Prospective Comparative Study to Compare Safety and Effectiveness of Two Vertebral Compression Fracture Reduction Techniques

Inclusion criteria

• Male or Female with at least 50 years of age
• 1 painful VCF which at least meet all following criteria:

• Fracture due to diagnosed or presumed underlying osteoporosis
• VCF between T7 and L3
• Fracture age <3 months
• VCF shows loss of height in the anterior, mid or posterior third of the VB from estimated pre-fracture configuration of at least 15% but not more than 40% based on X-Ray at baseline
• The Index fracture is acute or persistent (not healed), as demonstrated by T2 weighted STIR MRI (or bone scan if patient is contraindicated for MRI)
• Patient has failed conservative medical therapy, defined as either having a VAS back pain score of ≥50 mm at 6 weeks after initiation of fracture care or a VAS back pain score of ≥70mm at 2 weeks after initiation of fracture care
• Investigator believes target VB is suitable for SpineJack procedure and Balloon kyphoplasty (e.g., appropriate pedicle diameter) assessed on CT scan pre op
• Patient has an Oswestry Disability Index (ODI) score of ≥ 30/100
• Patient is mentally capable and willing to sign a study specific informed consent as documentation of the informed consent process prior to any study procedures
• The patient is willing and able to comply with all study requirements including follow-up visits and radiographic assessments.

Exclusion criteria

• Target VCF due to underlying or suspected tumor
• Target VCF due to high-energy trauma
• Target VCF is diagnosed as an osteonecrotic fracture
• Segmental kyphosis of target VB of >30°
• Any prior surgical treatment for a vertebral body compression fracture or other surgical procedure on target VB or adjacent level
• The patient has uncontrolled diabetes
• Pre-existing or clinically unstable neurologic deficit
• The patient has 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
• The patient has pain based on clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis)
• Patient not able to walk without assistance prior to fracture
• Any radiographic evidence of pedicle fracture visible on CT scan pre op
• 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 on regular basis for coagulopathy (with a threshold for normal being INR≤1.5, PTT within lab normal range, and platelet count > 100,000)
• Pain due to any other condition that requires daily narcotic medication
• Disabling back pain due to causes other than acute fracture
• History of intolerance or allergic reaction to titanium or acrylic compounds
• Active systemic or local infection at baseline
• Body mass index >40
• Severe cardiopulmonary deficiencies
• Any other medical illness or condition that, in the investigator's opinion, is likely to impair long-term follow-up (e.g., cancer) or greatly increase the risk of surgery including but not limited to patients with contraindications for general anesthesia (surgeon expertise)
• Any evidence of alcohol or drug abuse
• The patient has uncontrolled psychiatric illness or severe dementia
• The patient is currently on anti-cancer therapy or anti-HIV therapy
• Patient's life expectancy is less than the study duration or undergoing palliative care
• Participating in any other investigational study
• The patient is on long-term steroid therapy (steroid dose ≥ 30 mg /day for > 3 months)
• The patient is known to be involved in medical litigation including Workmen's Compensation
• Patient with contraindication for MRI
• The patient is pregnant or considering getting pregnant during study participation.