Clinical trial NCT05686915: MARS MRI in Revision THA With a Ceramic Femoral Head and Titanium Sleeve
Official title: Metal Artifact Reduction Sequence MRI in Revision Total Hip Arthroplasty With a Ceramic Femoral Head and Titanium Sleeve
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthroplasty, Replacement, Hip
Keywords: Revision
Titanium Sleeve
Lead sponsor: Colorado Joint Replacement
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve

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.

Eligibility criteria: 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)

Primary outcomes:
measure: MARS MRI abnormalities
timeFrame: 2 Years Post Revision Total Hip Replacement
Secondary outcomes:
measure: Titanium Lab Value
timeFrame: 2 Years Post Revision Total Hip Replacement
measure: Chromium Lab Value
timeFrame: 2 Years Post Revision Total Hip Replacement
measure: Cobalt Lab Value
timeFrame: 2 Years Post Revision Total Hip Replacement
Other outcomes:
Locations:
city: Denver
country: United States
facility: Colorado Joint Replacement
state: Colorado
Study officials:
affiliation: Colorado Joint Replacement
name: Jason M Jennings, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.