- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02255331
Using MRI To Detect Soft Tissue Reactions And Implant Integration As Related To Implant Modularity
The Ability Of MRI To Detect Adverse Local Tissue Reaction And Implant Integration As A Function Of Hip Implant Modularity
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Matthew F Koff, PhD
- Phone Number: 212-774-2103
- Email: koffm@hss.edu
Study Contact Backup
- Name: Mauro Miranda, MFA
- Phone Number: 212-774-1979
- Email: mirandam@hss.edu
Study Locations
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New York
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New York, New York, United States, 10021
- Recruiting
- Hospital for Special Surgery
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Contact:
- Mauro Miranda, MFA
- Phone Number: 212-774-1979
- Email: mirandam@hss.edu
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Contact:
- Matthew Koff, PhD
- Phone Number: 212-774-2103
- Email: koffm@hss.edu
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Principal Investigator:
- Matthew F Koff, PhD
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Principal Investigator:
- Hollis G Potter, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
Exclusion Criteria:
Cohort #1:
- Have occupational exposure to cobalt or chromium
- Presence of MOM or recalled implant
- Have had a prior revision of your total hip
- Standard contra-indications to MRI
Cohort #2:
- Have occupational exposure to cobalt or chromium.
- Have cemented components.
- Presence of a metal-on-metal or recalled implant.
- Standard contra-indications to MRI.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Retrieval Analysis
You qualify for this Retrieval Analysis study if you:
You do not qualify for this arm of the study if you:
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Longitudinal Evaluation
You qualify for this arm of the study if you:
You do not qualify for this arm of the study if you:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Utilize MRI to evaluate total hip arthroplasty designs traditionally not implicated with the presence of adverse local tissue reactions.
Time Frame: An expected average of 1 year post-operatively
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All enrolled arthroplasty designs will be evaluated utilizing the input of:
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An expected average of 1 year post-operatively
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Longitudinal monitor of arthroplasty loosening in patients with different individual risk factors and implant bearing surfaces and characteristics
Time Frame: This outcome will be measured at 4 different time points: Initial office visit, 1 year follow-up, 2 year follow-up, 3 year follow-up.
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All enrolled arthroplasty designs will be evaluated utilizing the input of:
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This outcome will be measured at 4 different time points: Initial office visit, 1 year follow-up, 2 year follow-up, 3 year follow-up.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mode of total hip arthroplasty failure
Time Frame: An expected average of 1 year post-operatively
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Patients will be classified as symptomatic with mechanical symptoms and symptomatic with unexplained pain.
These groups are based on the categories used by the National Joint Registry of England and Wales.
Patients presenting with loosening, instability, or malalignment will be classified as "mechanical" failure.
In cases of loosening, patients will be categorized as having acetabular or femoral loosening, only when documented intra-operatively by the surgeon.
Patients presenting with pain not attributable to implant loosening, instability, or component malposition will be classified as "unexplained" failure.
No specific unit of measure will be used for this outcome measure.
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An expected average of 1 year post-operatively
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Blood serum metal ion levels
Time Frame: Measurement at an expected average of 1 year post operatively for revision total hip arthroplasty patients, or at initial office visit, 1 year follow-up, 2 year follow-up, and 3 year follow-up for individuals being monitored longitudinally.
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Blood samples will be drawn into lithium-heparin containing tubes with non-contamination precautions, and analyzed with high resolution inductively coupled mass spectrometry for the most accurate assessment of Cobalt and Chromium metal ion levels, to be measured in parts per million (ppm) or microgram per liter (ug/L)
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Measurement at an expected average of 1 year post operatively for revision total hip arthroplasty patients, or at initial office visit, 1 year follow-up, 2 year follow-up, and 3 year follow-up for individuals being monitored longitudinally.
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Radiographic evaluation of implant orientation - anteversion and inclination
Time Frame: Measurement at an expected average of 1 year post operatively for revision total hip arthroplasty patients, or at initial office visit for individuals being monitored longitudinally.
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The assessment of hip replacement acetabular component position will be performed using the Einzel-Bild-Roentgen-Analysis (EBRA) software.
The femoral stem-shaft angle will be measured in the frontal plane.
The acetabular inclination angle will be measured in the frontal plane.
The acetabular anteversion angle will be measured in the lateral plane.
