RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Ability Of MRI To Detect Adverse Local Tissue Reaction And Implant Integration As A Function Of Hip Implant Modularity

Quick Facts

Study Start:2017-09-15
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02255331

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 95 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Have a total hip replacement with a ceramic component undergoing revision for any reason, including recurrent dislocation.
  2. 2. Have a metal-on-polyethylene total hip replacement and have repeated dislocation, or
  3. 3. Have a metal-on-polyethylene total hip replacement greater than 1 year old, or
  4. 4. Have an infected total hip replacement (any surface bearing)
  5. 1. Have a total hip replacement with a ceramic component.
  6. 2. Have a metal-on-polyethylene total hip replacement.
  7. 3. Have your original or revised total hip replacement.
  1. 1. Have occupational exposure to cobalt or chromium
  2. 2. Presence of MOM or recalled implant
  3. 3. Have had a prior revision of your total hip
  4. 4. Standard contra-indications to MRI
  5. 1. Have occupational exposure to cobalt or chromium.
  6. 2. Have cemented components.
  7. 3. Presence of a metal-on-metal or recalled implant.
  8. 4. Standard contra-indications to MRI.

Contacts and Locations

Study Contact

Matthew F Koff, PhD
CONTACT
212-774-2103
koffm@hss.edu
Mauro Miranda, MFA
CONTACT
212-774-1979
mirandam@hss.edu

Principal Investigator

Matthew F Koff, PhD
PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York
Hollis G Potter, MD
PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York

Study Locations (Sites)

Hospital for Special Surgery
New York, New York, 10021
United States

Collaborators and Investigators

Sponsor: Hospital for Special Surgery, New York

  • Matthew F Koff, PhD, PRINCIPAL_INVESTIGATOR, Hospital for Special Surgery, New York
  • Hollis G Potter, MD, PRINCIPAL_INVESTIGATOR, Hospital for Special Surgery, New York

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-09-15
Study Completion Date2025-08

Study Record Updates

Study Start Date2017-09-15
Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

  • Arthroplasty
  • Replacement
  • Hip
  • MRI

Additional Relevant MeSH Terms

  • Complications; Arthroplasty
  • Complications; Arthroplasty, Mechanical