Actively Recruiting

Age: 21Years - 95Years
All Genders
NCT02255331

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

Led by Hospital for Special Surgery, New York · Updated on 2025-06-19

240

Participants Needed

1

Research Sites

463 weeks

Total Duration

On this page

Sponsors

H

Hospital for Special Surgery, New York

Lead Sponsor

M

Medical College of Wisconsin

Collaborating Sponsor

AI-Summary

What this Trial Is About

Patients with a total hip replacement may require early revision surgery due to an adverse local tissue reaction or bone resorption that occurs due to wear debris released from the implant. MRI provides a non-invasive biomarker for clinicians and surgeons to detect early adverse synovial reactions which may exist in the absence of clinical symptoms, thus imparting essential information for clinical management. This study will address two of the most commons causes of hip implant failure, including adverse local tissue reaction in implants not traditionally associated with adverse tissue reactions, as well as the presence of aseptic loosening and loss of implant-bone integration.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years - 95Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a total hip replacement with a ceramic component undergoing revision for any reason, including recurrent dislocation
  • Have a metal-on-polyethylene total hip replacement and have repeated dislocation
  • Have a metal-on-polyethylene total hip replacement greater than 1 year old
  • Have an infected total hip replacement (any surface bearing)
  • Have a total hip replacement with a ceramic component
  • Have a metal-on-polyethylene total hip replacement
  • Have your original or revised total hip replacement
Not Eligible

You will not qualify if you...

  • Have occupational exposure to cobalt or chromium
  • Presence of metal-on-metal or recalled implant
  • Have had a prior revision of your total hip
  • Standard contraindications to MRI
  • Have cemented components

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital for Special Surgery

New York, New York, United States, 10021

Actively Recruiting

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Research Team

M

Matthew F Koff, PhD

CONTACT

M

Mauro Miranda, MFA

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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