All measurements will be expressed in units of degrees.
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Measurement at an expected average of 1 year post operatively for revision total hip arthroplasty patients, or at initial office visit for individuals being monitored longitudinally.
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MRI evaluation of soft tissues surrounding total hip arthroplasty
Time Frame: Measurement at an expected average of 1 year post operatively for revision total hip arthroplasty patients, or at initial office visit, 1 year follow-up, 2 year follow-up, and 3 year follow-up for individuals being monitored longitudinally.
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Evaluation of MR images: Presence, location, type and volume (measurement units of mm^3) of synovitis, Synovial thickness (measurement units of mm), Impression of synovium, Decompression of synovitis, Decompression into Trochanteric Bursa, Decompression into Iliopsoas, Presence and location of low signal intensity deposits, Presence of soft tissue edema, Presence and location of dehiscence, Presence, location and volume (measurement units of mm^3) of osteolysis, Assessment of implant loosening, Presence of and location of neurovascular compression, Disruption of abductors due to distended pseudocapsule, Presence of enlarged lymph nodes and presence and grading of adverse local tissue reaction.
All quantitative values have the units of measurement indicated.
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Measurement at an expected average of 1 year post operatively for revision total hip arthroplasty patients, or at initial office visit, 1 year follow-up, 2 year follow-up, and 3 year follow-up for individuals being monitored longitudinally.
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Intraoperative damage assessment
Time Frame: Measurement during revision surgery for total hip arthroplasty patients
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A subjective scoring system will be used for intraoperative damage assessment of the hip joint.
The system is based on a 0 to 3 scale denoting the level of involvement of the soft tissues surrounding the joint (capsule, synovium, and muscle): 0 = Normal tissue; 1 = Fluid collection ± mild synovial reaction with or capsular dehiscence; 2 = the same findings as a score of 1, but with moderate synovial reaction; and 3 = the same findings as a score of 2, but with the addition of damage to the abductor muscle and/or osteolysis.
No specific unit of measure will be used for this outcome measure.
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Measurement during revision surgery for total hip arthroplasty patients
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Histologic analysis of retrieved tissues
Time Frame: Measurement at an expected average of 1 year post operatively for revision total hip arthroplasty patients.
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Histological evaluation will be using a 10 point aseptic lymphocytic vasculitis associated lesion (ALVAL) score to assess tissue reaction to a total hip replacement. The ALVAL score is a summation of individual grades assigned to the integrity of the synovial lining, presence and extent of inflammatory cell infiltrates, necrosis and tissue organization. We will use a supplemental grading system intended for metal-on-poly and ceramic implants since ALVAL grading is used primarily for metal-on-metal (MOM) articulations and may not detect similar features of wear debris in non-MOM articulations, polyethylene, metal or corrosion products. The presence of ceramic and polyethylene particles and the relative number of macrophages, giant cells, histiocytes, acute or chronic inflammatory cells, and presence of necrotic tissue will be graded using the scale of: 1) absent (-), little (+), moderate (++), extensive (+++). No specific unit of measure will be used for this outcome measure. |
Measurement at an expected average of 1 year post operatively for revision total hip arthroplasty patients.
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Implant retrieval wear analysis
Time Frame: Measurement at an expected average of 1 year post operatively for revision total hip arthroplasty patients.
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The bearing surfaces of the femoral heads and acetabular components, the neck trunnion of the total hip replacement femoral stems, and the matching female tapers of the total hip replacement heads retrieved at surgery will be scanned with a technique that utilizes a non-contact measurement method to calculate volumetric wear (measurement units of mm^3) and linear wear (measurement units of mm).
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Measurement at an expected average of 1 year post operatively for revision total hip arthroplasty patients.
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T2 Mapping of synovial tissues
Time Frame: Measurement at an expected average of 1 year post operatively for revision total hip arthroplasty patients.
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Quantitative imaging, specifically T2 mapping of soft tissues near the implant, specifically, the synovium and synovial volume.
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Measurement at an expected average of 1 year post operatively for revision total hip arthroplasty patients.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Matthew F Koff, PhD, Hospital for Special Surgery, New York
- Principal Investigator: Hollis G Potter, MD, Hospital for Special Surgery, New York
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2015-442 R01 AR064840
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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