MARS MRI in Revision THA With a Ceramic Femoral Head and Titanium Sleeve
Metal Artifact Reduction Sequence MRI in Revision Total Hip Arthroplasty With a Ceramic Femoral Head and Titanium Sleeve
1 other identifier
observational
55
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 22, 2022
CompletedFirst Submitted
Initial submission to the registry
January 6, 2023
CompletedFirst Posted
Study publicly available on registry
January 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJanuary 17, 2023
January 1, 2023
5 months
January 6, 2023
January 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MARS MRI abnormalities
Local Tissue Reactions or Fluid collections on the MARS MRI Scan
2 Years Post Revision Total Hip Replacement
Secondary Outcomes (3)
Titanium Lab Value
2 Years Post Revision Total Hip Replacement
Chromium Lab Value
2 Years Post Revision Total Hip Replacement
Cobalt Lab Value
2 Years Post Revision Total Hip Replacement
Study Arms (1)
Revision Total Hip Arthroplasty
Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve
Interventions
metal artifact reduction sequence (MARS) MRI to assess for fluid collections, ATLRs or other abnormalities
Eligibility Criteria
Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Colorado Joint Replacement
Denver, Colorado, 80210, United States
Related Publications (1)
Fehring TK, Fehring K, Odum SM. Metal artifact reduction sequence MRI abnormalities occur in metal-on-polyethylene hips. Clin Orthop Relat Res. 2015 Feb;473(2):574-80. doi: 10.1007/s11999-014-3873-6.
PMID: 25141843BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Jason M Jennings, MD
Colorado Joint Replacement
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Orthopedic Surgeon
Study Record Dates
First Submitted
January 6, 2023
First Posted
January 17, 2023
Study Start
December 22, 2022
Primary Completion
June 1, 2023
Study Completion
December 31, 2023
Last Updated
January 17, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share