Clinical trials: Spine Deformity
Degenerative Disc Disease, Trauma (Including Fractures)
BIO4 Clinical Case Study: Cervical Spine
The goal of this study is to investigate the efficacy of BIO4 bone matrix in patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery.
- Conditions
- Degenerative Disc Disease, Trauma (Including Fractures), Spondylolisthesis
- Trial name
- NCT03077204
- Testing
- 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window)., Aviator Anterior Cervical Plating System
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Seton Healthcare Family
Postoperative Ileus
Subcutaneous Methylnaltrexone Versus Placebo for Postoperative Ileus Prevention
This randomized controlled trial will prospectively evaluate the clinical benefit for subcutaneous methylnaltrexone (MNTX) in counteracting the obstipatory (causing constipation) effects of spinal surgery without increasing…
- Trial name
- NCT03852524
- Testing
- Methylnaltrexone
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Ohio State University
Spine Deformity
A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains
The examination of the ability of the OrthoPAT® blood collection device to decrease the transfusion rate and volume of adults undergoing posterior spine surgery for deformity correction of 6 levels or more.
- Trial name
- NCT02286102
- Testing
- OrthoPAT, Constavac
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Hospital for Special Surgery, New York
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
Adolescent Idiopathic Scoliosis
MESA Rail™ AIS Study - Preservation of Curve Correction
To evaluate the restoration and maintenance of thoracic kyphosis and coronal curve correction demonstrated through the surgical implantation of the K2M MESA Rail™ Deformity System as compared to literature reported outcomes for…
- Trial name
- NCT02062606
- Testing
- MESA Rail™ Deformity System
- Volunteers
- 188 people
- Sponsor
- K2M, Inc.
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
Spinal Metastases, Vertebral Metastases
Stereotactic Body Radiotherapy for Spine Tumors
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of spine metastases and benign spine tumors.
- Conditions
- Spinal Metastases, Vertebral Metastases, Benign Spinal Tumors, Chordoma
- Trial name
- NCT01347307
- Testing
- SBRT for Benign Extradural Spine Tumors, SBRT for Vertebral/Paraspinal Metastases
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Mercy Research
Hereditary Breast and Ovarian Cancer Syndrome, Osteoporosis
Zoledronate or Observation in Maintaining Bone Mineral Density in Patients Who Are Undergoing Surgery to Remove Both Ovaries
This randomized phase II trial is studying zoledronate to see how well it works compared to observation in maintaining bone mineral density in patients who are undergoing surgery to remove both ovaries.
- Conditions
- Hereditary Breast and Ovarian Cancer Syndrome, Osteoporosis, Ovarian Carcinoma
- Trial name
- NCT00305695
- Testing
- Laboratory Biomarker Analysis, Zoledronic Acid
- Where
- 95 sites in United States
- Volunteers
- 160 people
- Sponsor
- Gynecologic Oncology Group
Spinal Deformity
Incisional Negative Pressure Wound Therapy
The purpose of this study is to evaluate the outcome of incisional negative pressure wound therapy in preventing surgical site infections and wound complications (dehiscence) in high-risk patients undergoing complex spinal…
- Trial name
- NCT01759381
- Testing
- Negative pressure wound therapy (NPWT)
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Duke University
Headache, Tumor
Dexmedetomidine and Propofol for Pediatric MRI Sedation
The purpose of this study is to compare the results of combining two anesthetic medications (dexmedetomidine and propofol) in low doses with a standard dose of a single drug that is commonly used to provide sedation/anesthesia…
- Conditions
- Headache, Tumor, Seizure Disorder, Neurofibromatoses
- Trial name
- NCT03513757
- Testing
- propofol, Dexmedetomidine, Glycopyrrolate
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Medical College of Wisconsin
Neurofibromatosis Type 1, Plexiform Neurofibroma
AZD2171 in Treating Patients With Neurofibromatosis Type 1 and Plexiform Neurofibroma and/or Neurofibroma Near the Spine
This phase II trial is studying how well AZD2171 works in treating patients with neurofibromatosis type 1 and plexiform neurofibroma and/or neurofibroma near the spine.
