OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture

NCT00961714 | Terminated Results DMC

• 1 other identifier: 08-02-A
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Vertebral Compression Fractures

Keywords

VCF

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Back Pain Improvement at 12 Months

  Back pain improvement is defined as a reduction in VAS score of ≥ 20mm at 12 months from baseline

  12 months

• Percentage of Participants With Functional Disability Improvement at 12 Months

  Functional disability improvement is defined as a reduction in ODI score by ≥ 15 points at 12 months from baseline.

  12 months

• Absence of Device Related Subsequent Interventions or Re-treatment at the Study Treated Levels

  12 months

Secondary Outcomes (3)

• Change in Pain at 12 Months as Presented by VAS, When Compared to Baseline

  12 months

• Functional Disability Change at 12months From Baseline as Determined by ODI

  12 months

• Any Cement Extravasation Before Discharge

  12 months

Study Arms (1)

OsseoFix

EXPERIMENTAL

Osseofix is an titanium expandable device similar to a vascular stent that is placed in the fractured vertebral body to provide a structure in which bone cement (polymethylmethacrylate) is inserted. It is intended to be used in the thoracolumbar spine between levels T6 through L5.

Device: OsseoFix Spinal Fracture Reduction System

Interventions

OsseoFix Spinal Fracture Reduction System DEVICE

All enrolled into the study will be receiving the OsseoFix if meet inclusion / exclusion criteria.

OsseoFix

Eligibility Criteria

• Age: 50 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• o 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alphatec Spine, Inc.: lead

Study Sites (11)

Scripps

La Jolla, California, 92037, United States

Location

Boulder Neurosurgery Associates

Boulder, Colorado, 80304, United States

Location

South Denver Neurosurgery

Littleton, Colorado, 80122, United States

Location

Lyerly Neurosurgery

Jacksonville, Florida, 32207, United States

Location

Southwestern Orthopedic Center

Savannah, Georgia, 31405, United States

Location

SIU Phyysicians and Surgeons Division of Orthopaedics and Rehabilitation

Springfield, Illinois, 62702, United States

Location

Jewish Hospital for Advanced Medicine

Louisville, Kentucky, 40202, United States

Location

Clinical Radiology of Oklahoma

Edmond, Oklahoma, 73034, United States

Location

NeuroSpine Institute, LLC

Eugene, Oregon, 97401, United States

Location

Orthopaedic Associates of the Greater Lehigh Valley Easton Hospital

Easton, Pennsylvania, 18045, United States

Location

Neurospine Solutions, PC

Bristol, Tennessee, 37620, United States

Location

Results Point of Contact

• Title: Glen Seidner, Clinical Affairs
• Organization: Alphatec Spine, Inc.

gseidner@alphatecspine.com

760-494-6789

Study Officials

• James Yue, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Daniel Bennett, MD

  Integrative Treatment Centers

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2009
• First Posted: August 19, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: July 1, 2013
• Last Updated: April 28, 2022
• Results First Posted: April 4, 2022

Record last verified: 2022-04

Locations

US (11)