Clinical trials: Degenerative Spinal Disease
Degenerative Disc Disease
Interbody Systems: Post Market Clinical Follow-up Study
This is a prospective, multi-center study of subjects who will undergo spinal fusion surgery utilizing Stryker Interbody Systems that require post market clinical follow up (PMCF).
- Trial name
- NCT04911257
- Testing
- Cervical or Lumbar Spinal fusion
- Where
- 4 sites in United States
- Volunteers
- 28 people
- Sponsor
- K2M, Inc.
Degenerative Disc Disease
Long-term Assessment of BDyn Dynamic Stabilization Device in Patients With Lumbar Degenerative Disc Disease
The goal of this clinical trial is to estimate the cumulative reoperation rate at upper adjacent segment level in patients treated with BDyn dynamix stabilization for lumbar degenerative disc diseases over long-term follow-up.
- Trial name
- MOBIDYN (NCT07580664)
- Testing
- Dynamic Lumbar Stabilization Device
- Volunteers
- 150 people
- Sponsor
- Cousin Biotech
Degenerative Disc Disease
Study of the ReGelTec HYDRAFIL System
A study designed to treat patients with back pain associated with degenerative lumbar disc disease.
- Trial name
- NCT04984629
- Testing
- HYDRAFIL
- Where
- Canada
- Volunteers
- 35 people
- Sponsor
- ReGelTec, Inc.
Degenerative Disc Disease
Patient Outcomes Using an Expandable Spacer
This study is a post-market clinical follow-up study. The data collected from this study will serve the purpose of confirming safety and performance of the ALTERA™ Expandable implant.
- Trial name
- NCT03162666
- Testing
- ALTERA
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Globus Medical Inc
Solid Tumors
A Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin in Patients With Advanced Solid Tumors
In the laboratory, Kevetrin activates p53, a tumor suppressor protein that has an important role in protecting the body. p53 functions by activating proteins that repair DNA and kill cells that have genetic mutations such as in…
- Trial name
- NCT01664000
- Testing
- thioureidobutyronitrile
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Cellceutix Corporation
Lumbar Disc Disease
Single Center Study Comparing MOBIS II ST vs MOBIS PEEK
Prospective randomized clinical study comparing SIGNUS MOBIS PEEK vs SIGNUS MOBIS II ST in patients with Degenerative Disc Disease at one or two contiguous levels from L2-S1
- Trial name
- MOBIS_US (NCT02852187)
- Testing
- SIGNUS MOBIS PEEK Cage, SIGNUS MOBIS II ST Cage
- Where
- United States
- Sponsor
- Signus Medizintechnik GmbH
Spinocerebellar Ataxias, Spinocerebellar Ataxia Type 1
Troriluzole in Adult Participants With Spinocerebellar Ataxia
The purpose of this study is to compare the efficacy of Troriluzole (200 mg once daily) versus placebo after 48 weeks of treatment in subjects with spinocerebellar ataxia (SCA).
- Conditions
- Spinocerebellar Ataxias, Spinocerebellar Ataxia Type 1, Spinocerebellar Ataxia Type 2, Spinocerebellar Ataxia Type 3
- Trial name
- NCT03701399
- Testing
- troriluzole
- Where
- 23 sites in United States, China
- Volunteers
- 299 people
- Sponsor
- Biohaven Pharmaceuticals, Inc.
Spinal Lumbar Stenosis, Claudication, Intermittent
Evaluation of Safety and Effectiveness of Lobster Dynamic Interspinous Spacer in Lumbar Spinal Stenosis
The aim of this study is to demonstrate the safety and effectiveness of the Lobster interspinous spacer device for the treatment of Lumbar Spinal Stenosis in comparison to an SSED-based performance goal.
- Trial name
- LB2CT01 (NCT05587465)
- Testing
- Lobster Device
- Where
- Italy
- Volunteers
- 210 people
- Sponsor
- Diametros Medical srl
Degenerative Disc Disease
Clinical Evaluation of Fortilink® TETRAfuse® Interbody Fusion Device in Subjects With Degenerative Disc Disease
This is a prospective, multi-center, non-randomized post-market evaluation designed to collect and evaluate data on the safety and performance of the Fortilink IBF System with TETRAfuse 3D Technology.
