Status unknownNCT05686915Updated Jan 17, 2023

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

An observational study in Arthroplasty, Replacement, Hip, sponsored by Colorado Joint Replacement. Status unknown at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-01-17.

Sponsored by Colorado Joint Replacement · Observational

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 55
Ages: 18 Years to 99 Years
Sex: All

Study 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.

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 studied

Arthroplasty, Replacement, Hip

Keywords

Revision
Titanium Sleeve

In context

Lead sponsor

Colorado Joint Replacement is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 99 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Observational model: Case-only
Time perspective: Prospective
Enrollment: 55 participants (estimated)
Patient registry: No

Groups and cohorts

Revision Total Hip Arthroplasty
Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve
Diagnostic Test: MARS MRI · Diagnostic Test: Titanium Labs · Diagnostic Test: Cobalt Labs · Diagnostic Test: Chromium Labs

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

What researchers measure

Primary outcomes

MARS MRI abnormalities
Local Tissue Reactions or Fluid collections on the MARS MRI Scan
Time frame: 2 Years Post Revision Total Hip Replacement

Secondary outcomes

Titanium Lab Value
Titanium levels in blood
Time frame: 2 Years Post Revision Total Hip Replacement
Chromium Lab Value
Chromium levels in blood
Time frame: 2 Years Post Revision Total Hip Replacement
Cobalt Lab Value
Cobalt levels in blood
Time frame: 2 Years Post Revision Total Hip Replacement

Study locations

1 of 1 sites recruiting

Colorado Joint Replacement
Denver, Colorado 80210, United States
- Roseann Johnson · Contact · 303-260-2940
- Jason M Jennings, MD · Principal investigator
- Adam Dreisman, MD · Sub investigator
- Nicole Quinlan, MD · Sub investigator
- Todd M Miner, MD · Sub investigator
- Charlie C Yang, MD · Sub investigator
- Douglas A Dennis, MD · Sub investigator
Recruiting

References and documents

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 ↗

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Started Dec 2022 (actual). Primary completion is estimated for Jun 2023, 6 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 6, 2023
First posted: Jan 17, 2023
StartActual: Dec 22, 2022
Primary completionEst.: Jun 2023
CompletionEst.: Dec 31, 2023
Last update: Jan 17, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05686915
Lead sponsor: Colorado Joint Replacement
Responsible party: Jason Jennings (Orthopedic Surgeon, Colorado Joint Replacement) — Principal investigator
First posted: Jan 17, 2023
Start date: Dec 22, 2022
Primary completion: Jun 2023 (estimated)
Completion: Dec 31, 2023 (estimated)
Last update: Jan 17, 2023

Study contacts

Roseann M Johnson, BS, CCRP

Contact

roseannjohnson@centura.org

303-260-2940

Jason M Jennings, MD

principal investigator · Colorado Joint Replacement

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Colorado Joint Replacement

Start the discussion