical Center of Chicago, Illinois; New york University Medical Center in Manhattan; and Rothman Orthopaedic Institute of Philadelphia, Pennsylvania."
Answered by AI
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