Clinical trials: Fractures, Compression
Vertebral Compression Fractures, Osteoporotic Vertebral Compression Fractures
Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant
The RECONSTRUCT study is a multi-center, prospective, single arm, post-market, pilot study to evaluate clinical and radiologic outcome data regarding the use of the Vertebral Implant PEEK (VIP) implant in the treatment of…
- Trial name
- RECONSTRUCT (NCT05337696)
- Testing
- Vertebral Implant PEEK Procedure, Vertebral Implant PEEK (VIP) implant
- Where
- 4 sites in United States
- Volunteers
- 23 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Postoperative Pain, Carpal Tunnel Release
Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol for Carpal Tunnel and Distal Radius Fracture Surgeries
The purpose of this study is to determine the efficacy of intra-operative administration of IV tylenol and/or IV toradol in minimizing post-operative pain for carpal tunnel patients and distal radius fracture patients.
- Conditions
- Postoperative Pain, Carpal Tunnel Release, Distal Radius Fracture
- Trial name
- NCT02313675
- Testing
- Acetaminophen, Ketorolac Tromethamine, Saline
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- John Fowler
Spinal Fractures, Fractures, Compression
The Kiva® System as a Vertebral Augmentation Treatment
The purpose of this study is to evaluate the safety and effectiveness of the Kiva VCF Treatment system in comparison to balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures of the thoracic or…
- Conditions
- Spinal Fractures, Fractures, Compression, Back Injuries
- Trial name
- KAST (NCT01123512)
- Testing
- Vertebral augmentation
- Where
- 21 sites in United States, Belgium and 3 more
- Volunteers
- 300 people
- Sponsor
- Benvenue Medical, Inc.
LC Pelvic Fracture
Pelvis RCT: Impact of Surgery on Pain in Lateral Compression Type Pelvic Fractures
Lateral compression type pelvic ring injuries remain the most common type of pelvic fractures encountered. There is a substantial amount of controversy surrounding the treatment of these injuries and there is evidence that both…
- Trial name
- NCT02625766
- Testing
- LC fracture surgical fixation, LC fracture non-operative management
- Where
- 2 sites in United States
- Volunteers
- 95 people
- Sponsor
- University of Maryland, Baltimore
Bone Metastases
A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone metastases in subjects with advanced breast cancer.
- Trial name
- NCT00321464
- Testing
- Denosumab, Zoledronic Acid
- Volunteers
- 2,049 people
- Sponsor
- Amgen
Compression Fracture
Comparison of Treatments of Osteoporotic Compression Fracture Using Rigid Brace, Soft Brace, and no Brace
The treatment outcomes in the treatment without brace would be non-inferior to those in use of rigid or soft brace.
- Trial name
- NCT02049931
- Testing
- No brace treatment, Rigid brace, Soft brace
- Volunteers
- 60 people
- Sponsor
- Seoul National University Hospital
Vertebral Compression Fractures
OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture
The OsseoFix Spinal Fracture Reduction System facilitates the treatment of spinal fractures by providing internal fixation and stabilization using a titanium implant in conjunction with OsseoFix+™ polymethylmethacrylate (PMMA)…
- Trial name
- OsseoFix (NCT00961714)
- Testing
- OsseoFix Spinal Fracture Reduction System
- Where
- 11 sites in United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Alphatec Spine, Inc.
Cancer, Spinal Disease
Anderson Circulating Tumor Cell Burden (CTCB) Study
Phase 1 - Optimization Phase: Primary Objective: The primary objective of Phase 1 of this study is to determine the time point at which maximal Circulating Tumor Cell Burden (CTCB) occurs following standard vertebroplasty and…
- Conditions
- Cancer, Spinal Disease, Vertebral Compression Fractures
- Trial name
- NCT00819832
- Testing
- Kyphoplasty, Vertebroplasty, Cavity SpineWand
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- M.D. Anderson Cancer Center
Vertebral Body Compression Fractures
KAVIAR Study - Kyphoplasty And Vertebroplasty In the Augmentation and Restoration of Vertebral Body Compression Fractures
Patients with osteoporotic vertebral body compression fractures will be randomly assigned to treatment with balloon kyphoplasty or vertebroplasty.
- Trial name
- NCT00323609
- Testing
- Vertebroplasty, Kyphoplasty
- Where
- 26 sites in United States, Canada
- Volunteers
- 404 people
- Sponsor
- Medtronic Spine LLC
Back Pain
Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis
The purpose of this study is to determine the effectiveness and safety of tapentadol immediate release (IR) as compared with placebo and oxycodone IR in patients with acute pain caused by vertebral compression fractures (VCF)…
- Trial name
- NCT00771758
- Testing
- oxycodone IR, tapentadol IR
- Where
- 37 sites in United States
- Volunteers
- 108 people
- Sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
Post-traumatic Carpal Tunnel Syndrome, Complex Regional Pain Syndrome
Use of Compression Glove to Prevent Complications After Distal Radius Fractures: a Randomized Controlled Trial
Distal radius fractures (DRF) are the most common type of fracture in the human body, and a large proportion of DRFs result in complications.
