Spinal Fractures, Vertebral Compression Fractures, Back Injuries, Osteoporosis
Conditions
Brief summary
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.
Interventions
DEVICEVertebral fracture surgery SpineJack®
Vertebral augmentation for one osteoporotic vertebral compression fracture
PROCEDUREBalloon Kyphoplasty
Sponsors
ACES Ing.-GmbH
Vexim SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or Female with at least 50 years of age 2. 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) 3. 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 4. Investigator believes target VB is suitable for SpineJack procedure and Balloon kyphoplasty (e.g., appropriate pedicle diameter) assessed on CT scan pre op 5. Patient has an Oswestry Disability Index (ODI) score of ≥ 30/100 6. 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 7. The patient is willing and able to comply with all study requirements including follow-up visits and radiographic assessments.
Exclusion criteria
1. Target VCF due to underlying or suspected tumor 2. Target VCF due to high-energy trauma 3. Target VCF is diagnosed as an osteonecrotic fracture 4. Segmental kyphosis of target VB of \>30° 5. Any prior surgical treatment for a vertebral body compression fracture or other surgical procedure on target VB or adjacent level 6. The patient has uncontrolled diabetes 7. Pre-existing or clinically unstable neurologic deficit 8. The patient has spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated 9. Any physical exam evidence of myelopathy or radiculopathy 10. The patient has pain based on clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis) 11. Patient not able to walk without assistance prior to fracture 12. Any radiographic evidence of pedicle fracture visible on CT scan pre op 13. Spondylolisthesis \>Grade 1 at target VB 14. Any underlying systemic bone disease other than osteoporosis (e.g., osteomalacia, osteogenesis imperfect, Paget's disease, etc.) 15. 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) 16. Pain due to any other condition that requires daily narcotic medication 17. Disabling back pain due to causes other than acute fracture 18. History of intolerance or allergic reaction to titanium or acrylic compounds 19. Active systemic or local infection at baseline 20. Body mass index \>40 21. Severe cardiopulmonary deficiencies 22. 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) 23. Any evidence of alcohol or drug abuse 24. The patient has uncontrolled psychiatric illness or severe dementia 25. The patient is currently on anti-cancer therapy or anti-HIV therapy 26. Patient's life expectancy is less than the study duration or undergoing palliative care 27. Participating in any other investigational study 28. The patient is on long-term steroid therapy (steroid dose ≥ 30 mg /day for \> 3 months) 29. The patient is known to be involved in medical litigation including Workmen's Compensation 30. Patient with contraindication for MRI 31. The patient is pregnant or considering getting pregnant during study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Study Success | 12 month post-op | The primary composite endpoint defines a successful subject if the following components are satisfied (safety and effectiveness): 1. 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, 2. Maintenance or improvement in function at 12 months from baseline as measured by the 100 point Oswestry Disability Index (ODI) AND, 3. 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. |
Countries
France, Germany, Italy, Spain, Switzerland
Outcome results
None listed