NCT00594321

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2012

Enrollment Period

1.9 years

First QC Date

December 21, 2007

Last Update Submit

August 31, 2012

Conditions

Spinal Fractures

Keywords

spinal fractures

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is cement leakage as determined radiographically (CT). will be cement leakage measured by CT.

    3 years

Secondary Outcomes (1)

  • Secondary endpoints are reduction of pain (VAS) and quality of life measurements (Oswestry disability index).

    3 years

Study Arms (2)

2

ACTIVE COMPARATOR

Subjects randomized to the control arm of the study will have a standard vertebroplasty with any FDA-approved bone cement done in accordance with the usual method employed by the treating physician.

Device: standard vertebroplasty

1

EXPERIMENTAL

Subjects randomized to the experimental arm of the study will have a vertebroplasty with the SPACE CpsXL Bone cement (FDA-approved) and SPACE 360 Delivery System (FDA-approved).

Device: SPACE CpsXL Bone Cement and SPACE 360 Delivery System

Interventions

SPACE CpsXL Bone Cement and SPACE 360 Delivery SystemDEVICE

SPACE CpsXL Bone Cement and SPACE 360 Delivery System

1
standard vertebroplastyDEVICE

standard vertebroplasty

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females between 18 and 85 years of age
  • Pain at one to three levels, or five for multiple myeloma (pain on palpation/percussion over fractured vertebral body) requiring treatment
  • Spinal metastasis (except renal cell), myeloma, or lymphoma of the spine
  • Pathological fracture(s), T5-L5, with bone marrow edema imaged by magnetic resonance imaging (MRI)
  • Visual Analog Scale (VAS) for pain of \> 4 on a scale of 0 to 10
  • Oswestry score of at least a moderate disability (21-40%)
  • 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
  • Life expectancy of \> 6 months.
  • Patient has sufficient mental capacity to comply with the protocol requirements
  • Availability for all study visits and phone calls
  • Understands the potential risks and benefits of participating in the study and is willing to provide written informed consent
  • Pathological vertebral fracture with 20-70% compression (compared to adjacent normal vertebral body)
  • Fracture age \< 6 months
  • Signal on MRI consistent with non-healed fracture
  • Female subjects must either be no longer capable of reproduction or taking acceptable measures to prevent pregnancy during the study
  • +1 more criteria

You may not qualify if:

  • Primary tumors other than plasmacytoma
  • Renal cell tumors
  • More than 80% compression of the vertebrae
  • Level(s) above T7 to treat
  • Fractures due osteoporosis
  • Burst fracture
  • Pedicle fracture
  • Neurological deficit associated with the fracture
  • Kyphosis \> 30°
  • Translation \> 4 mm
  • Instability of posterior wall with symptomatic displacement of fragment into spinal canal or significant canal compromise
  • Intercostal nerve compression
  • Active systemic or local infection at the level(s) to be treated
  • Myelopathy
  • Uncontrolled coagulopathy
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Arthur B. Dublin, M.D.

    UC Davis Dept. of Radiology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 15, 2008

Study Start

July 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

September 3, 2012

Record last verified: 2012-08

Locations

US(1)