NCT05686915

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 55 (estimated)
• Sponsor: Colorado Joint Replacement · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Arthroplasty, Replacement, Hip

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-12-22
• Primary completion: 2023-06-01
• Completion: 2023-12-31
• First posted: 2023-01-17
• Last updated: 2023-01-17

Locations

1 site across 1 country: United States