A Study of Treatment of Painful Spinal Implants using Fluoroscopically Guided Injections
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 13-006423
Sponsor Protocol Number: 13-006423
About this study
The purpose of this study is to: (1) determine if image guided local anesthetic injections directed to dorsal instrumentation can select patients for successful implant removal (2) determine if injection of anesthetics and steroids about painful implants can provide therapeutic benefit that may eliminate the need for implant removal (3) identify other patient characteristics which predict pain relief with implant removal.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Subjects who have undergone image guided injections (2006-2013) and instrumentation hardware suspected of acting as a pain generator in patients who have undergone lumbar fusion procedures.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Timothy Maus, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available