Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
lumbar corset · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | brace |
| 2 | PLACEBO_COMPARATOR | no brace |
| Name | Type | Description |
|---|---|---|
| lumbar corset | OTHER | - |
Inclusion Criteria: * Age 18-80 * Undergoing posterior lumbar fusion surgery for degenerative conditions Exclusion Criteria: * Unable to complete questionnaires due to language or cognitive barrier * Declined study participation
The lumbar corset is a medical device used for lumbar fusion, a surgical procedure that joins two or more vertebrae in the lower back. It is intended to support the spine following low back surgery. The device is currently in Phase 3 clinical development and is being studied for this specific indication.
The lumbar corset is developed by Medtronic plc, a medical technology company. Medtronic is publicly traded under the ticker symbol MDT on the New York Stock Exchange. The company is conducting clinical research to evaluate the device's use in patients undergoing lumbar fusion surgery.
The lumbar corset is in Phase 3 clinical development. It is an investigational device and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the device is being evaluated for its safety and effectiveness in supporting patients after low back surgery.
The lumbar corset has one completed clinical trial with the identifier NCT00620399, titled "A Study on the Use of a Brace Following Low Back Surgery." This Phase 3 trial was conducted in the United States and enrolled adult participants of all sexes. The study was placebo-controlled and evaluated the device's use in lumbar fusion patients.
The lumbar corset is not FDA approved. It is an investigational device currently in Phase 3 clinical development. The completed clinical trial, NCT00620399, was a placebo-controlled study conducted in the United States. Regulatory approval has not been granted, and the device remains under investigation.
The lumbar corset is a medical device, not a pharmaceutical, so it does not target a specific molecular pathway. Instead, it provides external support to the lumbar spine. It is designed to stabilize the lower back area following lumbar fusion surgery, potentially aiding in the healing process.