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

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05686915
• Other study ID #: 1969400
• Status: Recruiting
• Start date: December 22, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Colorado Joint Replacement
• Contact: Roseann M Johnson, BS, CCRP
• Phone: 303-260-2940
• Email: roseannjohnson[@]centura.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 31, 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

Diagnostic Test:
• MARS MRI
metal artifact reduction sequence (MARS) MRI to assess for fluid collections, ATLRs or other abnormalities
• Titanium Labs
Labs to look at titanium levels in blood
• Cobalt Labs
Labs to look at cobalt levels in blood
• Chromium Labs
Labs to look at chromium levels in blood

Locations

Country	Name	City	State
United States	Colorado Joint Replacement	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Colorado Joint Replacement

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MARS MRI abnormalities	Local Tissue Reactions or Fluid collections on the MARS MRI Scan	2 Years Post Revision Total Hip Replacement
Secondary	Titanium Lab Value	Titanium levels in blood	2 Years Post Revision Total Hip Replacement
Secondary	Chromium Lab Value	Chromium levels in blood	2 Years Post Revision Total Hip Replacement
Secondary	Cobalt Lab Value	Cobalt levels in blood	2 Years Post Revision Total Hip Replacement