OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture

This study has been terminated.
(Withdrew study)
Sponsor:
Information provided by (Responsible Party):
Alphatec Spine, Inc.
ClinicalTrials.gov Identifier:
NCT00961714
First received: August 17, 2009
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

The OsseoFix Spinal Fracture Reduction System facilitates the treatment of spinal fractures by providing internal fixation and stabilization using a titanium implant in conjunction with OsseoFix+™ polymethylmethacrylate (PMMA) bone cement.

The purpose of the study is to provide reasonable assurance on safety and effectiveness of the OsseoFix Spinal Fracture Reduction System for market release approval in the US.

This investigational device is intended to restore biomechanical integrity to a vertebral body that has suffered a painful compression fracture in the thoracic or lumbar spine between levels T6 and L5.


Condition Intervention Phase
Vertebral Compression Fractures
Device: OsseoFix Spinal Fracture Reduction System
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Effectiveness of the OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture

Resource links provided by NLM:


Further study details as provided by Alphatec Spine, Inc.:

Primary Outcome Measures:
  • Reduction of back pain at 12-m f/u by ≥ 20mm from baseline measured by VAS [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Reduction in functional disability at 12m f/u by ≥ 15 pnts from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • No device related surgical intervention/retreatment at treated level during 12m [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change VAS at 12m [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change ODI at 12m [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of subject free device related surgical intervention during 12m [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Any cement extravasation before discharge [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Any new VCF during 12m [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change neuro status at 12m f/u [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Vertical height and spine alignment by x-ray at 12m f/u [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • QOL improvement [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: August 2009
Study Completion Date: July 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OsseoFix Device: OsseoFix Spinal Fracture Reduction System
All enrolled into the study will be receiving the OsseoFix if meet inclusion / exclusion criteria.

Detailed Description:

This is a prospective, multi-center clinical study designed to evaluate safety and effectiveness of the OsseoFix Spinal Fracture Reduction System used with PMMA bone cement relative to the clinical expectations for treatment of vertebral compression fractures (VCFs). The study will be conducted at up to 15 investigational centers in the United States in 115 (up to 125) subjects with one or two vertebral compression fractures between levels T6 and L5 implanted with the investigational device(s).

Baseline screening will be completed to determine eligible subjects. VCFs will be confirmed by magnetic resonance imaging (MRI), or by a CT / bone scan. These diagnostic tests will be utilized to confirm that there are no retropulsed bone fragments. Subjects who meet all inclusion criteria and do not have any exclusion criteria will be scheduled to receive the OsseoFix Spinal Fracture Reduction System.

Subjects that are enrolled will be implanted with the OsseoFix Spinal Fracture Reduction System through a postero-lateral approach to the anterior vertebral body using instruments specifically designed for this procedure.

Radiographs will be taken at each follow-up visit, including baseline and post-operatively. Subject's perception of pain will be assessed using the Visual Analogue Scale (VAS). Functional outcomes will be measured using the Oswestry Disability Index (ODI) and Short Form- 36 (SF-36) questionnaires as well as their neurologic status. The VAS, ODI, SF-36 and neurologic status will be measured at baseline, 4-week, 3-month, 6-month and 12-month follow-up visits. Overall patient-satisfaction will be evaluated at all post-implant scheduled follow-up visits. Adverse event will be the recorded in all scheduled and non-scheduled visits.

The endpoint analysis will be performed and submitted when all implanted subjects have completed their 12-months follow-up.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 5o years of age.
  • Legal US citizen with ability to read and write.
  • Acute painful fracture (≤2 months) between T6 to L5 as evidenced by plain radiography, CT / Bone scan, and/or magnetic resonance imaging.
  • Subject is...

    • Non-Standard Treatment:

      • Inability to tolerate prolonged conservative care due to intractable pain (VAS 70/100) with maximum tolerated medication for at least 2 weeks, but less than 6 weeks; OR
      • Inability to tolerate prolonged immobilization due to other comorbid conditions aggravated by immobility for at least 2 weeks, but less than 6 weeks; OR
      • Intolerance of or adverse reaction to available pain medications for at least 2 weeks, but less than 6 weeks; OR
      • Hospitalization secondary to pain for at least 2 weeks, but less than 6 weeks.
    • Standard Treatment:

      • Has undergone at least 6 weeks of conservative care.
  • Have a self assessment VAS score ≥ 50 mm at the Baseline visit.
  • Have 30% or greater disability score on ODI at the Baseline visit.
  • Anterior wedge deformity with no less than 5% and no more than 75% loss of anterior cortical height as compared to the posterior cortical height of the same vertebral body.
  • Bone mineral density (BMD) T-score of -1.5 or less, as determined by a DEXA scan.
  • Intact posterior cortical vertebral body wall.
  • Type A compression fractures according to AO classification of spinal vertebral fractures.
  • If a transpedicular approach is utilized the pedicle diameter must be equal to or greater than 6.5 mm; however, if an extrapedicular approach is utilized there is not a minimum pedicle width requirement.
  • Subject is willing and able to provide informed consent and agrees to release medical information for purposes of this study (HIPAA authorization) and to return for scheduled follow-up evaluations.

