The Ability Of MRI To Detect Adverse Local Tissue Reaction And Implant Integration As A Function Of Hip Implant Modularity
Sponsor study identifier
observational
587
1 country
1
Study Start
September 15, 2017
Actual (reported)Primary Completion
November 1, 2024
Actual (reported)Study Completion
November 1, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 28, 2014
Actual (reported)October 2, 2014
Actual (reported)September 15, 2017
Actual (reported)November 1, 2024
Actual (reported)November 1, 2024
Actual (reported)Utilize MRI to evaluate total hip arthroplasty designs traditionally not implicated with the presence of adverse local tissue reactions.
All enrolled arthroplasty designs will be evaluated utilizing the input of: 1. Evaluation of MR images: Presence, location, type and volume of synovitis, Synovial thickness, Impression of synovium, Presence and location of decompression of synovitis, Presence and location of low signal intensity deposits, Presence of soft tissue edema, Presence and location of dehiscence, Presence, location and volume 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. 2. Pre-operative blood metal ion levels 3. Pre-operative Hip disability and Osteoarthritis Outcome Score 4. Pathologic evaluation of tissue obtained intra-operatively 5. Intra-operative grade of soft tissues around the primary total hip replacement 6. Implant wear analysis
An expected average of 1 year post-operatively
Longitudinal monitor of arthroplasty loosening in patients with different individual risk factors and implant bearing surfaces and characteristics
All enrolled arthroplasty designs will be evaluated utilizing the input of: 1. The formation a fibrous membrane and/or osteolysis around the implants 2. Individual risk factors from subjects (gender, BMI, primary diagnosis, and level of activity) 3. Individual risk factors based on implant characteristics (stem length, head size, and modular stem connections).
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.
Mode of total hip arthroplasty failure
An expected average of 1 year post-operatively
Blood serum metal ion levels
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.
Radiographic evaluation of implant orientation - anteversion and inclination
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.
MRI evaluation of soft tissues surrounding total hip arthroplasty
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.
Intraoperative damage assessment
Measurement during revision surgery for total hip arthroplasty patients
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.)
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.)
Individuals who will be having revision surgery of a total hip replacement, or individuals who currently have a total hip replacement with uncemented components.
Hospital for Special Surgery
New York, New York, 10021, United States
1\. A small sample of soft tissues surrounding a total hip replacement will be retained for histological evaluation
Matthew F Koff, PhD
Hospital for Special Surgery, New York
Hollis G Potter, MD
Hospital for Special Surgery, New York
587 participants (actual enrollment reported by the registry).
First Submitted
August 28, 2014
First Posted
October 2, 2014
Study Start
September 15, 2017
Actual (reported)Correlation of Spinopelvic Parameters and Acetabular Cup Orientation
Contact the study team to confirm eligibility.
Primary Completion
November 1, 2024
Actual (reported)Study Completion
November 1, 2024
Actual (reported)Last Updated
August 19, 2026
Record last verified: 2026-06
We will encourage the sharing of our final research data to enable further exploration of the data not presented in the application and for encouraging other individuals to develop new methods of data analysis. The data will be organized by subject number and by date of procedure (e.g. radiographs, MRI, serum metal ion levels, histology, wear analysis, etc.) for ease of identifying a specific dataset. The data will be stored on our servers and back-up drives. Individuals requesting electronic data will be given a link to a private web server to download the requested information, or will be requested to pay a nominal fee to burn the data to CD or DVD or to download to an individual's blank external hard drive, and for mailing charges depending on the type of data requested. Our goal is to make the data as easily accessible to the public as possible.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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