Spinal Fractures
Conditions
Keywords
spinal fractures
Brief summary
The objective of the clinical trial is to evaluate the SPACE 360 Delivery System using SPACE CpsXL Bone Cement compared to standard vertebroplasty in the treatment of pathological fractures of the spine caused by metastatic tumors of the spine, myeloma, or lymphoma. Up to a total of three levels per patient may be included or five levels for multiple myeloma. The control group will be standard vertebroplasty.
Detailed description
The primary endpoint is cement leakage as determined radiographically (CT). will be cement leakage measured by CT. Secondary endpoints are reduction of pain (VAS) and quality of life measurements (Oswestry disability index).
Interventions
DEVICESPACE CpsXL Bone Cement and SPACE 360 Delivery System
SPACE CpsXL Bone Cement and SPACE 360 Delivery System
DEVICEstandard vertebroplasty
standard vertebroplasty
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females between 18 and 85 years of age 2. Pain at one to three levels, or five for multiple myeloma (pain on palpation/percussion over fractured vertebral body) requiring treatment 3. Spinal metastasis (except renal cell), myeloma, or lymphoma of the spine 4. Pathological fracture(s), T5-L5, with bone marrow edema imaged by magnetic resonance imaging (MRI) 5. Visual Analog Scale (VAS) for pain of \> 4 on a scale of 0 to 10 6. Oswestry score of at least a moderate disability (21-40%) 7. No major surgery to the spine planned for at least 1 month following enrollment - Defined as a procedure the magnitude of a laminectomy or more 8. Life expectancy of \> 6 months. 9. Patient has sufficient mental capacity to comply with the protocol requirements 10. Availability for all study visits and phone calls 11. Understands the potential risks and benefits of participating in the study and is willing to provide written informed consent 12. Pathological vertebral fracture with 20-70% compression (compared to adjacent normal vertebral body) 13. Fracture age \< 6 months 14. Signal on MRI consistent with non-healed fracture 15. Female subjects must either be no longer capable of reproduction or taking acceptable measures to prevent pregnancy during the study 16. Subject must be willing and able to comply with specified follow-up evaluations
Exclusion criteria
1. Primary tumors other than plasmacytoma 2. Renal cell tumors 3. More than 80% compression of the vertebrae 4. Level(s) above T7 to treat 5. Fractures due osteoporosis 6. Burst fracture 7. Pedicle fracture 8. Neurological deficit associated with the fracture 9. Kyphosis \> 30° 10. Translation \> 4 mm 11. Instability of posterior wall with symptomatic displacement of fragment into spinal canal or significant canal compromise 12. Intercostal nerve compression 13. Active systemic or local infection at the level(s) to be treated 14. Myelopathy 15. Uncontrolled coagulopathy 16. Cannot temporarily discontinue anticoagulation therapy 17. Known allergy to device materials / PMMA 18. Radiculopathy 19. Cord compression or canal compromise requiring surgery for decompression 20. High energy trauma 21. Severe cardiopulmonary deficiencies - Defined as not being able to tolerate general anesthesia (although the likelihood is local anesthesia will be used) 22. Vertebra plana defined as vertebral body height of 20% or less compared to the nearest normal level 23. Disabling back pain secondary to another cause that may interfere with accurate data collection 24. Subjects who are known to be pregnant (pregnancy test required within 10 days of treatment) or lactating 25. Females capable of reproduction and will not take acceptable measures to prevent reproduction during the study 26. Subjects who test positive for HIV 27. Currently enrolled in another investigational device trial (IDE) that has not completed the protocol required primary follow-up period (excludes 15 year follow-up of gene therapy trials) 28. Lesions involving the pedicle 29. Platelet count of \< 50,000
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is cement leakage as determined radiographically (CT). will be cement leakage measured by CT. | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are reduction of pain (VAS) and quality of life measurements (Oswestry disability index). | 3 years |
Countries
United States
Outcome results
None listed