OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture

Stopped early · Not applicable

Conditions studied: Vertebral Compression Fractures

In brief

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.

Key facts

Study ID

NCT00961714

Run by

Alphatec Spine, Inc.

People needed

15

Starts

2009-08-01

Expected to finish

2013-07-01

Last updated by the study team

2022-04-28

Who can join

Age: 50 and older, up to 105. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

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.
• 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).

Where it is running

• Scripps — La Jolla, California, United States
• Boulder Neurosurgery Associates — Boulder, Colorado, United States
• South Denver Neurosurgery — Littleton, Colorado, United States
• Lyerly Neurosurgery — Jacksonville, Florida, United States
• Southwestern Orthopedic Center — Savannah, Georgia, United States
• SIU Phyysicians and Surgeons Division of Orthopaedics and Rehabilitation — Springfield, Illinois, United States
• Jewish Hospital for Advanced Medicine — Louisville, Kentucky, United States
• Clinical Radiology of Oklahoma — Edmond, Oklahoma, United States
• NeuroSpine Institute, LLC — Eugene, Oregon, United States
• Orthopaedic Associates of the Greater Lehigh Valley Easton Hospital — Easton, Pennsylvania, United States
• Neurospine Solutions, PC — Bristol, Tennessee, United States

Full record on ClinicalTrials.gov

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