Arthroplasty, Replacement, Hip
Conditions
Keywords
Revision, 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.
Interventions
DIAGNOSTIC_TESTMARS MRI
metal artifact reduction sequence (MARS) MRI to assess for fluid collections, ATLRs or other abnormalities
DIAGNOSTIC_TESTTitanium Labs
Labs to look at titanium levels in blood
DIAGNOSTIC_TESTCobalt Labs
Labs to look at cobalt levels in blood
DIAGNOSTIC_TESTChromium Labs
Labs to look at chromium levels in blood
Sponsors
Colorado Joint Replacement
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MARS MRI abnormalities | 2 Years Post Revision Total Hip Replacement | Local Tissue Reactions or Fluid collections on the MARS MRI Scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Titanium Lab Value | 2 Years Post Revision Total Hip Replacement | Titanium levels in blood |
| Chromium Lab Value | 2 Years Post Revision Total Hip Replacement | Chromium levels in blood |
| Cobalt Lab Value | 2 Years Post Revision Total Hip Replacement | Cobalt levels in blood |
Countries
United States
Contacts
Primary ContactRoseann M Johnson, BS, CCRP
Outcome results
None listed