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

NCT ID: NCT05686915

Last Updated: 2023-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-22

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Arthroplasty, Replacement, Hip

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Revision Total Hip Arthroplasty

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

MARS MRI

Intervention Type DIAGNOSTIC_TEST

metal artifact reduction sequence (MARS) MRI to assess for fluid collections, ATLRs or other abnormalities

Titanium Labs

Intervention Type DIAGNOSTIC_TEST

Labs to look at titanium levels in blood

Cobalt Labs

Intervention Type DIAGNOSTIC_TEST

Labs to look at cobalt levels in blood

Chromium Labs

Intervention Type DIAGNOSTIC_TEST

Labs to look at chromium levels in blood

Interventions

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MARS MRI

metal artifact reduction sequence (MARS) MRI to assess for fluid collections, ATLRs or other abnormalities

Intervention Type DIAGNOSTIC_TEST

Titanium Labs

Labs to look at titanium levels in blood

Intervention Type DIAGNOSTIC_TEST

Cobalt Labs

Labs to look at cobalt levels in blood

Intervention Type DIAGNOSTIC_TEST

Chromium Labs

Labs to look at chromium levels in blood

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Colorado Joint Replacement

OTHER

Sponsor Role lead

Responsible Party

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Jason Jennings

Orthopedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason M Jennings, MD

Role: PRINCIPAL_INVESTIGATOR

Colorado Joint Replacement

Locations

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Colorado Joint Replacement

Denver, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Roseann M Johnson, BS, CCRP

Role: CONTACT

303-260-2940

Facility Contacts

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Roseann Johnson

Role: primary

303-260-2940

References

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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.

Reference Type BACKGROUND
PMID: 25141843 (View on PubMed)

Other Identifiers

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1969400

Identifier Type: -

Identifier Source: org_study_id

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