Status:
TERMINATED
OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture
Lead Sponsor:
Alphatec Spine, Inc.
Conditions:
Vertebral Compression Fractures
Eligibility:
All Genders
50-105 years
Phase:
NA
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+™ pol...
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 ex...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00961714
Start Date
August 1 2009
End Date
July 1 2013
Last Update
April 28 2022
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Scripps
La Jolla, California, United States, 92037
2
Boulder Neurosurgery Associates
Boulder, Colorado, United States, 80304
3
South Denver Neurosurgery
Littleton, Colorado, United States, 80122
4
Lyerly Neurosurgery
Jacksonville, Florida, United States, 32207