Stopped: Study did not move forward at our institution
United States0Started 2020-06-09
Plain-language summary
To evaluate the efficacy of radiation reduction techniques to minimize clinician and patient exposure during minimally invasive lumbar decompression (MILD) procedure. Additionally, to evaluate the clinical benefits of single incision access for bilateral mild procedure.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 65 years old
* Patient has meets eligibility criteria for (mild)
* Patient has signed study-specific informed consent form
* Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements
* Patient has medical insurance that covers this standard of care procedure and all other anticipated and unanticipated procedure related care.
Exclusion Criteria:
* Patient does not meet criteria for mild
* Patient is unable to receive radiation exposure.
* Current local or systemic infection that raises the risk of surgery
* Patient currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation.
* Currently pregnant
* Known or suspected drug or alcohol abuse
* Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation
* Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation
* Implanted intrathecal pain pump or spinal cord stimulator system in place
* Patient who has received other means pain management with minimally invasive implantable devices (spacer, sacroiliac joint (SIJ) fusion, etc).
* Patient with physical inability to ambulate independently, otherwise.
* Patient underlying neurologic pathology preventing safe independent ambulation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pulsed fluoroscopy can reduce radiation exposure to clinicians and patients compared to continuous fluoroscopy
Timeframe: During surgery
2
Genetic factors can explain individual differences in pain severity and the response to MILD (with and without pulsed fluoroscopy)