Using MRI To Detect Soft Tissue Reactions And Implant Integration As Related To Implant Modularity
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 21 - 95 |
| Updated: | 10/7/2018 |
| Start Date: | September 15, 2017 |
| End Date: | August 2025 |
| Contact: | Matthew F Koff, PhD |
| Email: | koffm@hss.edu |
| Phone: | 212-774-2103 |
The Ability Of MRI To Detect Adverse Local Tissue Reaction And Implant Integration As A Function Of Hip Implant Modularity
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.
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.
Total hip arthroplasty (THA) has been successful in achieving pain reduction, but recent
concerns have been raised regarding the development of adverse local tissue reactions
(ALTRs). Our group has previously found that: 1) Magnetic resonance imaging (MRI) can detect
and distinguish wear debris from THA; 2) MRI is sensitive to ALTR damage from different
articulating surfaces; and 3) variable host-mediated response to wear debris mounts distinct
morphologic patterns on MRI. There is continued interest in the evaluation of soft tissues
near THAs as traditional THA designs, including metal-on-polyethylene (MOP) and
ceramic-on-polyethylene (COP) bearing surfaces, have recently been implicated in ALTRs. It is
believed that fretting and corrosion at the head-neck junction is responsible for ALTRs,
secondary to flexural rigidity and other implant mechanical features. If a greater prevalence
of ALTR is found in components with more flexible connections, this could drive the practice
of THA to stiffer connections.
In this study, we will evaluate two important causes of implant failure: (1) in designs not
traditionally associated with ALTRs such as metal-on-polyethylene (MOP) and
ceramic-on-polyethylene (COP) we will assess patients indicated for revision THA surgery with
MRI and correlate the imaging metrics to targeted biopsy retrieval obtained at the time of
revision (including the trunnion), the extent of tissue damage documented at surgery, and
implant retrieval analysis of the neck trunnion, including flexural rigidity analysis; and
(2) to longitudinally assess implant integration using qualitative MRI evaluation of the
bone-implant interface as well as quantitative MRI techniques, T2 mapping and T2* mapping
using MAVRIC-UTE, to evaluate relaxometry at the interface.
concerns have been raised regarding the development of adverse local tissue reactions
(ALTRs). Our group has previously found that: 1) Magnetic resonance imaging (MRI) can detect
and distinguish wear debris from THA; 2) MRI is sensitive to ALTR damage from different
articulating surfaces; and 3) variable host-mediated response to wear debris mounts distinct
morphologic patterns on MRI. There is continued interest in the evaluation of soft tissues
near THAs as traditional THA designs, including metal-on-polyethylene (MOP) and
ceramic-on-polyethylene (COP) bearing surfaces, have recently been implicated in ALTRs. It is
believed that fretting and corrosion at the head-neck junction is responsible for ALTRs,
secondary to flexural rigidity and other implant mechanical features. If a greater prevalence
of ALTR is found in components with more flexible connections, this could drive the practice
of THA to stiffer connections.
In this study, we will evaluate two important causes of implant failure: (1) in designs not
traditionally associated with ALTRs such as metal-on-polyethylene (MOP) and
ceramic-on-polyethylene (COP) we will assess patients indicated for revision THA surgery with
MRI and correlate the imaging metrics to targeted biopsy retrieval obtained at the time of
revision (including the trunnion), the extent of tissue damage documented at surgery, and
implant retrieval analysis of the neck trunnion, including flexural rigidity analysis; and
(2) to longitudinally assess implant integration using qualitative MRI evaluation of the
bone-implant interface as well as quantitative MRI techniques, T2 mapping and T2* mapping
using MAVRIC-UTE, to evaluate relaxometry at the interface.
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.
We found this trial at
1
site
535 E 70th St
New York, New York 10021
New York, New York 10021
(212) 606-1000
Principal Investigator: Matthew F Koff, PhD
Phone: 212-774-2103
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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