Clinical trials: Spine
Spinal Disease
Stronger Together Global Registry
A global, prospective, non-randomized, multicenter, observational, post-market, medical record review registry evaluating real-world evidence for SeaSpine products.
- Trial name
- NCT04364295
- Testing
- Spinal Surgery with SeaSpine product
- Where
- 2 sites in United States
- Volunteers
- 2,285 people
- Sponsor
- SeaSpine, Inc.
Scoliosis; Adolescence, Degenerative Disc Disease
Personalized Spine Study Group Registry
As a registry, the primary objective of the study is a data collection initiative. The study will collect clinical and radiographic outcomes of patients implanted with Medicrea's PSR.
- Conditions
- Scoliosis; Adolescence, Degenerative Disc Disease, Spinal Fusion, Kyphoscoliosis
- Trial name
- NCT03843476
- Testing
- Patient Specific Rod
- Sponsor
- Medicrea, USA Corp.
Central Nervous System Diseases
Safety and Efficacy of MultiHance in Pediatric Patients
The purpose of this study was to assess the safety and enhancing properties of the magnetic resonance imaging (MRI) contrast agent MultiHance in children aged 2 to 17 years having central nervous system (CNS) disorders.
- Trial name
- NCT00323310
- Testing
- gadobenate dimeglumine
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- Bracco Diagnostics, Inc
Hyperkyphosis, Hyperlordosis
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex
Multicenter, multinational Post-Market Clinical Follow-Up (PMCF) study on the safety and performance of Ennovate® Complex - A prospective, pure data collection of all Ennovate® scoliosis patients in selected centers (not…
- Conditions
- Hyperkyphosis, Hyperlordosis, Congenital Scoliosis, Neuromuscular Scoliosis
- Trial name
- COSINE (NCT05281757)
- Testing
- posterior stabilization for the cervical spine
- Where
- 2 sites in Czechia, Malaysia
- Volunteers
- 200 people
- Sponsor
- Aesculap AG
Osteogenesis Imperfecta
Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI
This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI to evaluate efficacy and safety of denosumab.
- Trial name
- OI (NCT02352753)
- Testing
- Denosumab
- Where
- 49 sites in United States, Australia and 11 more
- Volunteers
- 153 people
- Sponsor
- Amgen
Degenerative Spine Disease, Spinal Deformity
Prospective, Observational Registry of Renaissance-guided Spine Surgeries
To establish an observational registry for systematic collection of clinical data from Renaissance-guided spine surgeries.
- Trial name
- NCT02212899
- Where
- 4 sites in United States
- Volunteers
- 93 people
- Sponsor
- Mazor Robotics
Magnetic Resonance Imaging, Image Enhancement
Drug Use Investigation of Gadovist.
The objectives of this study are to investigate the safety and effectiveness of Gadovist.
- Trial name
- NCT02540967
- Testing
- Gadobutrol (Gadavist/Gadovist, BAY86-4875)
- Where
- Japan
- Volunteers
- 3,357 people
- Sponsor
- Bayer
Scoliosis, Scoliosis; Adolescence
Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery With Traditional Care
The goal of this is to evaluate performance of the Pathkeeper Surgical System. The main question[s]it aims to answer are: 1) evaluate pedicle screw position Participants will in compare Experimental arm: PathKeeper System (PKS)…
- Conditions
- Scoliosis, Scoliosis; Adolescence, Scoliosis Kyphosis, Scoliosis Lumbar Region
- Trial name
- PKSforPSP (NCT06554093)
- Testing
- Medical Device - PKS
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Deep Health Ltd.
Pathological Processes
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark (Gadoversetamide) in Pediatric Patients
The objective of this study is to characterize the safety, efficacy and pharmacokinetic profiles of Optimark at the standard clinical dose of 0.1 mmol/kg in the pediatric patient population.
- Trial name
- NCT01092754
- Testing
- MRI, Gadoversetamide
- Where
- 12 sites in United States
- Volunteers
- 100 people
- Sponsor
- Guerbet
Spinal Diseases
Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions
There is a clear need in spine surgery to place pedicle screws in the right place in the spine with good accuracy to avoid damage to important structures (spinal cord, nerve roots or vertebral arteries).
- Trial name
- NCT03015142
- Testing
- New image-guidance software
- Where
- Sweden
- Volunteers
- 21 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Bone Diseases, Image
Clinical Validation of BoneMRI in the Spine
BoneMRI is a quantitative 3D MRI technique that has been developed recently by MRIGuidance BV©, which is based on a multiple gradient-echo sequence and a machine learning processing pipeline.
- Conditions
- Bone Diseases, Image, Medical Device
- Trial name
- CleverBones (NCT06745791)
- Testing
- BoneMRI
- Where
- 10 sites in Belgium, France and 2 more
- Volunteers
- 450 people
- Sponsor
- MRIguidance B.V.