Exclusion Criteria:

  • Significant vertebral collapse defined as more than 75% of original vertebral height or less than 5% or a burst or pedicle fracture with posterior cortical wall disruption.
  • Presence of healed fracture at the intended treatment level(s) based on a CT / bone scan or MRI.
  • Compression fractures requiring treatment at 3 or more levels.
  • Spinal/Foraminal canal compromised.
  • Significant deformity/instability indicated by:

    • Segmental kyphosis > 30 degrees, or
    • translation > 4 mm.
  • VAS back pain score of < 50 mm.
  • ODI score of < 30%.
  • Have a documented active systemic or local infection, such as AIDS, hepatitis, with a WBC greater than 11.5 and a temperature greater than 101.5°F.
  • Spinal surgery in the thoracic and/or lumbar region within the past year
  • Previous kyphoplasty or vertebroplasty at involved level or level above or below treated level.
  • Spinal arthrodesis within 2 adjacent levels of fracture.
  • Non-ambulatory prior to fracture.
  • Greater than Grade 1 spondylolisthesis at level of fracture.
  • Scoliosis > 10 degrees.
  • BMI > 40.
  • Severe cardiopulmonary deficiencies.
  • Pregnant.
  • Type I or II diabetes without controlled A1C level.
  • Achondrogenesis disorders.
  • Active malignancy, hemangiomas at the operative level(s), or multiple myeloma.
  • No generally accepted medical contraindication to spinal surgery and/or general anesthesia, such as coagulopathy with a threshold for INR at 1.5 or less, and platelet count 100,000.
  • A life expectancy less than the study duration or undergoing palliative care.
  • Trauma injuries aside from vertebral compression fracture(s).
  • Injuries that violate the posterior vertebral cortex and/or posterior column.
  • Active litigation.
  • Currently on workman's compensation.
  • Autoimmune disorders.
  • Non-spine pain that requires daily Opioids.
  • Systemic long-term steroid use - greater than 6 months.
  • Active multiple sclerosis or neurologic deficit caudal to fracture.
  • Currently an alcohol, solvent, or drug abuser.
  • Psychiatric or cognitive impairment that, in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements.
  • History of allergies to any of the device components including but not limited to commercially pure titanium, titanium alloy, polymethylmethacrylate or Zirconium Oxide (ZrO2)
  • Incarcerated.
  • Are currently participating in another investigational study.
  • Having had another device implanted in the thoracic and/or lumbar area that would interfere with the surgical approach, study device, or follow-up evaluations.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961714

Locations
United States, California
Scripps
La Jolla, California, United States, 92037
United States, Colorado
Boulder Neurosurgery Associates
Boulder, Colorado, United States, 80304
South Denver Neurosurgery
Littleton, Colorado, United States, 80122
United States, Florida
Lyerly Neurosurgery
Jacksonville, Florida, United States, 32207
United States, Georgia
Southwestern Orthopedic Center
Savannah, Georgia, United States, 31405
United States, Illinois
SIU Phyysicians and Surgeons Division of Orthopaedics and Rehabilitation
Springfield, Illinois, United States, 62702
United States, Kentucky
Jewish Hospital for Advanced Medicine
Louisville, Kentucky, United States, 40202
United States, Oklahoma
Clinical Radiology of Oklahoma
Edmond, Oklahoma, United States, 73034
United States, Oregon
NeuroSpine Institute, LLC
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Orthopaedic Associates of the Greater Lehigh Valley Easton Hospital
Easton, Pennsylvania, United States, 18045
United States, Tennessee
Neurospine Solutions, PC
Bristol, Tennessee, United States, 37620
Sponsors and Collaborators
Alphatec Spine, Inc.
Investigators
Principal Investigator: James Yue, MD Yale University
Principal Investigator: Daniel Bennett, MD Integrative Treatment Centers
  More Information

Additional Information:
No publications provided

Responsible Party: Alphatec Spine, Inc.
ClinicalTrials.gov Identifier: NCT00961714     History of Changes
Other Study ID Numbers: 08-02-A
Study First Received: August 17, 2009
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Alphatec Spine, Inc.:
VCF

Additional relevant MeSH terms:
Fractures, Bone
Spinal Fractures
Fractures, Compression
Wounds and Injuries
Spinal Injuries
Back Injuries

ClinicalTrials.gov processed this record on August 28, 2014