Clinical trials: Bone Degenerative Changes
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.
Chronic Low Back Pain, Degenerative Disc Disease
Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms
Opioids are frequently prescribed for chronic low back pain (CLBP). Psychiatric illness, such as high levels of depression and anxiety symptoms, is a common co-occurrence in chronic pain patients (and is termed comorbid negative…
- Conditions
- Chronic Low Back Pain, Degenerative Disc Disease, Depression, Anxiety
- Trial name
- NCT01502644
- Testing
- Oxycodone, Morphine
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- Brigham and Women's Hospital
Spinal Stenosis, Spondylolisthesis
Evaluation of Fusion Rate Using K2M VESUVIUS® Demineralized Fibers With K2M EVEREST® Spinal System
The purpose of this study is to evaluate fusion status and patient outcomes observed from use of the VESUVIUS Demineralized Fibers with the EVEREST Spinal System as compared to the literature reported outcomes of spinal fusion…
- Conditions
- Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease
- Trial name
- NCT02064855
- Volunteers
- 108 people
- Sponsor
- K2M, Inc.
Degenerative Disc Disease, Spondylolisthesis, Grade 1
AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY
This is a post-market clinical study of the AccuLIF expandable transforaminal lumbar interbody fusion (TLIF) cage in patients requiring surgery for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Grade 1, Retrolisthesis
- Trial name
- APROPOS (NCT02704689)
- Testing
- AccuLIF expandable TLIF cage
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- VB Spine, LLC
Non-inflammatory Degenerative Joint Disease, Osteoarthritis
Ceramic-on-Ceramic (COC) 36mm Acetabular Bearing Insert Post Approval Study-New Subjects (COC36mmPAS)
This study is intended to gather short (Pre-operative to 4-years) and mid-term (5-years) information regarding the performance and safety of the commercially available 36mm CERAMAX® Ceramic on Ceramic Total Hip System from a…
- Conditions
- Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis, Post-Traumatic Osteoarthritis of Hip
- Trial name
- COC36mmPAS (NCT02096211)
- Testing
- COC 36mm
- Where
- 13 sites in United States, Canada
- Volunteers
- 172 people
- Sponsor
- DePuy Orthopaedics
Lumbar Spondylolisthesis, Degenerative Disc Disease
Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease
The objective of this study is to perform a prospective, randomized, controlled clinical trial to compare radiographic fusion rates and patient reported outcomes, including pain and function preoperatively and postoperatively…
- Conditions
- Lumbar Spondylolisthesis, Degenerative Disc Disease, Degenerative Spondylolisthesis, Lumbar Radiculopathy
- Trial name
- ViviGen (NCT03733626)
- Testing
- ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system, Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Corewell Health East
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
Degenerative Disc Disease
INFUSE® Bone Graft/ PEEK Interbody Spacer/ Anterior Cervical Plate Pivotal Clinical Trial
The purpose of this study is to evaluate the safety and effectiveness of the investigational implant (INFUSE® Bone Graft/PEEK Interbody Spacer/Anterior Cervical Plate) as a method of facilitating spinal fusion at a single level…
- Trial name
- ACDF (NCT00485173)
- Testing
- INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate
- Where
- 16 sites in United States
- Volunteers
- 224 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.
Lumbar Degenerative Disc Disease
Radiographic Analysis Using PureGen Versus Autologous Bone in Posterolateral Fusion (PLF)
The purpose of this study is to evaluate the rate and quality of fusion of PureGen Osteoprogenitor Cell Allograft, compared to autograft bone in instrumented posterolateral fusion (PLF) procedures.
- Trial name
- NCT01294007
- Testing
- PureGen Osteoprogenitor Cell Allograft, Autograft bone
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Alphatec Spine, Inc.
Osteoarthritis, Knee, Knee Degenerative Disease
Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stem Cells
In this prospective study we aim to evaluate the feasibility and safety of the implantation of 40 millions MSV in knees with osteoarthritis of grade II-IV (Kellgren and Lawrence).
- Conditions
- Osteoarthritis, Knee, Knee Degenerative Disease, Knee Osteoarthritis
- Trial name
- KDD&MSV (NCT01183728)
- Testing
- Autologous bone marrow mesenchymal stem cells (MSV)
- Where
- 2 sites in Spain
- Volunteers
- 12 people
- Sponsor
- Red de Terapia Celular
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 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
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
Spinal Stenosis
A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis
The purpose of this study is to evaluate the safety and effectiveness of the In-Space compared to the X STOP Interspinous Process Distraction (IPD) device ("X STOP") for the treatment of patients experiencing intermittent…
- Trial name
- In-Space (NCT00697827)
- Testing
- Interspinous Spacer device, Interspinous Process Distraction Device
- Where
- 10 sites in United States
- Volunteers
- 44 people
- Sponsor
- Synthes USA HQ, Inc.
Spinal Stenosis
Clinical Trial Comparing Decompression With and Without Coflex™ Interlaminar Technology Treating Lumbar Spinal Stenosis
A 2 year comparative evaluation of clinical outcome in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with and without additional stabilization using the coflex® Interlaminar…
- Trial name
- NCT01316211
- Testing
- Implantation of coflex™ after surgical decompression, Surgical decompression
- Where
- 8 sites in Germany
- Volunteers
- 246 people
- Sponsor
- Paradigm Spine
Degenerative Disc Disease
Activ-L™ Artificial Disc Treatment of Degenerative Disc Disease in the Treatment of Degenerative Disc Disease
The purpose of this study is to learn whether an investigational device called the Activ-L Artificial Disc is safe and effective in the treatment of degenerative disc disease of the lower (lumbar) spine.
- Trial name
- NCT00589797
- Testing
- Activ-L Artificial Disc, ProDisc-L Total Disc Replacement or Charité Artificial Disc
- Where
- 17 sites in United States
- Volunteers
- 376 people, healthy volunteers welcome
- Sponsor
- Aesculap Implant Systems
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 Disc Disease
Intradiscal rhGDF-5 Phase I/II Clinical Trial
Study to show the effectiveness and safety of a single injection of rhGDF5 into a degenerating single spinal disc in treating lumbar level degenerative disc disease
- Trial name
- NCT00813813
- Testing
- Intradiscal rhGDF-5
- Where
- 8 sites in United States
- Volunteers
- 32 people
- Sponsor
- DePuy 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