Spinal Stenosis Clinical Trial
Official title:
Prospective Multicenter Clinical Evaluation of Fusion
Verified date | June 2014 |
Source | Baxano Surgical, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Western Institutional Review Board |
Study type | Observational |
The purpose of this study is to demonstrate the relative efficacy of two lumbar fusion
procedures: transacral lumbar interbody fusion when used in conjunction with unilateral or
bilateral posterior pedicle screw fixation as an adjunct to fusion, in comparison to
transforaminal lumbar interbody fusion (TLIF) when used in conjunction with unilateral or
bilateral supplemental screw fixation as an adjunct to fusion.
Subject candidates are those who had previously required and received fusion at L4-L5-S1
where these were the only lumbar levels treated for pseudoarthrosis, spinal stenosis,
spondylolisthesis, or degenerative disc disease (DDD).
Status | Completed |
Enrollment | 60 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult 18 years of age or older - Male or female subject that had previously received the transsacral two-level procedure when used in conjunction with pedicle screw or facet screw fixation or TLIF two-level procedure with unilateral or bilateral supplemental screw fixation (e.g. pedicle screws, facet screws at L4-L5-S1 to treat pseudoarthrosis, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD) - Subject that was treated no less than 2 years prior to this evaluation with an transsacral or TLIF procedure by the participating surgeons - Subject that had a diagnosis that required a transsacral or TLIF procedure at the L4-L5-S1 levels and did not require treatment at any other lumbar levels at the time of surgery Exclusion Criteria: - Subject who did not receive the transsacral or TLIF procedure for fusion of L4-L5-S1 - Subject who received lumbar fusion procedures at levels other than L4-L5-S1 at the time of surgery |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United States | Bone and Joint Clinic of Baton Rouge | Baton Rouge | Louisiana |
United States | Brazos Spine | College Station | Texas |
United States | Indiana Spine Group | Indianapolis | Indiana |
United States | Foundation for Orthopaedic Research and Education | Tampa | Florida |
United States | Michigan Spine Institute | Waterford | Michigan |
Lead Sponsor | Collaborator |
---|---|
Baxano Surgical, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Additional Secondary Endpoint: Efficacy | Comparative Lordosis of L4-S1 at 24-months as determined by an independent orthopedic surgeon reviewer's interpretation of 24-month lateral (neutral) radiographs compared to baseline. | Assessed at 2 years post-op | No |
Primary | Efficacy | Fusion of the targeted vertebral bodies (L4-L5-S1) at 24 months as determined by independent orthopedic surgeon reviewer interpretation of high resolution Computed Tomography (CT) scan. | Assessed at 2 years post-op or greater | No |
Secondary | Safety | Incidence of major device-related adverse events and/or failures, defined as those requiring revision surgery or a secondary operation, or events resulting in permanent disability or death. | 2 years post-op | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06290908 -
RPE-P/TLIF for Lumbar Spinal Stenosis With Instability
|
||
Withdrawn |
NCT03223701 -
Efficacy of Using Solum IV and BMC With GFC in TLIF
|
Phase 4 | |
Recruiting |
NCT03883022 -
Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
|
N/A | |
Completed |
NCT02902380 -
The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery
|
N/A | |
Not yet recruiting |
NCT06024785 -
Vertebropexy - Randomized-controlled Trial
|
N/A | |
Not yet recruiting |
NCT06000319 -
Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
|
||
Completed |
NCT02558621 -
New Robotic Assistance System for Spinal Fusion Surgery
|
N/A | |
Completed |
NCT02454400 -
Pre-surgery Physiotherapy for Patients With Specific Low Back Pain
|
N/A | |
Completed |
NCT01377623 -
Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion
|
N/A | |
Completed |
NCT00996073 -
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion
|
Phase 2 | |
Terminated |
NCT00974623 -
Bone Graft Materials Observational Registry
|
N/A | |
Completed |
NCT00022776 -
Surgical Versus Nonsurgical Treatment for Spinal Stenosis
|
Phase 3 | |
Completed |
NCT00320619 -
Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery
|
N/A | |
Completed |
NCT06060821 -
Validity and Reliability of the 2-minute Step Test in Patients With Lumbar Spinal Stenosis
|
||
Recruiting |
NCT04552145 -
Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis
|
N/A | |
Active, not recruiting |
NCT04379921 -
Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch
|
N/A | |
Withdrawn |
NCT04315090 -
Post-surgical Outcomes Measure Using the ERAS Protocol for Posterior Cervical Decompression and Fusion
|
||
Completed |
NCT04591249 -
Physical Activity Intervention for Patients Following Lumbar Spine Surgery
|
N/A | |
Recruiting |
NCT04601363 -
Personalized Spine Study Group (PSSG) Registry
|
||
Completed |
NCT04193488 -
Mid-Transverse Process to Pleural (MTP) Block and Erector Spinal Plan (ESP) Block in Spinal Surgery
|
N/A |