Clinical trials: Spinal Fusion
Spinal Stenosis
Retrospective Evaluation of Performance of Coflex® Interlaminer Technology Versus Decompression With or Without Fusion
To evaluate clinical, radiologic and patient-reported outcomes who have been treated 1 or 2 levels with the coflex® Interlaminar Technology or decompression with or without fusion.
- Trial name
- NCT03041896
- Testing
- coflex® Interlaminar Technology
- Volunteers
- 5,050 people
- Sponsor
- Paradigm Spine
Degenerative Changes, Stenosis
Accell Evo3™ Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for instrumented posterolateral spine fusion, as compared to local autograft.
- Conditions
- Degenerative Changes, Stenosis, Spondylosis
- Trial name
- NCT02018445
- Testing
- Posterolateral Fusion
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- SeaSpine, Inc.
Degenerative Disc Disease
Outcome Study of Patients Treated With Translational Cervical Plate Used to Treat Degenerative Disc Disease
The purpose of this study is to measure the benefits of anterior (from the front) cervical (neck) surgery for degenerative disc disease.
- Trial name
- NCT00443547
- Testing
- Vectra-T
- Where
- 13 sites in United States
- Volunteers
- 231 people
- Sponsor
- Synthes USA HQ, Inc.
Postoperative Pain Management
Phase 4, Controlled Study in Adult Subjects Undergoing Primary, 1-2 Level, Open Lumbar Spinal Fusion Surgery
Primary Objective: The primary objective of this study is to compare postsurgical pain control following local infiltration analgesia (LIA) with EXPAREL admixed with bupivacaine HCl versus LIA with bupivacaine HCl in adult…
- Trial name
- NCT03015961
- Testing
- EXPAREL and bupivacaine HCl, Bupivacaine HCl
- Where
- 15 sites in United States
- Volunteers
- 38 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Spinal Fusion, Cardiopulmonary Bypass
Point of Care Testing in Pediatric Patients Undergoing Major Surgery
The current study proposes to investigate Point of Care Testing (POCT) (Coagcheck®) and compare obtained results versus standard laboratory coagulation parameters prothrombin time (PT) and partial thromboplastin time (PTT).
- Trial name
- NCT01742936
- Testing
- CoaguChek, Hospital Laboratory
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Nationwide Children's Hospital
Symptomatic Cervical Disc Disease
Performance of the Hedrocel(R) Cervical Fusion Device
The objective of this clinical investigation is to compare patients treated with Anterior Cervical Discectomy and Fusion (ACDF) using the Hedrocel Cervical Fusion Device, with a concurrent, randomized, control group receiving…
- Trial name
- NCT00758758
- Testing
- Anterior Cervical Discectomy and Fusion
- Where
- 13 sites in United States
- Volunteers
- 231 people
- Sponsor
- Zimmer Biomet
Lumbar Degenerative Disc Disease
Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery
Adjunct therapy for increasing posterolateral fusion success following single level posterior instrumented lumbar surgery.
- Trial name
- EXO-SPINE (NCT00744861)
- Testing
- Exospine, Exogen 4000+
- Volunteers
- 328 people
- Sponsor
- Bioventus LLC
Lumbar Degenerative Disc Disease
Radiographic Analysis Using PureGen Versus Autologous Bone in Posterolateral Fusion (PLF)
The purpose of this study is to evaluate the rate and quality of fusion of PureGen Osteoprogenitor Cell Allograft, compared to autograft bone in instrumented posterolateral fusion (PLF) procedures.
- Trial name
- NCT01294007
- Testing
- PureGen Osteoprogenitor Cell Allograft, Autograft bone
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Alphatec Spine, Inc.
Opioid Use, Spinal Diseases
Opioid Free vs. Standard Perioperative Pain Regimen for Anterior Cervical Discectomy and Fusion (ACDF) Surgery
Patients undergoing 1-3 level Anterior Cervical Discectomy and Fusion (ACDF) at the levels between C2 and T1 will be enrolled into this randomized prospective study.