- Conditions
- Neurofibromatosis Type 1, Plexiform Neurofibroma, Spinal Cord Neurofibroma
- Trial name
- NCT00326872
- Testing
- Cediranib Maleate
- Where
- 9 sites in United States
- Volunteers
- 26 people
- Sponsor
- National Cancer Institute (NCI)
Low Bone Mass, Low Bone Mineral Density
Study to Compare the Efficacy and Safety of DenosumAb Versus Placebo in Males With Osteoporosis
The purpose of this study is to assess how effective and safe denosumab is in a population of males with low bone mass at risk of fracture.
- Conditions
- Low Bone Mass, Low Bone Mineral Density, Males With Osteoporosis, Osteopenia
- Trial name
- NCT00980174
- Testing
- 60 mg denosumab
- Volunteers
- 242 people
- Sponsor
- Amgen
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
Low Back Pain, Lumbosacral Radiculopathy
A Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief
The purpose of this study is to collect information about how patients feel when doctors manage their pain after lumbar spine surgery using a combination of EXPAREL® and bupivacaine injected into the lumbar spine at the end of…
- Conditions
- Low Back Pain, Lumbosacral Radiculopathy, Lumbar Disc Degeneration, Lumbar Disc Herniation
- Trial name
- NCT03514277
- Testing
- Exparel, Bupivacaine
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Virtua Health, Inc.
Acute Instabilities Thoracic, Lumbar and Sacral Spine, Chronic Instabilities Thoracic, Lumbar and Sacral Spine
A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System
This postmarket surveillance study is being conducted to evaluate the TRANSITION Stabilization System as an adjunct to fusion in the treatment of acute or chronic instabilities or deformities of the thoracic, lumbar and sacral…
- Conditions
- Acute Instabilities Thoracic, Lumbar and Sacral Spine, Chronic Instabilities Thoracic, Lumbar and Sacral Spine, Deformities of the Thoracic, Lumbar and Sacral Spine
- Trial name
- NCT02184520
- Testing
- TRANSITION, REVERE
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Globus Medical Inc
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
Cervical Spine Fusion
Measuring Dysphagia After ACDF Surgery Through A Novel Wearable Sensor
The purpose of this study is to assess the function and reliability of a noninvasive, skin-like electronic sensor. The investigators hypothesize that this skin sensor will address an unmet need to wirelessly and noninvasively…
- Trial name
- NCT04921800
- Testing
- Anterior Cervical Discectomy & Fusion, Application of ADAM mechanoacoustic skin sensor
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Northwestern University
Spinal Deformity
Spinal Deformity Intraoperative Monitoring.
A multicenter, international prospectively collected patient cohort undergoing high-risk spinal cord level surgery or spinal osteotomy procedures will be enrolled to establish the incidence of intraoperative alerts in high-risk…
- Trial name
- NCT03880292
- Testing
- Document intraoperative Maneuvers
- Where
- 24 sites in United States, Australia and 12 more
- Volunteers
- 592 people
- Sponsor
- AO Foundation, AO Spine
Neuromuscular Diseases, Neuromuscular Scoliosis
Efficacy of Surgical Treatment by Different Pedicle Screw Systems in Pediatric Neuromuscular Spinal Deformity
This study was sponsored by Federal state budgetary institution "Russian scientific center for traumatology and orthopedics" n.a. acad. G.A. Ilizarov" of the Ministry of Health of Russian Federation.
- Trial name
- NCT03863496
- Testing
- Scoliosis surgery
- Where
- Russia
- Volunteers
- 71 people
- Sponsor
- Ilizarov Center
Adult Spinal Deformity
Tranexamic Acid Dosing in Adult Spinal Deformity Surgery
The purpose of this study is to evaluate two dosing protocols for tranexamic acid (TXA), an anti-fibrinolytic used to decrease blood loss in adult patients undergoing complex, reconstructive spinal fusion surgeries.
- Trial name
- NCT02053363
- Testing
- Tranexamic Acid (Cyklokapron)
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Washington University School of Medicine