Evaluation of Outcomes of DFine StabiliT Kyphoplasty in Vertebral Compression Fractures Due to Osteoporosis

April 25, 2013 updated by: Franklin G. Moser, M.D., Cedars-Sinai Medical Center

Prospective, Single Arm, Open Label Post-Market Pilot Study to Evaluate the StabiliT Vertebral Augmentation System Treat Vertebral Compression Fractures Due to Osteoporosis

This post-market surveillance research project consists of data collection at specified time points using standard questionnaire instruments to compare pain level, mobility and function pre and post procedure using the D-Fine StabiliT® Vertebral Augmentation System and StabiliT® Bone Cement, an FDA approved product used in the standard treatment of vertebral compression fractures.

Study Overview

Status

Completed

Conditions

Detailed Description

This is a single arm, post market surveillance pilot study of an FDA cleared product, to evaluate the procedural and clinical profile of an ultra high viscosity cement vertebral augmentation system for the treatment of vertebral compression vertebral fractures due to osteoporosis.

Twenty (20) consenting evaluable adult male and female patients between the ages of 50 and 90 who meet the inclusion criteria for the study and are treated using the D-Fine StabiliT® Vertebral Augmentation System and StabiliT® Bone Cement as part of their standard treatment for osteoporotic vertebral compression fractures will be enrolled in the study.

The participants will be followed after the procedure for 3 months by telephone and/or mailed questionnaire by an IRB certified member of the research team. Information collected will include the patient's ability to ambulate independently and activity level pre and post-treatment, decrease or increase in pain level compared to pre-treatment, and monitoring adverse events. Data will be collected at enrollment, procedure, discharge (or 1 day post procedure), 1 week, 1 month and 3 months post procedure using the Visual Analog Scale (VAS) for pain score, Oswestry Disability Index. Standard of care radiographs and MRI or CT/bone scan are evaluated by a board certified radiologist. The data collected will be compared to measure outcomes.

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients evaluated for vertebral compression fracture in clinic

Description

Inclusion Criteria:

  • Males and females 50-90 years of age
  • Pain on palpation/percussion over fractured vertebral body at one to three levels that require treatment
  • Compression fracture(s), T10 to L5, with bone marrow edema imaged by magnetic resonance imaging (MRI)
  • Visual Analog Scale (VAS) for pain >4 on a scale of 0-10
  • Oswestry score of at least a moderate disability (21-40%)
  • No major surgery to the spine planned for at least 1 month following enrollment
  • Life expectancy of > 6 months
  • Patient has sufficient mental capacity to comply with the protocol requirements
  • Availability for all study visits and phone calls
  • Understands the potential risks and benefits of participating in the study and is willing to provide written informed consent.
  • Vertebral compression fracture with 20-90% compression (compared to adjacent normal vertebral body)
  • Fracture age < 6 months
  • Signal on MRI or bone scan consistent with non-healed fracture
  • Female subjects must either be no longer capable of reproduction or taking acceptable measures to prevent pregnancy during the study
  • Subject must be willing and able to comply with specified follow-up evaluations

Exclusion Criteria:

  • Primary tumors and spinal metastasis, myeloma, or lymphoma of the spine
  • More than 90% compression of the vertebrae
  • Level(s) above T10
  • Pedicle fracture
  • Neurologic deficit associated with the level(s) to be treated
  • Kyphosis > 30°
  • Translation > 4 mm
  • Instability of posterior wall with symptomatic displacement of fragment into spinal canal or significant canal compromise
  • Intercostal nerve compression
  • Active systemic or local infection at the level(s) to be treated
  • Myelopathy
  • Uncontrolled coagulopathy
  • Cannot temporarily discontinue anticoagulation therapy
  • Known allergy to device materials / PMMA
  • Radiculopathy
  • Cord compression or canal compromise requiring surgery for decompression
  • Fracture due to high energy trauma
  • Severe cardiopulmonary deficiencies
  • Vertebra-plana
  • Disabling back pain secondary to another cause that may interfere with accurate data collection
  • Subjects who are known to be pregnant (pregnancy test required within10 days of treatment or lactating
  • Females capable of reproduction and will not take acceptable measures to prevent reproduction during the study
  • Currently enrolled in an investigational device (IDE) that has not completed the protocol required primary follow-up period (excludes 15 year follow-up of gene therapy trials)
  • Lesions involving the pedicle

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure changes in pain
Time Frame: Enrollment, discharge (or 1 day), 1 week, 1 month, 3 month post procedure
Pain will be assessed using the Visual Assessment Scale (VAS) at enrollment, and interval changes captured at discharge (or 1 day), 1 week, 1 month and 3 months post procedure. Pre and post procedure pain will be compared.
Enrollment, discharge (or 1 day), 1 week, 1 month, 3 month post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess changes in mobility.
Time Frame: Enrollment, 1 month and 3 months post procedure
Assess changes in mobility using the Oswestry Disability Index pre to capture interval changes at enrollment, and at 1 month and 3 months post procedure.
Enrollment, 1 month and 3 months post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Collaborators

DFINE Inc.

Investigators

  • Principal Investigator: Franklin G. Moser, MD, Cedars-Sinai Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

April 10, 2013

First Submitted That Met QC Criteria

April 24, 2013

First Posted (Estimate)

April 25, 2013

Study Record Updates

Last Update Posted (Estimate)

April 29, 2013

Last Update Submitted That Met QC Criteria

April 25, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Siegel-1
  • 00017253 (Other Identifier: Cedars-Sinai Medical Center IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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