- Conditions
- Post-traumatic Carpal Tunnel Syndrome, Complex Regional Pain Syndrome, Edema
- Trial name
- NCT01118715
- Testing
- Compression glove
- Where
- United States
- Volunteers
- 128 people
- Sponsor
- J&M Shuler
Vertebral Body Compression Fractures (VCFs)
Medtronic SCORE Study - Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty
The objective of this study is to measure the effect that the scraping and scoring of vertebral cancellous bone using the Kyphon® Curette has on vertebral body anatomy height restoration and angular deformity correction during a…
- Trial name
- MDTSCORE (NCT00810043)
- Testing
- Kyphon® Curette
- Where
- 13 sites in United States, Belgium and 1 more
- Volunteers
- 120 people
- Sponsor
- Medtronic Spine LLC
Compression Fracture of Vertebral Body, Osteoporosis
Evaluation of Outcomes for Quality of Life and Activities of Daily Living for BKP in the Treatment of VCFs
The study objective is to collect and report 12-month outcomes pertaining to activities of daily living, quality of life, and safety parameters in a Medicare population to be treated with balloon kyphoplasty in the treatment of…
- Conditions
- Compression Fracture of Vertebral Body, Osteoporosis, Cancer
- Trial name
- EVOLVE (NCT01871519)
- Testing
- Balloon kyphoplasty
- Where
- 25 sites in United States
- Volunteers
- 354 people
- Sponsor
- Medtronic Spinal and Biologics
Lumbar Post-Laminectomy Syndrome, Chronic Low Back Pain
Determining the Prognostic Value of Continuous Intrathecal Infusion
The purpose of this study will be to determine the efficacy and the prognostic value of a continuous intrathecal prognostic infusion test in an in-hospital setting for selecting patients who would have better long term outcomes…
- Conditions
- Lumbar Post-Laminectomy Syndrome, Chronic Low Back Pain, Vertebral Compression Fracture, Failed Back Surgery Syndrome
- Trial name
- NCT03523000
- Testing
- Continuous intrathecal prognostic infusion test, Bupivacaine, Fentanyl
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- University Hospitals Cleveland Medical Center
Cancer, Hematologic Malignancies
Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone disease from multiple myeloma.
- Conditions
- Cancer, Hematologic Malignancies, Multiple Myeloma, Oncology
- Trial name
- NCT01345019
- Testing
- Denosumab, Zoledronic acid, Denosumab (for the open-label treatment phase)
- Where
- 309 sites in United States, Australia and 27 more
- Volunteers
- 1,718 people
- Sponsor
- Amgen
Closed Transverse Fracture of Shaft of Tibia
Union Rate of Transverse Tibia Fracture
The investigators will compare the three methods of seating a tibial nail - Backslapping or Backslapping with Dynamic Locking or Internal Compression.
- Trial name
- NCT03042533
- Testing
- Conventional Compression, Standard Backslapping, Dynamic Locking with Backslapping
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Washington
Bone Metastases
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in subjects with advanced cancer and multiple…
- Trial name
- NCT00330759
- Testing
- Denosumab, Zoledronic Acid
- Volunteers
- 1,779 people
- Sponsor
- Amgen
Surgical Complication, Paresthesia
Trial of Bilateral Sagittal Split Osteotomy Induced Paresthesia Using Ultrasonic vs. Reciprocating Saw Instrumentation
The aim of this prospective study is to analyze the postoperative paresthesias experienced in patients who undergo bilateral sagittal split osteotomies (BSSO) using an ultrasonic saw, versus a reciprocating saw.
- Conditions
- Surgical Complication, Paresthesia, Fracture, Nerve Injury
- Trial name
- NCT05205616
- Testing
- Sonopet ultrasonic saw, Reciprocating saw
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Vertebral Compression Fracture
Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures
Balloon kyphoplasty for the treatment of patients with osteoporotic vertebral compression fractures has been shown to be successful in providing acute pain relief, enabling improved function, and restoring of vertebral body…
- Trial name
- NCT01383616
- Testing
- Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- Hospital for Special Surgery, New York
Cancer, Spinal Fractures
CAFE Study - Cancer Patient Fracture Evaluation
The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, vertebral compression fractures (VCFs) as compared to standard non-surgical therapy in patients…
- Trial name
- CAFE (NCT00211237)
- Testing
- Balloon Kyphoplasty, Non Surgical Management
- Where
- 20 sites in United States, Australia and 6 more
- Volunteers
- 134 people
- Sponsor
- Medtronic Spine LLC