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Orthopedic Implant
Dual-Mobility vs Conventional Hip Implants for Hip Replacement
Phase 4
Waitlist Available
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
Age between 18 and 80 years
Be older than 18 years old
Must not have
Preoperative diagnosis other than osteoarthritis
Anticipated need for another joint replacement surgery within one year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial tests whether using a metal hip implant leads to higher metal levels in the blood.
Who is the study for?
This trial is for adults aged 18-80 with a BMI under 40 who need hip replacement surgery and are willing to have blood tests after the operation. It's not for those with prior hip infections, other metal implants (except dental), non-osteoarthritis diagnoses, poor kidney function, previous hip surgeries with metal devices, chromium supplement use, serious chronic diseases or expecting another joint surgery within a year.Check my eligibility
What is being tested?
The study compares two groups in primary total hip arthroplasty (THA): one receiving dual mobility components designed to reduce dislocation risk and wear; the other getting conventional single bearing surfaces. The focus is on whether the dual mobility increases metal levels in blood.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally THA can lead to pain at the site of surgery, infection risks, possible allergic reactions to materials used in implants which may affect serum metal levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My diagnosis before surgery was not osteoarthritis.
Select...
I expect to need another joint replacement within a year.
Select...
I have had hip surgery with metal parts or screws.
Select...
I am currently taking chromium supplements.
Select...
My kidney function is not normal.
Select...
I have had a hip infection in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Serum chromium levels, measures chromium level in the serum in ug/L
Serum cobalt levels, measures cobalt level in the serum in ug/L
Serum titanium levels, measures titanium level in the serum in ug/L
Secondary outcome measures
Patient reported outcome measures (survey) for SF-12 score.
Patient reported outcome measures (survey) for the Harris Hip Score
Patient reported outcome measures (survey) for the Hoos Jr. score.
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Modular Dual Mobility CohortExperimental Treatment1 Intervention
Patients in this group will receive a Taperloc femoral stem, inner ceramic femoral head (28mm), mobile polyethylene bearing, cobalt alloy liner, and G7 acetabular shell.
Group II: Conventional CohortActive Control1 Intervention
Patients in this group will receive a Taperloc femoral stem, ceramic femoral head (size 32mm for acetabular components 48/50mm; size 36mm for acetabular components > 52mm), polyethylene bearing, and G7 acetabular shell.
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Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
426 Previous Clinical Trials
157,160 Total Patients Enrolled
Zimmer BiometIndustry Sponsor
373 Previous Clinical Trials
67,145 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My diagnosis before surgery was not osteoarthritis.I expect to need another joint replacement within a year.I am between 18 and 80 years old.You have a body mass index (BMI) less than 40.My surgeon has approved me for the necessary implants.I have had hip surgery with metal parts or screws.I am currently taking chromium supplements.My kidney function is not normal.I am willing to have blood tests after surgery.I have a long-term health condition that affects my whole body.You have any metal implant in your body, except for your teeth.I have had a hip infection in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Modular Dual Mobility Cohort
- Group 2: Conventional Cohort
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
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