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

Recruiting

• Conditions: Arthroplasty, Replacement, Hip

• Registration Number: NCT05686915
• Lead Sponsor: Colorado Joint Replacement

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.

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 Timeline

• Study Start: 2022-12-22
• Status Verified: 2023-01
• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-13
• Last Update Submitted: 2023-01-13
• Study First Posted: 2023-01-17
• Last Update Posted: 2023-01-17
• Primary Completion: 2023-06
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MARS MRI abnormalities	2 Years Post Revision Total Hip Replacement	Local Tissue Reactions or Fluid collections on the MARS MRI Scan

Secondary Outcome Measures

Name	Time	Method
Chromium Lab Value	2 Years Post Revision Total Hip Replacement	Chromium levels in blood
Titanium Lab Value	2 Years Post Revision Total Hip Replacement	Titanium levels in blood
Cobalt Lab Value	2 Years Post Revision Total Hip Replacement	Cobalt levels in blood

Trial Locations

Locations (1)

Colorado Joint Replacement; 🇺🇸 Denver, Colorado, United States