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

Study Overview
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Brief Summary
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The purpose of this study is to compare the safety and effectiveness of the SpineJack® with the Kyphx Xpander® Inflatable Bone Tamp and support a non-inferiority finding for the use of SpineJack® VCF treatment system versus Balloon Kyphoplasty.

Official Title
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A Prospective, Multicenter, Randomized, Comparative Clinical Study to Compare the Safety and Effectiveness of Two Vertebral Compression Fracture (VCF) Reduction Techniques: the SpineJack® and the KyphX Xpander® Inflatable Bone Tamp

Conditions
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Spinal Fractures, Vertebral Compression Fractures, Back Injuries, Osteoporosis

Intervention / Treatment
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* Device: Vertebral fracture surgery SpineJack®
* Procedure: Balloon Kyphoplasty


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SpineJack® system<br>VCF treatment system Vertebral fracture surgery | Device: Vertebral fracture surgery SpineJack®<br>* Vertebral augmentation for one osteoporotic vertebral compression fracture<br>|
| Active Comparator: Balloon Kyphoplasty<br>VCF treatment system Vertebral fracture surgery | Procedure: Balloon Kyphoplasty<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants With Study Success | The primary composite endpoint defines a successful subject if the following components are satisfied (safety and effectiveness): Reduction in VCF fracture-related pain at 12 months from baseline as measured by a 100 mm VAS scale (reduction of pain at 12 months by > 20 mm) AND, Maintenance or improvement in function at 12 months from baseline as measured by the 100 point Oswestry Disability Index (ODI) AND, Absence of device-related serious adverse events, defined as device-related adverse events (device migration, recollapse, protrusion) or symptomatic cement extravasation requiring surgical re-intervention or retreatment at the index level, including revision, removal, reoperation, and/or supplemental fixation. | 12 month post-op |