Clinical trials: Degeneration Spine
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
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 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.
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
Back Pain, Radiculopathy Lumbar
Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy
SNRB, as measured by the change in pain and objective functional ability, can solicit crucial information regarding a patient's clinical picture and can predict a patient's outcome post-surgery.
- Conditions
- Back Pain, Radiculopathy Lumbar, Degenerative Lumbar Spinal Stenosis
- Trial name
- NCT03801356
- Testing
- Selective Nerve Root Block
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- The Cleveland Clinic
Stenosis, Spondylosis
Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral 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 posterolateral spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01430299
- Testing
- Demineralized Bone Matrix, rh-BMP2
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- SeaSpine, Inc.
Low Back Pain, Lumbosacral Radiculopathy
A Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief
The purpose of this study is to collect information about how patients feel when doctors manage their pain after lumbar spine surgery using a combination of EXPAREL® and bupivacaine injected into the lumbar spine at the end of…
- Conditions
- Low Back Pain, Lumbosacral Radiculopathy, Lumbar Disc Degeneration, Lumbar Disc Herniation
- Trial name
- NCT03514277
- Testing
- Exparel, Bupivacaine
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Virtua Health, Inc.
Stenosis, Spondylosis
Efficacy and Safety of Integra Accell Evo3 DBM 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 lumbar spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01714804
- Testing
- Accell Evo3 Prospective Use
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- SeaSpine, Inc.
Degenerative Disc Disease
Retrospective/Prospective Data Collection on the LDR ROIA Interbody Fusion Device With VerteBRIDGE Plating
The purpose of this combination retrospective and prospective post market study is to examine the short term safety and efficacy of the ROI-A® interbody fusion device with VerteBRIDGE® plates to treat single and two-level…
- Trial name
- NCT02104141
- Testing
- ROIA Interbody Cage with VerteBRIDGE plating
- Volunteers
- 51 people
- Sponsor
- LDR Spine USA
Lumbar Degenerative Disc Disease, Lumbar Spinal Stenosis
Lumbar Fusion With Nexxt Spine 3D-Printed Titanium Interbody Cages
The purpose of this randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo combined interbody/posterolateral lumbar fusion procedures, supplemented with pedicle…
- Conditions
- Lumbar Degenerative Disc Disease, Lumbar Spinal Stenosis, Lumbar Spondylolisthesis, Lumbar Spinal Deformity
- Trial name
- NCT03647501
- Testing
- Interbody cage (titanium), Interbody cage (PEEK)
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Ohio State University
Cervical Disc Herniation, Cervical Degenerative Disc Disease
Effect of Topical Corticosteroids on Dysphagia in Anterior Cervical Discectomy and Fusion
The purpose of this study is to determine what effect intraoperative topical steroids have on reducing swallowing difficulty following Anterior Cervical Discectomy and Fusion surgery.
- Conditions
- Cervical Disc Herniation, Cervical Degenerative Disc Disease, Cervical Spondylotic Myelopathy, Dysphagia
- Trial name
- NCT02539394
- Testing
- Methylprednisolone Acetate, Hemostatic Matrix Kit
- Volunteers
- 128 people
- Sponsor
- Hospital for Special Surgery, New York
Degenerative Disc Disease, Grade 1 Spondylolisthesis
Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine
An evaluation of the incidence of complications resulting from far lateral spine surgery utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody Spacer System versus literature reported results…
- Trial name
- RAVINE (NCT02068729)
- Volunteers
- 131 people
- Sponsor
- K2M, Inc.
Degenerative Disc Disease
LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE
The purpose of this investigation is to establish the safety and effectiveness of the LDR Spine Mobi-C® Cervical Disc Prosthesis which is an anterior cervical interbody mechanical device.
- Trial name
- NCT00389597
- Testing
- Cervical Artificial Disc
- Where
- 24 sites in United States
- Volunteers
- 599 people
- Sponsor
- LDR Spine USA
Spine Disease, Spine Degeneration
Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch
One of the primary goals of spine surgery is to reduce pain and increase mobility to improve patients' quality of life. Currently, there is no established method for surgeons to objectively track their patients' mobilization…
- Conditions
- Spine Disease, Spine Degeneration, Spinal Stenosis, Surgery
- Trial name
- NCT04379921
- Testing
- Apple Watch and App
- Where
- United States
- Volunteers
- 255 people
- Sponsor
- Stanford University
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 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
Lumbar Spine Degeneration
A Randomized Trial of Exparel vs Saline in Opioid Reduction of Pain Management Following Lumbar Spine Surgeries.
The purpose of this study is to establish a relationship between liposomal bupivacaine surgical site injection and postop opioid utilization.
- Trial name
- Exparel (NCT04644796)
- Testing
- saline 0.9%, Liposomal bupivacaine
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- University of Missouri-Columbia
Intervertebral Disc Degeneration
5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures to Treat Degenerative Lumbar Spine (MASTERS-D2)
The purpose of this study is to evaluate the effectiveness of MAST techniques for anterior/lateral and posterior approaches in Degenerative Disc Disease (DDD) patients with spondylolisthesis (≥ grade I).
- Trial name
- MASTERS-D2 (NCT02617563)
- Testing
- Minimally invasive lumbar fusion
- Where
- 27 sites in Argentina, Austria and 15 more
- Volunteers
- 361 people
- Sponsor
- Medtronic Spinal and Biologics
Thoracolumbar Disc Degeneration, Thoracolumbar Spondylolisthesis
The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems (PASS DEGEN)
The purpose of this post-market clinical study is to evaluate the long-term safety and efficacy of the MEDICREA's systems PASS LP, PASS DEGEN, and PASS Tulip PRIME to treat degenerative diseases.
- Conditions
- Thoracolumbar Disc Degeneration, Thoracolumbar Spondylolisthesis, Spinal Deformity, Spinal Degeneration
- Trial name
- PASS DEGEN (NCT04670536)
- Testing
- PASS LP implants, PASS DEGEN, PASS TULIP PRIME
- Where
- 4 sites in France
- Volunteers
- 77 people
- Sponsor
- Medicrea International
Intervertebral Disc Degeneration
Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery
Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation with fentanyl demand controlled by the patient.
- Trial name
- Duloxetine (NCT02535000)
- Testing
- Duloxetine
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Serviço de Anestesiologia de Joinville