Clinical trials: Degenerative Spine Diseases
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
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
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 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
Cervical Degenerative Disc Disease, Radiculopathy
An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels in the Cervical Spine
This clinical study will assess the metal concentrations present in the blood serum of patients who receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7.
- Conditions
- Cervical Degenerative Disc Disease, Radiculopathy, Myelopathy
- Trial name
- NCT03062657
- Testing
- PRESTIGE LP™ Cervical Disc
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Disc Disease, Intervertebral Disc Disease
Treatment of Degenerative Disc Disease With Allogenic Mesenchymal Stem Cells (MSV)
In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC), obtained from bone marrow of healthy donors, for treatment of Degenerative Disc Disease (DDD).
- Conditions
- Degenerative Disc Disease, Intervertebral Disc Disease, Low Back Pain
- Trial name
- Disc_allo (NCT01860417)
- Testing
- Allogenic Mesenchymal Stromal Cells, Mepivacaine
- Where
- 2 sites in Spain
- Volunteers
- 24 people
- Sponsor
- Red de Terapia Celular
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.
Degenerative Disc Disease, Lumbar, Disc Herniation, Lumbar
Satellite™ PEEK Nucleus Replacement Retrospective Analysis
The Satellite™ Retrospective Analysis is an international, retrospective, multi-center, non-interventional post-marketing study designed to document and analyze existing data with the device in a "real-world" setting.
- Trial name
- NCT01110967
- Where
- 3 sites in Czechia, Slovakia and 1 more
- Volunteers
- 40 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Disc Disease, Spondylolisthesis
The European Robotic Spinal Instrumentation (EUROSPIN) Study
In a multinational prospective study, preoperative, intraoperative, perioperative and follow-up data on patients receiving thoracolumbar pedicle screw placement for degenerative disease or infections or tumors will be collected.
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis, Recurrent Disc Herniation
- Trial name
- EUROSPIN (NCT03398915)
- Testing
- Transpedicular Instrumentation
- Where
- 12 sites in Austria, France and 5 more
- Volunteers
- 932 people
- Sponsor
- Marc Schröder
Degenerative Disc Disease, Spinal Stenosis
Assessment of nanOss Bioactive 3D in the Posterolateral Spine
Spine fusion is one of the most common procedures performed in spinal surgery. Several surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion (PLF) is the most widely used.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT01829997
- Testing
- nanOss Bioactive 3D BVF
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Pioneer Surgical Technology, Inc.
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
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
Degenerative Disc Disease
Maverick Total Disc Replacement in a 'Real World' Patient Population
The primary purpose of the study is to document the reduction of disability after Maverick total disc replacement surgery in a 'real-world' patient population requiring disc replacement.
- Trial name
- Maverick (NCT01338493)
- Testing
- lumbar spinal arthroplasty + Maverick™
- Where
- 13 sites in Canada, France and 1 more
- Volunteers
- 139 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
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
Degenerative Spinal Disease, Deformity of Spine
Fenestrated Screw Study
The primary objective of this post-market study is to demonstrate that Oswestry disability index (ODI) score improved significantly at 12 months post-operatively as compared to baseline for each indication (degenerative spinal…
- Trial name
- FNS (NCT03797144)
- Testing
- CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement
- Where
- 6 sites in Belgium, Finland and 3 more
- Volunteers
- 27 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)
Degenerative Disc Disease
A Multicenter, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of 2 Doses of Intradiscal rhGDF-5 (Single Administration) for the Treatment of Early Stage Lumbar Disc Degeneration
Study to show the safety and tolerability of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration
- Trial name
- NCT01124006
- Testing
- Intradiscal rhGDF-5, Water for injection
- Where
- 10 sites in United States
- Volunteers
- 24 people
- Sponsor
- DePuy Spine
Spondylolisthesis, Stenosis
CopiOs Posterolateral Fusion Procedure
To compare radiographic data collection from patients undergoing instrumented PLF with CopiOs(R) BVF or instrumented PLF with autologous bone and to assess overall clinical outcomes. Patients will serve as self controls.
- Trial name
- NCT01123850
- Testing
- Copios
- Where
- 6 sites in United States
- Volunteers
- 45 people
- Sponsor
- Zimmer Biomet