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Search / Trial NCT02255331

Using MRI To Detect Soft Tissue Reactions And Implant Integration As Related To Implant Modularity

Launched by HOSPITAL FOR SPECIAL SURGERY, NEW YORK · Oct 1, 2014

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Arthroplasty Replacement Hip Mri

ClinConnect Summary

This clinical trial is studying how MRI (a type of imaging that uses magnets and radio waves) can help detect issues with hip implants, particularly problems that can arise without obvious symptoms. The research focuses on two common causes of hip implant failure: local tissue reactions and loosening of the implant from the bone. By identifying these problems early, doctors can better manage patient care and decide if any additional procedures, such as revision surgery, might be needed.

To participate in this study, you may be eligible if you have had a total hip replacement with certain types of components, especially if you're experiencing complications like dislocations or infections. The trial is open to all genders and includes those aged between 70 and 98. Participants will undergo MRI scans to check for any early signs of tissue reactions or implant issues. It’s important to note that individuals with certain prior exposures or specific types of implants may not be eligible. Overall, this trial aims to improve the understanding of hip implant performance and enhance patient outcomes.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Cohort #1:
  • 1. Have a total hip replacement with a ceramic component undergoing revision for any reason, including recurrent dislocation.
  • 2. Have a metal-on-polyethylene total hip replacement and have repeated dislocation, or
  • 3. Have a metal-on-polyethylene total hip replacement greater than 1 year old, or
  • 4. Have an infected total hip replacement (any surface bearing)
  • Cohort #2:
  • 1. Have a total hip replacement with a ceramic component.
  • 2. Have a metal-on-polyethylene total hip replacement.
  • 3. Have your original or revised total hip replacement.
  • Exclusion Criteria:
  • Cohort #1:
  • 1. Have occupational exposure to cobalt or chromium
  • 2. Presence of MOM or recalled implant
  • 3. Have had a prior revision of your total hip
  • 4. Standard contra-indications to MRI
  • Cohort #2:
  • 1. Have occupational exposure to cobalt or chromium.
  • 2. Have cemented components.
  • 3. Presence of a metal-on-metal or recalled implant.
  • 4. Standard contra-indications to MRI.

About Hospital For Special Surgery, New York

The Hospital for Special Surgery (HSS) in New York is a world-renowned institution specializing in orthopedic surgery, rheumatology, and rehabilitation. Recognized for its commitment to advancing medical research and improving patient outcomes, HSS serves as a leading clinical trial sponsor, facilitating innovative studies that explore cutting-edge treatments and therapies. With a team of expert clinicians and researchers, HSS aims to enhance clinical practices through rigorous scientific inquiry, ultimately contributing to the advancement of musculoskeletal health and patient care on a global scale.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Matthew F Koff, PhD

Principal Investigator

Hospital for Special Surgery, New York

Hollis G Potter, MD

Principal Investigator

Hospital for Special Surgery, New York

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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