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NCT02255331 · ClinicalTrials.gov registry record
Using MRI To Detect Soft Tissue Reactions And Implant Integration As Related To Implant Modularity
A clinical trial of Complications; Arthroplasty and Complications; Arthroplasty, Mechanical, sponsored by Hospital for Special Surgery, New York.
- Recruiting
- Registry status
- 240
- Enrollment target
- 1
- Study location
NCT02255331: Recruiting study of Complications; Arthroplasty and Complications; Arthroplasty, Mechanical, sponsored by Hospital for Special Surgery, New York.
NCT02255331 is a study of Complications; Arthroplasty and Complications; Arthroplasty, Mechanical that is actively recruiting participants, run by Hospital for Special Surgery, New York. The registered enrollment target is 240 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02255331, a study of Complications; Arthroplasty and Complications; Arthroplasty, Mechanical, is actively recruiting participants, sponsored by Hospital for Special Surgery, New York.
- RECRUITING
- Registry status
- 240 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 comp
Conditions Studied
Study Locations (1)
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2017-09-15 |
| Est. Completion | 2026-08 |
What NCT02255331 shows while recruiting
NCT02255331 is an observational study that tracks outcomes without assigning an intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap.
The record links to 2 conditions, with Complications; Arthroplasty appearing as the primary indexed condition, and to 0 interventions.
NCT02255331 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02255331 about?
NCT02255331 is a clinical study titled "Using MRI To Detect Soft Tissue Reactions And Implant Integration As Related To 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 w...
What is the current status of trial NCT02255331?
This trial is currently recruiting. The enrollment target is 240 participants. The study started on 2017-09-15. Estimated completion is 2026-08.
What conditions does trial NCT02255331 study?
This clinical trial studies the following conditions: Complications; Arthroplasty, Complications; Arthroplasty, Mechanical.
Who is sponsoring clinical trial NCT02255331?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02255331 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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