Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases (NCT04415814) | Clinical Trial Compass
UnknownNot Applicable
Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases
Russia40 participantsStarted 2019-01-01
Plain-language summary
Determining the treatment strategy for patients with degenerative diseases of the spine is extremely difficult, without an accurate understanding of the nature of stress distribution in the vertebral-motor segments of the spine, as well as biomechanical changes that are associated with degenerative diseases of the spine. In this clinical study, we want to compare the use of unilateral and bilateral transpedicular fixation for treating the patients with degenerative diseases of the lumbar spine.
Who can participate
Age range
18 Years – 90 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:
* Written informed consent of the patient to participate in the study;
* Patients with degenerative diseases of the lumbar spine.
* The opportunity for observation during the entire study period (12 months);
* Mental adequacy, ability, willingness to cooperate and follow the doctor's recommendations.
Exclusion Criteria:
* The refusal of a patient from surgery
* The presence of contraindications to surgery
* Severe forms of diabetes (glycosylated hemoglobin \>9%);
* Blood diseases (thrombopenia, thrombocytopenia, anemia with Hb\< 90g\\l);
* The unwillingness of the patient to conscious cooperation.
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
fusion rate of the operated spine segment
Timeframe: in 3 months after surgery
2
fusion rate of the operated spine segment
Timeframe: in 6 months after surgery
3
fusion rate of the operated spine segment
Timeframe: in 12 months after surgery
Trial details
NCT IDNCT04415814
SponsorI.M. Sechenov First Moscow State Medical University