NCT01839682

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
Last Updated

April 29, 2013

Status Verified

April 1, 2013

Enrollment Period

1.9 years

First QC Date

April 10, 2013

Last Update Submit

April 25, 2013

Conditions

OsteoporosisVertebral Fracture

Keywords

StabiliTKyphoplastyVertebralCompressionFractureOsteoporosis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Assess changes in mobility.

    Enrollment, 1 month and 3 months post procedure

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients evaluated for vertebral compression fracture in clinic

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related 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. doi: 10.1007/s00198-007-0370-8. Epub 2007 Mar 27.

    PMID: 17387420BACKGROUND

  • 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. doi: 10.1097/01.brs.0000192687.07392.f1.

    PMID: 16395177BACKGROUND

MeSH Terms

Conditions

OsteoporosisSpinal FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesSpinal InjuriesBack InjuriesWounds and Injuries

Study Officials

  • Franklin G. Moser, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cedars-Sinai Medical Center

Study Record Dates

First Submitted

April 10, 2013

First Posted

April 25, 2013

Study Start

June 1, 2009

Primary Completion

May 1, 2011

Study Completion

July 1, 2011

Last Updated

April 29, 2013

Record last verified: 2013-04

Locations

US(1)