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Dual-Mobility vs Conventional Hip Implants for Hip Replacement
Study Summary
This trial tests whether using a metal hip implant leads to higher metal levels in the blood.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Modular Dual Mobility Cohort
- Group 2: Conventional Cohort
- 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.
- 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
Am I eligible to contribute to this clinical investigation?
"This research project is enrolling 52 persons aged 18 to 80 with beryllium. To be eligible, participants must also have a Body Mass Index below 40 and qualify for the essential implants as evaluated by their physician."
What potential risks come with Dual mobility cohort implementation in patients?
"Leveraging the safety data from Phase 4 trials, we at Power rate dual mobility cohort with a score of 3."
Does this trial recruit participants of ages under 30?
"This trial is enrolling individuals who have attained the legal age of consent and are no older than 80 years old."
Are there any vacancies that participants can fill in this experiment?
"According to the information published on clinicaltrials.gov, this particular medical study has ceased enrolling patients; its first post date being December 15th 2017 and last edit taking place October 27th 2022. Nevertheless, there are other trials actively recruiting participants at present."
What objectives is this experiment attempting to fulfill?
"For the duration of this trial, roughly up to 5 years, serum titanium levels will be tracked as a primary outcome measure (measured in ug/L). Secondary objectives include patient reported outcomes using SF-12, SANE and HOOS Jr. surveys - with higher scores indicating better results (scores up to 100 are achievable)."
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