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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05686915
Other study ID # 1969400
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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