Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant

Exclusion Criteria

• •Patient clearly improving on conservative treatment
• •Any contra-indication or allergy to implant material or cement
• •Systemic infection or infection located in the spine
• •Any medical condition including but not limited to anemia, coagulation disorders, fibromyalgia, algoneurodystrophy, Paget's disease, uncontrolled diabetes that would preclude the patient from having surgery or would impede the benefit of surgery
• •Neurologic signs or symptoms related to the fracture or the impeding pathological fracture
• •Any previous surgical treatment (material or cement) in the targeted vertebra
• •Less than one third of the original vertebral body height remaining
• •Unstable fractures or neoplasms with posterior involvement
• •Damages of the posterior wall
• •Sclerotic cancellous bone
• •Pedicles not large enough to accept V-STRUT© instrumentation and implants
• •Pregnancy(women of childbearing potential must have a negative pregnancy test to participate)
• •Pre-existing or clinically unstable neurologic deficit
• •Spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated
• •Any physical exam evidence of myelopathy or radiculopathy
• •Pain based on clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis)
• •Bedbound prior to incident fracture
• •Spondylolisthesis \>Grade 1 at target VB
• •Any underlying systemic bone disease other than osteoporosis (e.g., osteomalacia, osteogenesis imperfect, Paget's disease, etc.)
• •A medical contraindication to spinal surgery and/or general anesthesia, such as coagulopathy and/or taking warfarin (Coumadin) or other anticoagulant or anti-aggregate (anti-platelet agents) on regular basis for coagulopathy (with a threshold for normal being INR≤1.5, PTT within lab normal range, and platelet count \> 100,000)
• •Disabling backpain due to causes other than acute fracture
• •Severe cardiopulmonary deficiencies
• •Any evidence of alcohol or drug abuse
• •Uncontrolled psychiatric illness or severe dementia
• •Involved in medical litigation including workers' compensation