Clinical trials: Vertebra; Degeneration
Lumbar Spine Degeneration
MOTUS Total Joint Replacement Investigational Device Exemption Study
This study is designed to collect safety and efficacy data on patients who plan to undergo a single-level total joint replacement of the lumbar spine using the MOTUS device (MOTUS Total Joint Replacement procedure) to demonstrate…
- Trial name
- NCT05438719
- Testing
- MOTUS Total Joint Replacement
- Where
- 14 sites in United States
- Volunteers
- 158 people
- Sponsor
- 3Spine
Lumbar Spine Stenosis, Lumbar Spine Degeneration
OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults
The proposed research is an important extension of an ongoing perioperative personalized analgesia and intravenous opioid pharmacogenetic research.
- Trial name
- NCT05452694
- Where
- 3 sites in United States
- Volunteers
- 235 people
- Sponsor
- OpalGenix, Inc
Degenerative Disc Disease
Pilot Study of rhBMP-2/BCP in Patients With Spinal Degeneration With Instability Requiring Surgical Fusion
This study is designed to generate data relating to patient safety, bone generating activity associated with the use of the rhBMP-2/BCP device as compared to autograft and to evaluate the feasibility of conducting a larger…
- Trial name
- NCT01495234
- Testing
- rhBMP-2/BCP device
- Volunteers
- 15 people
- Sponsor
- Medtronic Spinal and Biologics
Vertebral Cervical Fusion Syndrome, Degenerative Disc Disease
Study Using the CervicalStim Device Following Cervical Fusion
This study examines the effect of adjunctive use of the CervicalStim bone growth stimulator on cervical fusion rate in high risk subjects who have undergone cervical fusion surgery.
- Trial name
- NCT03177473
- Testing
- CervicalStim bone growth stimulator
- Where
- United States
- Volunteers
- 211 people
- Sponsor
- Orthofix Inc.
Degenerative Disc Disease, Spondylolisthesis
Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF)
This is a first-in-human, dose escalation clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) when combined with…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis
- Trial name
- NCT00549913
- Testing
- NeoFuse, posterolateral spinal fusion with instrumentation
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Mesoblast, Ltd.
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
Lumbar Spine Degeneration
3Spine Lumbar Fusion Real World Evidence Study
This study is designed to collect real world evidence (RWE) safety and efficacy data on patients who plan to undergo a single-level Transforaminal lumbar interbody fusion (TLIF) or Posterior lumbar interbody fusion (PLIF)…
- Trial name
- NCT04823858
- Testing
- Lumbar Interbody Fusion
- Where
- 20 sites in United States
- Volunteers
- 176 people
- Sponsor
- 3Spine
Scoliosis, Back Pain
InterFuse® S and T for the Treatment of Scoliosis, Spondylolisthesis and Degenerative Disc Disease (DDD)
The primary objective of this prospective, post-market study is to collect data to assess the long term outcome of a broad contact modular interbody device in the form of the InterFuse S™ or InterFuse T™ device in patients…
- Trial name
- NCT02659722
- Testing
- InterFuse
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Vertebral Technologies, Inc.
Degenerative Disc Disease
rhBMP-2/CRM/CD HORIZON® Spinal System Pilot Study (2-Level)
The purpose of this study is to evaluate the feasibility of using the investigational implant (rhBMP-2/CRM with the CD HORIZON® Spinal System) as a method of facilitating posterolateral lumbar spinal fusion at two adjacent…
- Trial name
- NCT01491568
- Testing
- rhBMP-2/CRM/CD HORIZON® Spinal System
- Volunteers
- 29 people
- Sponsor
- Medtronic Spinal and Biologics
Lumbar Spine Degeneration
Study Using the SpinalStim Device Following Lumbar Fusion Surgery
This study examines the effect of adjunctive use of the SpinalStim bone growth stimulator on lumbar fusion rate in high risk subjects who have had lumbar fusion surgery.
- Trial name
- NCT03176303
- Testing
- SpinalStim
- Where
- United States
- Volunteers
- 206 people
- Sponsor
- Orthofix Inc.
