Evaluation of Fracture Fixation With Energy and Cement in Tumors of the Spine

Spinal Fractures Clinical Trial

— EFFECTS  

Official title:

Evaluation of Fracture Fixation With Energy and Cement in Tumors of the Spine

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00594321
• Other study ID #: 200715482
• Status: Withdrawn
• Phase: N/A
• First received: December 21, 2007
• Last updated: August 31, 2012
• Start date: July 2007
• Est. completion date: June 2009

Study information

• Verified date: August 2012
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Spinal Fractures

Intervention

Device:
• SPACE CpsXL Bone Cement and SPACE 360 Delivery System
SPACE CpsXL Bone Cement and SPACE 360 Delivery System
• standard vertebroplasty
standard vertebroplasty

Locations

Country	Name	City	State
United States	UC Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is cement leakage as determined radiographically (CT). will be cement leakage measured by CT.		3 years	Yes
Secondary	Secondary endpoints are reduction of pain (VAS) and quality of life measurements (Oswestry disability index).		3 years	No