Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-26 @ 8:06 PM
Study NCT ID:
NCT03527966
Status:
TERMINATED
Last Update Posted:
2019-08-28
First Post:
2018-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures
Sponsor:
Virtua Health, Inc.
Organization:
Study Overview
Official Title:
rhBMP-2 Versus Vivigen, a Novel Cellular Allograft, in Lumbar Fusion Procedures: a Prospective Randomized Controlled Study
Status:
TERMINATED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left the institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is aimed at comparing the overall efficacy (clinical and radiographic) of Vivigen, a novel cellular allograft product, and rhBMP-2 when utilized in lumbar fusion procedures.
Detailed Description:
The purpose of this study is to compare the overall efficacy (clinical outcome and radiographic fusion) of Vivigen (cellular allograft product) and rhBMP-2 in patients who undergo a single level lumbar instrumented fusion. Specifically, when compared to their control group counterparts treated to rhBMP-2, we hypothesize that the intervention group administered Vivigen would, following surgery, experience:
1. Comparable mean postoperative leg/back pain score, where the pain scores are obtained using the numeric rating scale of 0-no pain, to 10-worst pain possible
2. Comparable inpatient length of stay (LOS)
3. Comparable postoperative Oswestry Disability Index (ODI) score (0-no disability, to 100-maximum disability possible), two weeks, 6 weeks, 3 months, 6 months, and 1 year postoperatively
4. Comparable fusion rates, evaluated via CT scan I year postoperatively
1. Comparable mean postoperative leg/back pain score, where the pain scores are obtained using the numeric rating scale of 0-no pain, to 10-worst pain possible
2. Comparable inpatient length of stay (LOS)
3. Comparable postoperative Oswestry Disability Index (ODI) score (0-no disability, to 100-maximum disability possible), two weeks, 6 weeks, 3 months, 6 months, and 1 year postoperatively
4. Comparable fusion rates, evaluated via CT scan I year postoperatively
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: