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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839682
• Other study ID #: Siegel-1
• Secondary ID: 00017253
• Status: Completed
• Phase: N/A
• First received: April 10, 2013
• Last updated: April 25, 2013
• Start date: June 2009
• Est. completion date: July 2011

Study information

• Verified date: April 2013
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Compression
• Osteoporosis
• Osteoporotic Fractures
• Spinal Fractures
• Vertebral Fracture

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	DFINE Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Chin DK, Park JY, Yoon YS, Kuh SU, Jin BH, Kim KS, Cho YE. Prevalence of osteoporosis in patients requiring spine surgery: incidence and significance of osteoporosis in spine disease. Osteoporos Int. 2007 Sep;18(9):1219-24. Epub 2007 Mar 27. — View Citation

Ledlie JT, Renfro MB. Kyphoplasty treatment of vertebral fractures: 2-year outcomes show sustained benefits. Spine (Phila Pa 1976). 2006 Jan 1;31(1):57-64. Erratum in: Spine. 2006 Jun 15;31(14):1635. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure changes in pain	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	No
Secondary	Assess changes in mobility.	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	No