Lumbar Spine Degeneration Clinical Trial
Official title:
A Prospective, Multi-center, Pivotal Trial for INFUSE® Bone Graft With CAPSTONE® Spinal System and Posterior Supplemental Fixation to Treat 1- or 2-level Advanced Degenerative Disease of the Lumbosacral Spine For a TLIF Approach
This investigation will provide safety and effectiveness information on the use of INFUSE® Bone Graft with the CAPSTONE® Spinal System and CD HORIZON® Spinal System with a Transforaminal Lumbar Interbody Fusion (TLIF) surgical approach at one or two adjacent levels from L2-S1 to treat subjects with advanced degenerative disease of the lumbosacral spine.
The study is a prospective, multi-national study that compares INFUSE® Bone Graft (investigational group) to autogenous bone graft (control group). Control group subjects will receive the same surgical treatment except for the use of autogenous bone graft (from the iliac crest) instead of INFUSE® Bone Graft. All sites will follow a common Clinical Investigational Plan (CIP) that consists of the protocol and accompanying case report forms, risk analysis, investigator's agreement, subject informed consent, institutional review board (IRB) certification, labeling, and monitoring information. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| 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
|
||
| Terminated |
NCT03527966 -
rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures
|
Phase 4 | |
| Withdrawn |
NCT05408923 -
Randomized Controlled Trial Comparing Irrisept Versus Normal Saline for Wound Irrigation After Posterior Spine Surgery
|
Phase 4 | |
| 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 |