Recruiting

MARS MRI

Sponsor:

Colorado Joint Replacement

Code:

NCT05686915

Conditions

Arthroplasty, Replacement, Hip

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MARS MRI

Titanium Labs

Cobalt Labs

Chromium Labs

Study Details

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.

Conditions

Arthroplasty, Replacement, Hip

Study ID

NCT05686915

Start date

Dec 22, 2022

Status verified date

Jan, 2023

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Jun, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

55 participants

Anticipated

Interventions and Outcome Measures

Arms

Revision Total Hip Arthroplasty

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

Interventions

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

Primary outcome measure

  • MARS MRI abnormalities [ Time Frame: 2 Years Post Revision Total Hip Replacement ]

Central Contacts and Locations

Central contacts

Roseann M Johnson, BS, CCRP

303-260-2940roseannjohnson@centura.org

Locations

Colorado Joint Replacement

Recruiting

Denver, Colorado, United States, 80210

Contacts

Roseann Johnson

303-260-2940

Principal Investigator:

Jason M Jennings, MD

More Information

Sponsor

Colorado Joint Replacement

Last update posted

Jan 17, 2023

Last verified

Jan, 2023

Keywords

  • Revision
  • Titanium Sleeve

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Colorado Joint Replacement on 2023-01-17.