Arthroplasty, Replacement, HipNCT05686915
MARS MRI in Revision THA With a Ceramic Femoral Head and Titanium Sleeve
An observational study of Arthroplasty, Replacement, Hip, run by Colorado Joint Replacement at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Arthroplasty, Replacement, Hip
- What is being tested?
- MARS MRI, Titanium Labs and Cobalt Labs
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2022to 20 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metal Artifact Reduction Sequence MRI in Revision Total Hip Arthroplasty With a Ceramic Femoral Head and Titanium Sleeve
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.
Read the 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.
- Conditions
- Arthroplasty, Replacement, Hip
- Being tested
- MARS MRI, Titanium Labs, Cobalt Labs, Chromium Labs
- Keywords
- Revision, Titanium Sleeve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MARS MRIDiagnostic test
metal artifact reduction sequence (MARS) MRI to assess for fluid collections, ATLRs or other abnormalities
Titanium LabsDiagnostic test
Labs to look at titanium levels in blood
Cobalt LabsDiagnostic test
Labs to look at cobalt levels in blood
Chromium LabsDiagnostic test
Labs to look at chromium levels in blood
| Study group | Role | What they receive |
|---|---|---|
| Revision Total Hip Arthroplasty | Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve Receives: Diagnostic Test: MARS MRI; Diagnostic Test: Titanium Labs; Diagnostic Test: Cobalt Labs; Diagnostic Test: Chromium Labs |
What is being measured
The primary outcome is the main question the study is designed to answer.
MARS MRI abnormalities
Local Tissue Reactions or Fluid collections on the MARS MRI Scan
Measured: 2 Years Post Revision Total Hip Replacement
Secondary outcomes (3)
Titanium Lab Value
Titanium levels in blood
Measured: 2 Years Post Revision Total Hip Replacement
Chromium Lab Value
Chromium levels in blood
Measured: 2 Years Post Revision Total Hip Replacement
Cobalt Lab Value
Cobalt levels in blood
Measured: 2 Years Post Revision Total Hip Replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start22 Dec 2022
- Primary completion16 Nov 2023
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado Joint Replacement
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Jennings, Colorado Joint Replacement
- Investigators
- Jason M Jennings, MD, Principal investigator, Colorado Joint Replacement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686915
- Sponsor's protocol ID
- 1969400
- Status last verified
- Nov 2026
- First submitted
- 6 Jan 2023
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25141843
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metal Artifact Reduction Sequence MRI in Revision Total Hip Arthroplasty With a Ceramic Femoral Head and Titanium Sleeve
- ClinicalTrials.gov ID
- NCT05686915
- Acronym / sponsor ID
- 1969400
- Conditions
- Arthroplasty, Replacement, Hip
- Keywords
- Revision, Titanium Sleeve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Colorado Joint ReplacementUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Revision Total Hip Arthroplasty | – | Diagnostic Test: MARS MRI, Diagnostic Test: Titanium Labs, Diagnostic Test: Cobalt Labs, Diagnostic Test: Chromium LabsPatients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MARS MRImetal artifact reduction sequence (MARS) MRI to assess for fluid collections, ATLRs or other abnormalities | Diagnostic test | Revision Total Hip Arthroplasty |
| Titanium LabsLabs to look at titanium levels in blood | Diagnostic test | Revision Total Hip Arthroplasty |
| Cobalt LabsLabs to look at cobalt levels in blood | Diagnostic test | Revision Total Hip Arthroplasty |
| Chromium LabsLabs to look at chromium levels in blood | Diagnostic test | Revision Total Hip Arthroplasty |
Primary outcome
MARS MRI abnormalities
Time frame: 2 Years Post Revision Total Hip Replacement
Local Tissue Reactions or Fluid collections on the MARS MRI Scan
3 secondary outcomes
Titanium Lab Value
Time frame: 2 Years Post Revision Total Hip Replacement
Chromium Lab Value
Time frame: 2 Years Post Revision Total Hip Replacement
Cobalt Lab Value
Time frame: 2 Years Post Revision Total Hip Replacement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 25141843Fehring 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason M Jennings, MD principal investigator
Colorado Joint Replacement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, Replacement, Hip, run by Colorado Joint Replacement at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MARS MRI abnormalities (time frame: 2 Years Post Revision Total Hip Replacement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05686915, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.