Crosstrees Medical Clinical Trial to Evaluate the Performance of Crosstrees™ System in Reducing Pain and Decreasing the Risk of Cement Leakage in Vertebral Compression Fractures
Who May Be a Candidate
To be considered for this pilot study, male or female subjects must be 50 years or older and meet other eligibility criteria. Candidates must have a fracture due to osteoporosis. Only a clinical trial research team member or investigator can determine if you are eligible for this research study. To find out if you qualify email clinicaltrial@crosstreesmedical.com
Product Being Studied
The Crosstrees™ System clinical trial is being conducted to evaluate the performance of the Crosstrees System in reducing pain and decreasing the risk of cement leakage in the treatment of vertebral compression fractures (VCF). The procedure is minimally invasive (small skin incision). The Crosstrees System uses a fabric Pod that allows the physician to control the flow of bone cement as it is injected into the vertebral body. Crosstrees Fortibrae PMMA (polymethylmethacrylate) is the bone filler material used.
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To find out if you qualify to participate in this clinical study, email clinicaltrial@crosstreesmedical.com
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Figure 1: The Crosstrees System uses a fabric Pod that allows the physician to control the flow of bone cement as it is injected into the vertebral body.
Figure 2: The system is designed to allow Pod removal, thereby eliminating the need for a permanent implant to remain within the patient.
Click for a brief animation of the Crosstrees™ System
Clinical Trial Sponsor
Crosstrees Medical, Inc.
Purpose and Objective
The clinical trial is being conducted to evaluate the performance of the Crosstrees System for Percutaneous Vertebral Augmentation (PVA )in reducing pain and decreasing the risk of cement leakage associated with vertebroplasty and kyphoplasty.
Recruiting Locations (United States)
Please include what state you live in so we can quickly route you to a clinical trial site in your area.
Eligibility, Inclusion and Exclusion Criteria
Ages Eligible for Study: 50 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
ClinicalTrials.gov Identifier: NCT00933036
Study ID Numbers: G080175
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™ System for Percutaneous Vertebral Augmentation in the Treatment of Pathologic Fracture of the Vertebral Body (Levels T4 - L5) in Adult Patients