Degenerative Disc Disease, Lumbar Disc Disease
LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
The objective of this study is to evaluate the safety and effectiveness of LDGraft (investigational device) compared to 100% human tissue product allograft bone (control) when applied in an ALIF procedure in the treatment of…
- Conditions
- Degenerative Disc Disease, Lumbar Disc Disease, Spine Disease, Lumbar Spine Degeneration
- Trial name
- RESTORE (NCT06462729)
- Testing
- LDGraft, Allograft Bone
- Where
- 4 sites in United States, Australia
- Volunteers
- 40 people
- Sponsor
- Locate Bio Pty Ltd
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
Disc Degenerative Disease, Spondylolisthesis
A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
The primary objective of this study is to demonstrate that the efficacy and safety of Spine fusion system manufactured in China is no inferior than imported product.
- Conditions
- Disc Degenerative Disease, Spondylolisthesis, Spinal Fracture, Spinal Deformity
- Trial name
- NCT02252185
- Testing
- Johnson&Johnson Medical Suzhou made Spine Fusion System, Imported EXPEDIUM screws and OPAL cage
- Where
- 8 sites in China
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Medical (Suzhou) Ltd.
Degenerative Instability, Spondylolisthesis
PMCF Study on the Safety and Performance of CESPACE 3D
Prospective, pure data collection of all CeSPACE 3D patients in selected centers (not interventional, multicenter)
- Conditions
- Degenerative Instability, Spondylolisthesis, Post-discectomy Syndrome, Post-traumatic Instabilities
- Trial name
- CATALINA (NCT04477447)
- Where
- 2 sites in Germany
- Volunteers
- 101 people
- Sponsor
- Aesculap AG
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, Chronic Lower Back Pain
Intervertebral DXM Gel Injection in Adults With Painful Lumbar Degenerative Disc Disease
The purpose of this study is to assess the safety and the efficacy of an hydrogel (double cross-link microgel - DXM) injection into the intervertebral disc (IVD) space in patients with painful lumbar degenerative disc disease…
- Conditions
- Degenerative Disc Disease, Chronic Lower Back Pain, Discogenic Pain, Intervertebral Disc Degeneration
- Trial name
- DXM gel (NCT04727385)
- Testing
- Double Crosslink Microgel
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Gelmetix
Vertebra; Degeneration, Spinal Trauma
SpineTRACK Registry - Spinal Outcomes Registry
The Spine TRACK Spinal Surgery Registry is a prospective multi-center observational data collection initiative, to capture clinical and radiographic outcomes in candidates for spine surgery with degenerative, deformity, and…
- Conditions
- Vertebra; Degeneration, Spinal Trauma, Spinal Deformity
- Trial name
- NCT01372592
- Testing
- Surgery
- Where
- 28 sites in United States, Brazil
- Volunteers
- 8,079 people
- Sponsor
- NuVasive
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
Spine Degeneration, Spine Spondylosis Thoracic
Clariance ErYs Registry
International, prospective, single arm, multicenter and observational Post-Market Clinical Follow-up (PMCF). The overall objective of this study is to collect preoperative, intraoperative and postoperative (at 9 weeks, 6 months…
- Conditions
- Spine Degeneration, Spine Spondylosis Thoracic, Spinal Deformity, Spinal Tumor
- Trial name
- ErYs (NCT05170815)
- Testing
- Spine surgery
- Where
- France
- Volunteers
- 760 people
- Sponsor
- Clariance
Spine Disease, Spinal Fusion
Validity and Accuracy of a Machine Learning Predictive Model in the Exploitation of Patients Related Outcomes in Spine Surgery
The objective of the study is the establishment, optimization and prospective evaluation of a digital predictive platform capable of providing for each lumbar spine operated patient a clinical predictive status: Patient green…
- Conditions
- Spine Disease, Spinal Fusion, Surgery, Spine Degeneration
- Trial name
- DeepSurgery (NCT05166018)
- Testing
- SuMO Patient
- Where
- 2 sites in France
- Volunteers
- 174 people
- Sponsor
- Cortexx Medical Intelligence