MARS MRI in Revision THA With a Ceramic Femoral Head and Titanium Sleeve

January 13, 2023 updated by: Jason Jennings, Colorado Joint Replacement

Metal Artifact Reduction Sequence MRI in Revision Total Hip Arthroplasty With a Ceramic Femoral Head and Titanium Sleeve

Revision total hip replacement using a ceramic head utilizes a titanium sleeve which introduced another articulation into the system that may lead to a local soft tissue reaction. The purpose of this study is to determine the frequency, size and types of MRI documented local tissue reactions in individuals doing well after a revision total hip replacement and ceramic bearing surface that utilizes a titanium sleeve.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Metal-on-metal total hip arthroplasty (THA) were heralded as a solution for two of the most common problems in hip arthroplasty in the last decade, instability and osteolysis. Unfortunately, their failures have led to diminished enthusiasm for this bearing surface. Adverse local tissue reactions (ATLRs) have been well documented as a means of pain and failure in this population. A recent report revealed that the most commonly used bearing surface in total hip arthroplasty, metal-on-polyethylene, may have up to a 28% incidence of MRI abnormalities in asymptomatic hips. Revision THA using a ceramic head utilizes a titanium sleeve which introduced another articulation into the system that may lead to a local soft tissue reaction. The purpose of this study is to determine the frequency, size and types of MRI documented local tissue reactions in asymptomatic individuals after a revision THA and ceramic bearing surface that utilizes a titanium sleeve. To our knowledge, this has not been studied previously and may provide important baseline features of this diagnostic tool with this particular bearing surface. We hypothesize that there will be fluid collections in a small but clinically significant portion of asymptomatic patients.

Study Type

Observational

Enrollment (Anticipated)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80210
        • Recruiting
        • Colorado Joint Replacement
        • Contact:
          • Roseann Johnson
          • Phone Number: 303-260-2940
        • Principal Investigator:
          • Jason M Jennings, MD
        • Sub-Investigator:
          • Adam Dreisman, MD
        • Sub-Investigator:
          • Nicole Quinlan, MD
        • Sub-Investigator:
          • Todd M Miner, MD
        • Sub-Investigator:
          • Charlie C Yang, MD
        • Sub-Investigator:
          • Douglas A Dennis, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve

Description

Inclusion Criteria:

  • Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve
  • Patient whose age ranges from 18-99
  • Patients who are not experiencing groin pain, thigh pain, or pain with ROM of the hip
  • Patients who are at least 2 years after a revision THA
  • Acetabular implant (cup) was placed in the appropriate position
  • Patients with a Harris Hip Score of >90

Exclusion Criteria:

  • Patients who do not meet the above criteria
  • Patients unable to have an MRI (i.e. pacemaker, metal implants or issues with claustrophobia requiring sedation)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Revision Total Hip Arthroplasty
Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve
Diagnostic test: MARS MRI
metal artifact reduction sequence (MARS) MRI to assess for fluid collections, ATLRs or other abnormalities
Diagnostic test: Titanium Labs
Labs to look at titanium levels in blood
Diagnostic test: Cobalt Labs
Labs to look at cobalt levels in blood
Diagnostic test: Chromium Labs
Labs to look at chromium levels in blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MARS MRI abnormalities
Time Frame: 2 Years Post Revision Total Hip Replacement
Local Tissue Reactions or Fluid collections on the MARS MRI Scan
2 Years Post Revision Total Hip Replacement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Titanium Lab Value
Time Frame: 2 Years Post Revision Total Hip Replacement
Titanium levels in blood
2 Years Post Revision Total Hip Replacement
Chromium Lab Value
Time Frame: 2 Years Post Revision Total Hip Replacement
Chromium levels in blood
2 Years Post Revision Total Hip Replacement
Cobalt Lab Value
Time Frame: 2 Years Post Revision Total Hip Replacement
Cobalt levels in blood
2 Years Post Revision Total Hip Replacement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colorado Joint Replacement

Investigators

  • Principal Investigator: Jason M Jennings, MD, Colorado Joint Replacement

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

January 6, 2023

First Submitted That Met QC Criteria

January 13, 2023

First Posted (Estimate)

January 16, 2023

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1969400

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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