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Not Applicable

Hip Replacement Monitoring for Hip Pain

N/A

Waitlist Available

Research Sponsored by Hospital for Special Surgery, New York

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing whether or not metal ion levels in patients who have had a total hip replacement using a Trident II Tritanium system, MDM liner, and ceramic head are normal one year post-op.

Who is the study for?

This trial is for individuals aged 21-80 with hip pain due to non-inflammatory degenerative joint disease, who are about to have a total hip replacement using the Stryker Trident II system. They must be able to attend follow-up evaluations and have signed an IRB-approved consent form. It excludes international patients, those with bilateral hip replacements or other joint replacements, prisoners, and anyone not consented in the CORRe database.Check my eligibility

What is being tested?

The study measures levels of metal ions (cobalt, chromium, titanium) in the blood of patients before and one year after receiving a total hip replacement with Trident II Tritanium cups, MDM liner, and ceramic head. The goal is to confirm that metal ion levels remain normal post-surgery.See study design

What are the potential side effects?

While this study does not involve medication interventions that typically cause side effects, drawing blood can sometimes result in bruising at the puncture site or fainting.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Metal Ion levels before and 1 year after a total hip replacement with a Trident II Cup

Trial Design

2Treatment groups

Experimental Treatment

Group I: Preoperative GroupExperimental Treatment1 Intervention

This is a group of 30 patients who will be undergoing a total hip replacement with a Trident II shell. This group of patients will have their bloods drawn and tested for metal ion levels at a preoperative visit.

Group II: 1 year Postoperative GroupExperimental Treatment1 Intervention

This is the same group of 30 patients who are now one year post op after having a total hip replacement with a Trident II shell. This group of patients will have their bloods drawn and tested for metal ion levels at their one year visit.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor

243 Previous Clinical Trials

59,334 Total Patients Enrolled

2 Trials studying Hip Pain

72 Patients Enrolled for Hip Pain

Stryker NordicIndustry Sponsor

32 Previous Clinical Trials

4,065 Total Patients Enrolled

Media Library

Total Hip Replacement (Not Applicable) Clinical Trial Eligibility Overview. Trial Name: NCT03433742 — N/A

Hip Pain Research Study Groups: Preoperative Group, 1 year Postoperative Group

Hip Pain Clinical Trial 2023: Total Hip Replacement Highlights & Side Effects. Trial Name: NCT03433742 — N/A

Total Hip Replacement (Not Applicable) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03433742 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this experiment currently open to new volunteers?

"Per clinicaltrials.gov, this study is no longer recruiting participants as it was initially posted on February 22nd 2018 and last edited July 27th 2022. Thankfully, there are other trials seeking patients at present time."

Answered by AI

Could individuals aged 40 and above enroll in this trial?

"This medical trial seeks to enroll patients above the age of majority and below 80 years old."

Answered by AI

What criteria must an individual meet to be eligible for participating in this clinical research?

"To be eligible for the trial, patients experiencing hip pain must fall between 21 and 80 years old. The study is currently recruiting approximately 30 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Metal Ion Levels in Stryker Trident II Tritanium System With Modular Dual Mobility (MDM) Liner, Ceramic Head, and SecurFit Advanced Stems

2018. "Metal Ion Levels in Stryker Trident II Tritanium System With Modular Dual Mobility (MDM) Liner, Ceramic Head, and SecurFit Advanced Stems". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03433742.