Clinical trials: Spine Fusion
Spondylosis, Cervical Spondylosis
ViBone in Cervical and Lumbar Spine Fusion
Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.
- Conditions
- Spondylosis, Cervical Spondylosis, Spondylolisthesis, Herniated Nucleus Pulposus
- Trial name
- NCT03425682
- Testing
- ViBone
- Where
- 4 sites in United States
- Volunteers
- 118 people
- Sponsor
- Elutia Inc.
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.
Spine Fusion
InductOs® in Real World Spine Surgery; A Retrospective, French, Multi-centric, Study
It is a phase IV, national, multicenter, observational, retrospective study collecting data from patient medical files in French spinal centers.
- Trial name
- InductOR (NCT02280187)
- Testing
- Spine Fusion
- Where
- 10 sites in France
- Volunteers
- 400 people
- Sponsor
- Medtronic Spinal and Biologics
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.
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
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
Postoperative Pain Management
Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries
Primary Objective: The primary objective of this study is to compare postsurgical opioid consumption through 72 hours postsurgery in patients receiving local infiltration analgesia (LIA) with EXPAREL and bupivacaine HCl (EXPAREL…
- Trial name
- FUSION (NCT03927911)
- Testing
- EXPAREL and Bupivacaine, Standard of Care
- Where
- 12 sites in United States
- Volunteers
- 65 people
- Sponsor
- Pacira Pharmaceuticals, 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.
Fusion of Spine (Disease), Fractures, Ununited
A Clinical Registry to Collect Patient Outcome Date for the BIOMET® Stimulator Systems
The purpose of this clinical registry is to capture data on an ongoing basis from a population of patients who will use Biomet's BHS, OrthoPak and SpinalPak devices.
- Trial name
- NCT01750840
- Testing
- Biomet® EBI Bone Healing System, Biomet Orthopak® Non-Invasive Bone Growth Stimulator System, Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Zimmer Biomet
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
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
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
Symptomatic Cervical Disc Disease
Safety and Efficacy Study Comparing ProDisc-C to ACDF Surgery to Treat SCDD
The objective of this clinical investigation is to compare the safety and effectiveness of ProDisc-C to anterior cervical discectomy and fusion (ACDF) surgery in the treatment of symptomatic cervical disc disease (SCDD).
- Trial name
- NCT00291018
- Testing
- Total Disc Replacement, ACDF
- Volunteers
- 368 people
- Sponsor
- Synthes USA HQ, 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
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.
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
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 Lumbar Spine Causing Back and/or Leg Pain, Lumbar Spine Degeneration
A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine
The aim of the study is to observe and document surgical practice and evaluate patients' outcomes following a MAST™ single or double level instrumented fusion procedure using PLIF (Posterior Lumbar Interbody Fusion) or TLIF…
- Trial name
- MASTERS-D (NCT01143324)
- Testing
- MAST™ procedure
- Where
- 19 sites in Austria, Belgium and 12 more
- Volunteers
- 255 people
- Sponsor
- Medtronic Spinal and Biologics
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
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