Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Crosstrees Medical Inc. |
---|---|
Information provided by: | Crosstrees Medical Inc. |
ClinicalTrials.gov Identifier: | NCT00933036 |
The clinical trial is being conducted to evaluate the performance of the Crosstrees System in reducing pain and decreasing the risk of cement leakage associated with vertebroplasty and kyphoplasty.
Condition | Intervention |
---|---|
Pathologic Fracture of the Vertebra Due to Osteoporosis |
Device: Crosstrees Pod system for PVA |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Clinical Evaluation of the Crosstrees Pod™ System for Percutaneous Vertebral Augmentation in the Treatment of Pathologic Fracture of the Vertebral Body (Levels T4 - L5) in Adult Patients |
Estimated Enrollment: | 118 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Conservative care: No Intervention
Resolution of symptoms during study mandated period of conservative care prior to treatment.
|
|
Treatment arm: Active Comparator
Percutaneous vertebral augmentation using subject devices.
|
Device: Crosstrees Pod system for PVA
Minimally invasive spine surgery
|
Every year in the United States more than 700,000 people suffer from compression fractures of the spinal column , and the number of people affected is much higher across the world. Osteoporosis is the main cause of fractures of the vertebral bodies. Other causes of vertebral fractures include malignant processes including benign lesions (hemangioma) and malignant lesions (metastatic cancers, myeloma), infections and trauma; however, osteoporosis is by far the main cause of this problem.
In a normal person, the vertebral bodies are composed of a porous structure called trabecular or spongy bone encapsulated within a thin external cap of cortical (dense) bone. In a person with osteoporosis, the trabeculae that form the central porous bone become thinner and weaker. When this occurs, the vertebral bodies begin to fracture and become deformed. This deformation of the vertebral bodies is classified into three types, according to the shape: wedge, biconcave, and crush. The degree of severity of these deformations is classified as grade A1.1, grade A1.2, or grade A1.3
The Crosstrees PVA™ Pod™ is a device designed to percutaneously provide controlled delivery of PMMA bone filler material during vertebral augmentation. The Crosstrees PVA System for Percutaneous Vertebral Augmentation (PVA) is designed for use with Crosstrees Fortibrae PMMA. The system is novel in providing the ability to control the delivery of PMMA to the vertebral body without the need for an additional permanent implant to remain within the patient. The Crosstrees System for Percutaneous Vertebral Augmentation will be used with Crosstrees Access Tools, which are regulated as Class I exempt orthopedic manual surgical instruments.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Long Beach Memorial Medical Center | Recruiting |
Long Beach, California, United States, 90806 | |
Contact: Tina Scholte 562-424-6666 tlsmosg@yahoo.com | |
Contact: Shauna Duke 310-256-8449 | |
Principal Investigator: Philip Yuan, MD | |
United States, Maryland | |
Suburban Hospital | Recruiting |
Bethesda, Maryland, United States, 20814 | |
Contact: Jodie Stone 301-651-7587 jaugaz@aol.com | |
Principal Investigator: Wayne Olan, MD | |
United States, North Dakota | |
St. Alexius Medical Center | Recruiting |
Bismarck, North Dakota, United States, 58506 | |
Contact: Elaine Kucera 701-530-6954 ekucera@primecare.org | |
Principal Investigator: Eric Belanger, MD | |
United States, Oklahoma | |
Edmond Medical Center | Recruiting |
Oklahoma City, Oklahoma, United States, 73034 | |
Contact: Jennifer Witherby, RN 405-213-9639 jw@clinrad.org | |
Principal Investigator: Douglas Beall, MD |
Responsible Party: | Crosstrees Medical, Inc. ( Sean R. Gemmill, MS, RAC; Director of Clinical Affairs ) |
Study ID Numbers: | G080175 |
Study First Received: | July 5, 2009 |
Last Updated: | August 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00933036 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Osteoporosis VCF PVA Vertebroplasty |
Kyphoplasty Vertebral fracture Pathologic fracture Vertebral augmentation |
Musculoskeletal Diseases Fractures, Bone Wounds and Injuries Spinal Fractures Disorders of Environmental Origin |
Fractures, Spontaneous Osteoporosis Bone Diseases, Metabolic Bone Diseases |
Musculoskeletal Diseases Fractures, Bone Wounds and Injuries Disorders of Environmental Origin |
Osteoporosis Fractures, Spontaneous Bone Diseases, Metabolic Bone Diseases |