Clinical trials: Spinal Fusion
Degenerative Disc Disease
Study of an Expandable Interbody Device for the Lumbar Spine
The primary objective of this study is to evaluate the safety and efficacy of CALIBER expandable spacer for the treatment of degenerative disc disease.
- Trial name
- CALIBER (NCT02075554)
- Testing
- CALIBER
- Where
- 2 sites in United States
- Volunteers
- 58 people
- Sponsor
- Globus Medical Inc
Spinal Fusion
A Comparison of Ketamine Infusion Versus Placebo in Opioid Tolerant and Opioid Naive Patients After Spinal Fusion
The aim of the proposed study is to examine the effectiveness of low dose postoperative ketamine infusion as an analgesic adjuvant to morphine pca in opioid tolerant and opioid naïve patients after major spine surgery.
- Trial name
- NCT03274453
- Testing
- Ketamine, Saline
- Where
- United States
- Volunteers
- 129 people
- Sponsor
- NYU Langone Health
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.
Prolapsed Lumbar Disc, Prolapsed Cervical Disc
Patient Registry to Observe Outcomes Following Implantation of the VariLift Interbody Fusion Device
The registry has been designed as a prospective, observational program for patients undergoing lumbar or cervical fusion using VariLift device with the ultimate goal to aid in the development of strategic treatment pathways and…
- Conditions
- Prolapsed Lumbar Disc, Prolapsed Cervical Disc, Intervertebral Disc Degeneration, Spondylolisthesis, Grade 1
- Trial name
- NCT01944345
- Where
- 3 sites in United States
- Volunteers
- 69 people
- Sponsor
- Wenzel Spine
Degenerative Changes, Stenosis
OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra's OsteoStrux Collagen Ceramic Scaffold combined with bone marrow aspirate as an adjunct for instrumented posterolateral spine fusion, as compared…
- Conditions
- Degenerative Changes, Stenosis, Spondylosis
- Trial name
- NCT01873586
- Testing
- Posterolateral Fusion
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- SeaSpine, 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
Degenerative Disc Disease, Trauma (Including Fractures)
BIO4 Clinical Case Study: Cervical Spine
The goal of this study is to investigate the efficacy of BIO4 bone matrix in patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery.
- Conditions
- Degenerative Disc Disease, Trauma (Including Fractures), Spondylolisthesis
- Trial name
- NCT03077204
- Testing
- 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window)., Aviator Anterior Cervical Plating System
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Seton Healthcare Family
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)
Spinal Fusion
Efficacy and Safety of Tranexamic Acid in Spinal Fusion Surgery
The purpose of this study is to see if Tranexamic Acid can safely reduce bleeding in people undergoing spinal fusion surgery.
- Trial name
- NCT03425799
- Testing
- Sodium Chloride 0.9% Inj, Tranexamic Acid
- Where
- 4 sites in United States
- Volunteers
- 5 people
- Sponsor
- Exela Pharma Sciences, LLC.
Pain
Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery
Postoperative analgesia following spine surgery is difficult to manage. Current treatment modalities rely heavily on opioid analgesics with all of the inherent limitations and side effects.
- Trial name
- NCT03115151
- Testing
- Bupivacaine, Hydromorphone, Fentanyl
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- University of Texas Southwestern Medical Center
Adolescent Idiopathic Scoliosis, Multimodal Analgesia
Propofol + Remifentanil vs. Propofol + Dexmedetomidine in Adolescent Idiopathic Scoliosis Patients Having Spine Surgery
Patients with Adolescent Idiopathic Scoliosis may need surgery to correct their scoliosis. General anesthesia is required for this surgery, and a multimodal analgesic regimen using combinations of opioid and non-opioid…
- Conditions
- Adolescent Idiopathic Scoliosis, Multimodal Analgesia, Opioid Induced Hyperalgesia, Remifentanil
- Trial name
- NCT06096181
- Testing
- Remifentanil TIVA, Dexmedetomidine TIVA, Propofol TIVA
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Cedars-Sinai Medical Center
Spinal Fusion
The Effects of Dexmedetomidine Dose on Motor Evoked Potentials
This a parallel group, two-arm, randomized superiority trial that will compare the effect of two different doses of dexmedetomidine on motor evoked potentials during spine surgery
- Trial name
- NCT03378973
- Testing
- Dexmedetomidine
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Hospital for Special Surgery, New York
Degenerative Disc Disease
Retrospective Multicenter Clinical Evaluation of Complications for Single or Multilevel VEO® Lateral Access and Interbody Fusion System and eXtreme Lateral Interbody Fusion (XLIF®) Subjects
The purpose of this retrospective clinical evaluation is to compare VEO® single or multilevel results to XLIF® single or multilevel results relative to the safety endpoints.
- Trial name
- NCT01878149
- Where
- 4 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Baxano Surgical, Inc.
Cervical Degenerative Disc Disease
Study to Investigate the Performance of Cervical Arthroplasty for the Treatment of Cervical Degenerative Disc Disease
The purpose of the study is to evaluate the performance of the Discover cervical Artificial disc in the treatment of degenerative disc disease in one level of the cervical spine.
- Trial name
- NCT00700739
- Testing
- DISCOVER™ Artificial Cervical Disc, ACDF
- Where
- 8 sites in Australia, Germany and 5 more
- Volunteers
- 60 people
- Sponsor
- DePuy International
Lumbar Spondylosis, Lumbar Spondylolisthesis
Use of Forteo (Teriparatide) in Posterolateral Lumbar Spine Fusion
The purpose of this study is to determine the effects of 12 weeks of daily treatment with teriparatide on spine fusion in adult patients who are undergoing multi-level posterolateral spine fusion surgery for degenerative…
- Conditions
- Lumbar Spondylosis, Lumbar Spondylolisthesis, Adult Degenerative Lumbar Scoliosis
- Trial name
- NCT01292252
- Testing
- teriparatide
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Shane Burch
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 Disc Disease
Multicenter Study of the Avenue L Interbody Spinal Fusion System Using VerteBRIDGE Plating and Posterior Fixation
The purpose of this prospective clinical study is to examine the short-term safety and efficacy of the Avenue®- L interbody Spinal Fusion System with VerteBRIDGE® plating to treat one and two level degenerative disc disease…
- Trial name
- NCT02068768
- Testing
- Avenue® L Interbody Fusion System (LDR Spine)
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- LDR Spine USA
Ileus, Spinal Fusion
Alvimopan and Ileus in PSF
The purpose of the study is to determine with Alvimopan reduces the incidence of post operative ileus in patients who undergo posterior spinal fusion.
- Trial name
- NCT02218190
- Testing
- Alvimopan
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Washington University School of Medicine
Degenerative Disc Disease, Spinal Stenosis
Clinical Outcomes of the Trinica(R) Anterior Lumbar Plate: Fixed Screws vs. Variable Screws
Trinica Anterior Lumbar Plate (ALP) System is a commercially available, supplemental fusion device for use in the lumbar or sacral spine (L1-S1) to treat instability.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT00762723
- Testing
- Trinica Anterior Lumbar Plate System
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Zimmer Biomet
Curvature of Spine
The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery
The purpose of this study is to determine if tranexamic acid reduces perioperative blood loss and red blood cell transfusion during high risk spine surgery.
- Trial name
- TXA (NCT01728636)
- Testing
- Tranexamic Acid
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Northwestern University