Scoliosis Idiopathic
PMCF (Post-Market Clinical Follow-up) Study on The Tether™ in UK (United Kingdom)
The goal of this observational study is to collect information about The Tether™ device in participants with progressive idiopathic scoliosis, Lenke Type 1 curves.
- Trial name
- NCT05830825
- Testing
- Vertebral Body Tethering (VBT)
- Where
- 3 sites in United Kingdom
- Volunteers
- 100 people
- Sponsor
- LDR Médical SAS
Degenerative Disc Disease, Cervical Spine Degenerative Disease
Retrospective Analysis of Patients Implanted With 2 Levels of Prodisc® C Vivo Devices
The objective of the study is to evaluate the safety and post-operative performance profile of the prodisc® C Vivo after implantation in comparison to the relevant clinical literature.
- Conditions
- Degenerative Disc Disease, Cervical Spine Degenerative Disease, Symptomatic Cervical Disc Disease, Cervical Spine Degenerative Disc Disease
- Trial name
- NCT07370493
- Testing
- Prodisc C Vivo
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Centinel Spine
Degenerative Disc Disease, Spinal Stenosis
Spine Patient Outcomes Registry for Biomet/EBI (Electro-Biology, Inc)
The purpose of this patient registry is to prospectively collect data on patients who are having spinal surgery with EBI and Interpore Cross Spine Products.
- Trial name
- SPO (NCT00726284)
- Where
- 5 sites in United States
- Volunteers
- 651 people, healthy volunteers welcome
- Sponsor
- Zimmer Biomet
Degenerative Disc Disease in Cervical Spine, Stenosis Cervical Spine
PMCF Study Fortilink-SC
This study is setup to be able to gather information on the safety and performance of the Fortilink-SC Ti cage of Paradigm Spine GmbH, up to one year after the surgery.
- Trial name
- NCT07834749
- Testing
- Cervical interbody fusion surgery (standalone)
- Where
- 2 sites in Spain
- Volunteers
- 50 people
- Sponsor
- BAAT Medical Products B.V.
Spinal Fusion, Spinal Stenosis
Spine Registration Using 3D Scanning
The primary objective is to assess the capability of the device as measured by its consistency, its accuracy, and feedback from surgical staff over the study period.
- Conditions
- Spinal Fusion, Spinal Stenosis, Scoliosis, Spondylolisthesis
- Trial name
- NCT05195580
- Testing
- Optical 3D Scanner
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Advanced Scanners Inc.
Adolescent Idiopathic Scoliosis
Comparing Pedicle Screw Systems for the Treatment of Adolescent Paediatric Spine Deformity
Evaluation of the efficacy of the K2M MESA Rail™ Deformity System at improving coronal and sagittal correction of the adolescent idiopathic spine deformity in comparison to the side loading DePuy Synthes USS II pedicle screw…
- Trial name
- NCT02590380
- Testing
- MESA Rail Deformity System, DePuy Synthes USS II System
- Where
- United Kingdom
- Sponsor
- K2M, Inc.
Anemia, Blood Transfusions, Autologous
A Study to Evaluate the Safety and Effectiveness of Epoetin Alfa Versus Placebo in Facilitating the Presurgical Collection of Blood to be Used for Self-donation During Surgery on the Spine, Hip, or Knee.
The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa at doses of 150, 300, or 600 units per kilogram of body weight versus placebo in facilitating presurgical collection of blood for self-donation…
- Conditions
- Anemia, Blood Transfusions, Autologous, Orthopedic Procedures
- Trial name
- NCT00270140
- Testing
- epoetin alfa
- Volunteers
- 17 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Back Pain, Back Disorder
Clinical Trial of Dvectis Pads in Comparison to no Pad Use in Patients With Chronic Lumbar Spine Pain
1. Introduction 1.1 Description of the Trial The trial was a monocentric, open, randomized, 3-arm clinical trial that took place at the Department of Orthopaedics of the Karviná Miners' Hospital (Karvinská hornická nemocnice…
- Conditions
- Back Pain, Back Disorder, Disease Lumbar Spine
- Trial name
- NCT03947580
- Testing
- Use of the Dvectis Single pad, Use of the Dvectis Double pad, Use of no pad
- Where
- Czechia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- DD-Hippero s.r.o.
Degenerative Disc Disease, Spondylolisthesis
Quintex® Follow-up After One Year Minimum
Prospective study, not randomised, non-interventional, monocentric, investigating an intended patient cohort of 60 patients already operated on the cervical spine due to degenerative disc disease of the cervical spine down to the…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Trauma, Spinal Stenosis
- Trial name
- Quintex (NCT04489394)
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Aesculap AG