Lumbar Spine Degeneration Clinical Trial
Official title:
rhBMP-2 Versus Vivigen, a Novel Cellular Allograft, in Lumbar Fusion Procedures: a Prospective Randomized Controlled Study
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.
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
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04140344 -
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
|
N/A | |
| Completed |
NCT04914728 -
Mini-invasive Lumbar Arthrodesis in Ambulatory
|
N/A | |
| Recruiting |
NCT05527145 -
Spinal Stenosis and Listhesis Treated With Percutaneous Interspinous Spacer: a Non-surgical Trial
|
N/A | |
| Completed |
NCT05630404 -
Efficacy of Surgical Injection Lumbar Erector Spinae Plane Block
|
N/A | |
| Recruiting |
NCT05452694 -
OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults
|
||
| Recruiting |
NCT04823858 -
3Spine Lumbar Fusion Real World Evidence Study
|
||
| Recruiting |
NCT06154005 -
OsteoAdapt SP Advanced Bone Graft Feasibility Study - Transforaminal Interbody Lumbar Fusion
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04781517 -
Development of a Patient-reported Outcome Instrument for Patients With Lumbar Degenerative Disease After Lumbar Fusion
|
||
| Completed |
NCT03977961 -
The Six-Minute Walking Test (6MWT) as a Measure of Functional Impairment in Lumbar Degenerate Disc Disease.
|
||
| Completed |
NCT03176303 -
Study Using the SpinalStim Device Following Lumbar Fusion Surgery
|
||
| Recruiting |
NCT06462729 -
LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
|
Phase 1/Phase 2 | |
| Completed |
NCT01143324 -
A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine
|
||
| Active, not recruiting |
NCT05438719 -
MOTUS Total Joint Replacement Investigational Device Exemption Study
|
N/A | |
| Not yet recruiting |
NCT05388383 -
Cost-effectiveness Analysis of Robot-assisted Spinal Surgery
|
||
| Completed |
NCT06316921 -
Epidural PCA on Pain Relief After L-spine Surgery
|
||
| Completed |
NCT03452449 -
Physical Activity, Disability and Quality of Life Before and After Lumbar Spine Surgery
|
||
| Withdrawn |
NCT05408923 -
Randomized Controlled Trial Comparing Irrisept Versus Normal Saline for Wound Irrigation After Posterior Spine Surgery
|
Phase 4 | |
| Terminated |
NCT01415908 -
INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine
|
Phase 3 | |
| Completed |
NCT04062942 -
The Six-Minute Walking Test (6WT) and Timed-Up-and-Go (TUG) Test as Measures of Objective Functional Impairment in Patients Undergoing Interlaminar or Transforaminal Epidural Steroid Injection for Lumbar Degenerative Disc Disease (DDD)
|
||
| Completed |
NCT03088306 -
Improving Pain and Reducing Opioid Use (IPaRO) in Lumbar Spine Surgery Patients
|
Early Phase 1 |