Clinical trials: Spinal Fusion
Pain, Postoperative
Analgesic Efficacy of Repeated Doses of Intravenous (IV) Acetaminophen in Post-operative Pediatric Spine Fusion Patients
This is a prospective, randomized, double-blinded, placebo controlled trial Potential subjects will be identified from the Pre-Surgical Anesthesia Clinic visit.
- Trial name
- IV APAP SF (NCT01394718)
- Testing
- Intravenous Acetaminophen
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- Children's Hospital of Philadelphia
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 Disc Disease
TXA in Spinal Fusion
Tranexamic acid and placebo will be given during surgery to patients who have elected to undergo lumber interbody fusion on 2 or more levels.
- Trial name
- NCT04272606
- Testing
- Tranexamic Acid, Saline Solution, Visual Acuity Exam
- Where
- United States
- Volunteers
- 123 people
- Sponsor
- Catherine R. Olinger
Lumbar Spinal Stenosis, Spondylolisthesis
Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery
The objective of the clinical investigation is to assess the proportion of lumbar spinal stenosis surgical treatment plans that change when an objective measurement of spinal stability is included and applied following a simple…
- Trial name
- SPSI (NCT03754972)
- Testing
- Sagittal plane shear index (SPSI)
- Where
- 3 sites in Netherlands
- Volunteers
- 100 people
- Sponsor
- Medical Metrics Diagnostics, Inc
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.
Lumbar Spinal Fusions
Pregabalin for the Treatment of Pain After Posterior Spinal Fusions
Acute pain management is challenging in patients after spinal fusions, particularly since most have taken analgesics for prolonged periods before choosing the surgical alternative.
- Trial name
- NCT01366196
- Testing
- Pregabalin 150 mg
- Where
- United States
- Volunteers
- 86 people
- Sponsor
- Hospital for Special Surgery, New York
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 Joint Disease, Congenital Deformity
Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
STUDY OBJECTIVES: To demonstrate equivalent clinical and radiologic outcomes as "gold standard" (Autologous Bone Graft) in a representative clinical model (hindfoot fusions) STUDY HYPOTHESIS: Augment® Injectable is an equivalent…
- Conditions
- Degenerative Joint Disease, Congenital Deformity, Arthritis, Osteoarthritis
- Trial name
- NCT01305356
- Testing
- Augment® Injectable Bone Graft, Autologous bone graft
- Where
- 25 sites in United States, Canada
- Volunteers
- 299 people
- Sponsor
- BioMimetic Therapeutics
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
Intervertebral Disk Degeneration
An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
The aim of this trial is to evaluate if P-15 bone putty (investigational device) is not inferior in effectiveness and safety to local autologous bone (control device) when applied in instrumented anterior cervical discectomy and…
- Trial name
- NCT00310440
- Testing
- P-15 Synthetic osteoconductive bone substitute, Autologous bone
- Where
- 12 sites in United States, Canada
- Volunteers
- 319 people
- Sponsor
- CeraPedics, Inc
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
Juvenile; Scoliosis, Scoliosis Idiopathic
Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery
This is a randomized controlled trial to test effectiveness of the SurgeryPal intervention vs. education control to improve acute and chronic pain and health outcomes in youth undergoing major musculoskeletal surgery.
- Conditions
- Juvenile; Scoliosis, Scoliosis Idiopathic, Scoliosis; Adolescence, Scoliosis;Congenital
- Trial name
- SurgeryPal (NCT04637802)
- Testing
- CBT (SurgeryPal), Education
- Where
- United States
- Volunteers
- 433 people
- Sponsor
- Seattle Children's Hospital
Radiculopathy, Myelopathy
PCM Cervical Disc System
The PCM Cervical Disc was studied in a prospective, multicenter, randomized FDA-approved investigational device exemption (IDE) clinical trial conducted in the United States to evaluate longitudinal outcomes over 2 years…
- Trial name
- NCT00578812
- Testing
- Anterior Cervical Discectomy and Fusion (ACDF), PCM Cervical Disc
- Where
- 23 sites in United States
- Volunteers
- 494 people
- Sponsor
- NuVasive
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.
Spinal Stenosis
Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis
Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis
- Trial name
- NCT00534235
- Testing
- Decompression, Posterolateral Fusion and Implantation of Pedicle Screws, Implantation of coflex Interlaminar Technology
- Volunteers
- 322 people
- Sponsor
- Paradigm Spine
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)
Postoperative Pain
Perioperative Use of Gabapentin To Decrease Narcotic Requirements in Spinal Fusion
Blinded study using oral gabapentin in load pre-operative (15mg/kg) and maintenance 5mg/kg three times a day (TID) for 5 days or discharge, Patient Controlled Analgesia (PCA) morphine and placebo group with similar pills, also…
- Trial name
- NCT00726999
- Testing
- Gabapentin, Morphine
- Volunteers
- 63 people
- Sponsor
- Medical College of Wisconsin
Degenerative Disc Disease
Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating
The purpose of this combined retrospective and prospective clinical study is to examine the clinical outcomes of the ROI-C® anterior cervical interbody fusion device with VerteBRIDGE® plating to treat single level degenerative…
- Trial name
- NCT02104167
- Testing
- ROIC interbody cage with VerteBRIDGE plating
- Where
- 7 sites in United States
- Volunteers
- 110 people
- Sponsor
- LDR Spine USA
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
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