Clinical Trial: Clinical Evaluation of the Crosstrees Pod™ in the Treatment of Pathologic Fracture of the Vertebral Body (Levels T4 - L5) in Adult Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical Evaluation of the Crosstrees® System for PVA in Symptomatic Adult Patients With Acute Vertebral Body Compression Fractures at T4-L5

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Crosstrees Medical Inc.

Current Primary Outcome: Clinically significant improvement in pain as measured using a 10 mm Visual Analog Scale (VAS). In this scale 0 means "no pain" and 10 is "Severe pain". A difference of at least 2 points compared to baseline is regarded as clinically relevant. [ Time Frame: Six months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Ambulatory Status/Physical Function [ Time Frame: 24 hours, 2 weeks, 1 month, 3 months, 6 months, 1 year ]
  • Quality of life [ Time Frame: 24 hours, 2 weeks, 1 month, 3 months, 6 months, 1 year ]
  • Neurological Assessment [ Time Frame: 24 hours, 2 weeks, 1 month, 3 months, 6 months, 1 year ]
  • Vertebral Body Morphology [ Time Frame: 24 hours, 2 weeks, 1 month, 3 months, 6 months, 1 year ]


Original Secondary Outcome: Same as current

Information By: Crosstrees Medical Inc.

Dates:
Date Received: July 5, 2009
Date Started: June 2009
Date Completion:
Last Updated: January 21, 2014
Last Verified: January 2014