- Conditions
- Opioid Use, Spinal Diseases, Surgery--Complications, Surgery
- Trial name
- NCT04990804
- Testing
- Opioid Analgesic, Opioid-Free Postoperative Pain Regimen
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Vanderbilt University Medical Center
Degenerative Disc Disease, Degenerative Scoliosis
A Comparison of Stryker's Tritanium Posterior Lumbar Cage and PEEK Implant
The purpose of this study is to compare outcomes of patients with degenerative disc disease undergo lumbar spinal fusion with Stryker's Tritanium® Posterior Lumbar Cage or the UniLIF PEEK implant.
- Trial name
- NCT03817606
- Testing
- Tritanium Posterior Lumbar Cage, AVS UniLIF PEEK Posterior Lumbar Cage
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Riverside Medical Center
Failed Back Surgery Syndrome, Pain
Spinal Cord Stimulation With Precision® System Versus Reoperation for Failed Back Surgery Syndrome
The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as a treatment of pain in patients with Failed…
- Conditions
- Failed Back Surgery Syndrome, Pain, Back Pain
- Trial name
- Evidence (NCT01036529)
- Testing
- Precision Spinal Cord Stimulator, Back Surgery
- Where
- 18 sites in United States, Canada and 2 more
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
Cervical Spondylosis With Myelopathy
Cervical Spondylotic Myelopathy Surgical Trial
The purpose of the study is to determine the optimal surgical approach (ventral vs dorsal) for patients with multi-level cervical spondylotic myelopathy (CSM).
- Trial name
- NCT02076113
- Testing
- Ventral (Front) decompression with Fusion, Dorsal (Back) Decompression with Fusion, Dorsal (back) Laminoplasty
- Where
- 16 sites in United States, Canada
- Volunteers
- 269 people
- Sponsor
- Lahey Clinic
Lumbar Spine Degeneration
INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine
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…
- Trial name
- TLIF (NCT01415908)
- Testing
- INFUSE Bone Graft, Iliac Crest Bone Graft
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Disc Disease
Safety and Efficacy Study of Healos as a Bone Replacement to Treat Degenerative Disc Disease
The purpose of this study is to determine the safety and effectiveness of HEALOS compared with autograft using the transforaminal lumbar interbody fusion (TLIF) method.
- Trial name
- NCT00316121
- Testing
- HEALOS and Leopard Cage, Leopard Cage and Autograft
- Where
- 17 sites in United States
- Volunteers
- 138 people
- Sponsor
- Advanced Technologies and Regenerative Medicine, LLC (ATRM)
Scoliosis
Posterior Spinal Fusion With Two Energy Dissection Techniques
The OSTEOVUE™ Spine Dissector is a new ultrasonic energy device, specifically designed for soft tissue removal from vertebral surfaces.
- Trial name
- NCT02465099
- Testing
- Ultrasonic Dissection (UD), Electrocautery Dissection (ED)
- Where
- 5 sites in United States
- Volunteers
- 64 people
- Sponsor
- Ethicon Endo-Surgery
Intervertebral Disk Degeneration, Intervertebral Disk Displacement
Evaluation of Fusion Rate of Anterior Cervical Discectomy and Fusion (ACDF) Using Cervios ChronOs™ and Bonion™
Anterior cervical discectomy and fusion (ACDF) has shown good treatment results for a variety of cervical spine diseases such as herniated intervertebral disc (HIVD), cervical spondylotic radiculopathy (CSR) and cervical…
- Conditions
- Intervertebral Disk Degeneration, Intervertebral Disk Displacement, Ossification of Posterior Longitudinal Ligament
- Trial name
- NCT01615328
- Testing
- Cervios ChronOs, Bonion
- Where
- South Korea
- Volunteers
- 85 people
- Sponsor
- Seoul National University Hospital