- Trial name
- FORTE (NCT03761563)
- Testing
- Fortilink IBF System with TETRAfuse Technology
- Where
- 14 sites in United States
- Volunteers
- 15 people
- Sponsor
- Xtant Medical
FXN Gene, FRDA
Biomarker for Friedreich's Ataxia (BioFridA)
International, multicenter, observational, longitudinal monitoring study to identify biomarker/s for Friedreich's Ataxia and to explore the clinical robustness, specificity, and long-term variability of these biomarker/s
- Conditions
- FXN Gene, FRDA, Hereditary Diseases
- Trial name
- BioFridA (NCT04548921)
- Where
- Lebanon
- Volunteers
- 1,000 people
- Sponsor
- CENTOGENE GmbH Rostock
Back Pain, Chronic Low Back Pain
Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System
The purpose of this investigation is to establish the safety and efficacy of the Biostat System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal disc disruptions (IDD) by comparing safety and…
- Conditions
- Back Pain, Chronic Low Back Pain, Internal Disc Disruption, Degenerative Disc Disease
- Trial name
- NCT01011816
- Testing
- BIOSTAT BIOLOGX, Saline
- Where
- 20 sites in United States
- Volunteers
- 220 people
- Sponsor
- Spinal Restoration, Inc.
Degenerative Disc Disease
Investigation of DEXA-C Anterior Cervical Interbody System
FDA Cleared interbody product for the cervical spine, designed to match a patients DEXA scan for increase in fusion rate.
- Trial name
- DEXA-C (NCT05883436)
- Testing
- DEXA-C Cervical Interbody System
- Where
- 4 sites in United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Aurora Spine and Pain
Degenerative Disc Disease, Chronic Low-back Pain
Discure Technologies Feasibility Study for DDD
The objective of this study is to evaluate the safety and performance of the Discure System therapy in subjects with early to moderate degeneration of the disc (DDD).
- Conditions
- Degenerative Disc Disease, Chronic Low-back Pain, Discogenic Pain
- Trial name
- NCT06127745
- Testing
- Discure System
- Volunteers
- 20 people
- Sponsor
- Discure Technologies Ltd.
SCD
A Phase II Double Blind Comparative Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
The purpose of this study is to evaluate the efficacy and safety of KPS-0373 compared to placebo in patients with Spinocerebellar Degeneration (SCD).
- Trial name
- NCT01384435
- Testing
- KPS-0373
- Where
- Japan
- Volunteers
- 200 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
Spinal Diseases
A-MAV™ Anterior Motion Segment Replacement
The purpose of this clinical trial is to collect safety and effectiveness data concerning the A-MAV™ Anterior Motion Segment Replacement device as a method of treating patients with lumbar degenerative disc disease at one level…
- Trial name
- NCT00635934
- Testing
- A-MAV™ disc
- Where
- 3 sites in United States
- Volunteers
- 53 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Disc Disease, Spinal Stenosis
Comparison of nanOss Bioactive With Autograft and Bone Marrow Aspirate to Autograft in the Posterolateral Spine
nanOss Bioactive is approved for use in the U.S. The purpose of this study is to compare fusion results in the posterolateral spine using nanOss Bioactive mixed with autograft bone and bone marrow aspirate (BMA) on one side and…
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT01968993
- Testing
- nanOss Bioactive - posterolateral gutter
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Pioneer Surgical Technology, Inc.
Spinocerebellar Ataxias, Spinocerebellar Ataxia Genotype Type 1
Trial in Adult Participants With Spinocerebellar Ataxia (SCA)
The primary purpose of this study was to compare the efficacy of BHV-4157 (Troriluzole) 140 milligrams (mg) once daily versus placebo after 8 weeks of treatment in participants with spinocerebellar ataxia (SCA).
- Conditions
- Spinocerebellar Ataxias, Spinocerebellar Ataxia Genotype Type 1, Spinocerebellar Ataxia Genotype Type 2, Spinocerebellar Ataxia Genotype Type 3
- Trial name
- NCT02960893
- Testing
- Troriluzole
- Where
- 18 sites in United States
- Volunteers
- 141 people
- Sponsor
- Biohaven Pharmaceuticals, Inc.
Intervertebral Disc Degeneration
Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease
The goal of this observational study is to confirm the safety and efficacy of the Hexanium TLIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal…
- Trial name
- TLIF (NCT05997121)
- Testing
- Transforaminal lumbar interbody fusion
- Where
- 6 sites in France, Switzerland
- Volunteers
- 187 people
- Sponsor
- SPINEVISION SAS
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
Spinocerebellar Ataxias
Real-World Data Study of Troriluzole-Treated Patients With Spinocerebellar Ataxia (SCA) Compared to a Matched Natural History Control
The purpose of this study is to leverage two sources of real-world data (RWD) to assess the effectiveness of troriluzole after three years of treatment in patients with SCA by comparison to an external control of untreated…
- Trial name
- NCT06529146
- Testing
- BHV-4157
- Where
- United States
- Volunteers
- 909 people
- Sponsor
- Biohaven Therapeutics Ltd.