Using MRI to assess tissue reactions and implant integration in hip replacements
The Ability Of MRI To Detect Adverse Local Tissue Reaction And Implant Integration As A Function Of Hip Implant Modularity
This study is testing if MRI can help find problems with hip replacements and how well the implants are working in patients who need revision surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 21 Years to 95 Years |
| Sex | All |
| Sponsor | Hospital for Special Surgery, New York Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT02255331 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of MRI in detecting adverse local tissue reactions and assessing implant integration in patients with total hip replacements. It focuses on identifying complications related to different implant designs, particularly those not traditionally associated with adverse reactions. By correlating MRI findings with biopsy results and surgical observations, the study seeks to enhance clinical management of hip arthroplasty failures. The research will involve patients undergoing revision surgery for various reasons, including recurrent dislocation and infection.
Who should consider this trial
Good fit: Ideal candidates include patients with total hip replacements experiencing complications such as dislocation or infection, particularly those with ceramic or metal-on-polyethylene components.
Not a fit: Patients with occupational exposure to cobalt or chromium, or those with metal-on-metal implants, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection of complications in hip implants, potentially reducing the need for revision surgeries.
How similar studies have performed: Other studies have shown promising results using MRI for detecting complications in hip arthroplasty, suggesting this approach is both relevant and potentially effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- Hospital for Special Surgery — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Matthew F Koff, PhD — Hospital for Special Surgery, New York
- Study coordinator: Matthew F Koff, PhD
- Email: koffm@hss.edu
- Phone: 212-774-2103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.