The Ability Of MRI To Detect Adverse Local Tissue Reaction And Implant Integration As A Function Of Hip Implant Modularity
Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 95
Healthy Volunteers: f
View:
⁃ Cohort #1:
• 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, or
• Have a metal-on-polyethylene total hip replacement greater than 1 year old, or
• Have an infected total hip replacement (any surface bearing)
⁃ Cohort #2:
• 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.
Locations
United States
New York
Hospital for Special Surgery
RECRUITING
New York
Contact Information
Primary
Matthew F Koff, PhD
koffm@hss.edu
212-774-2103
Backup
Mauro Miranda, MFA
mirandam@hss.edu
212-774-1979
Time Frame
Start Date:2017-09-15
Estimated Completion Date:2026-08
Participants
Target number of participants:240
Treatments
Retrieval Analysis
You qualify for this Retrieval Analysis study if you:~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)~You do not qualify for this arm of the study if you:~1. Have occupational exposure to cobalt or chromium~2. Presence of a metal-on-metal (MOM) implant, or a recalled implant~3. Have had a prior revision of your total hip~4. Standard contra-indications to MRI (e.g. cardiac pacemaker, etc.)
Longitudinal Evaluation
You qualify for this arm of the study if you:~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.~You do not qualify for this arm of the study if you:~1. Have occupational exposure to cobalt or chromium~2. Have cemented components.~3. Presence of a metal-on-metal (MOM) implant, or a recalled implant~4. Standard contra-indications to MRI (e.g. cardiac pacemaker, etc.)