BridgeMD
New treatment option for LUMBAR STENOSIS
Official title Spontaneous Correction of Sagittal Imbalance After Isolated Lumbar Decompression
ClinicalTrials.gov ID: NCT07139938
What this study is testing
- What it's testing
- Sagittal spinal imbalance may be caused by orthopedic problems, compression of the neural structures of the spinal canal, and pain syndrome (functional imbalance). Sagittal imbalance in combination with appropriate clinical symptoms may require surgical correction of the spine with fixation.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1\. Age 45 and over;
- 2\. Radicular leg pain and/or neurogenic claudication with/without back pain, caused by single- or multi-level degenerative lumbar stenosis...
- 3\. Planned isolated decompression of the spinal canal without implantation of any devices;
- 4\. Symptoms persisting for at least 3 months prior to surgery;
- 5\. Given written Informed Consent;
You likely can't join if
- 1\. Performed intraoperative discotomy;
- 2\. Performed intraoperative iatrogenic instability of the lumbar segment (facetectomy, foraminotomy, etc.)
See the full eligibility criteria
- 1\. Age 45 and over;
- 2\. Radicular leg pain and/or neurogenic claudication with/without back pain, caused by single- or multi-level degenerative lumbar stenosis with/without spodylolisthesis, confirmed by MRI;
- 3\. Planned isolated decompression of the spinal canal without implantation of any devices;
- 4\. Symptoms persisting for at least 3 months prior to surgery;
- 5\. Given written Informed Consent;
- 6\. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements. Non-
- 1\. Prior any lumbar surgery;
- 2\. Scoliosis of any non-degenerative etiology (due to vertebral fractures, idiopathic, etc.);
- 3\. Degenerative scoliosis \> 20 degrees;
- 4\. Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;
- 5\. Any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study;
- 1\. Performed intraoperative discotomy;
- 2\. Performed intraoperative iatrogenic instability of the lumbar segment (facetectomy, foraminotomy, etc.)
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.