Study Stopped
Lack of funding
Beta-Tricalcium Phosphate Bone Graft in Treating Patients Undergoing Surgery For Metastatic Spine Cancer
ChronOS Stability Study: For Metastatic Cancer
2 other identifiers
interventional
1
1 country
1
Brief Summary
This pilot clinical trial studies beta-tricalcium phosphate bone graft in treating patients undergoing surgery for metastatic spine cancer. A bone graft may help healing and bone growth in patients undergoing surgery for spine cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 29, 2011
CompletedFirst Posted
Study publicly available on registry
August 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFebruary 6, 2014
August 1, 2012
1.1 years
July 29, 2011
February 5, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Achievement of durable posterolateral fusion
Measured from x-ray and/or computed tomography (CT) scans. Standard criteria of determining fusion is visualization of continuous trabeculating bone bridging the transverse processes and facets on AP and lateral x-rays or when there is \< 2 degree angular motion and \< 2mm of translation on standing flexion and extension radiographs.
Within 12 months
Secondary Outcomes (5)
Achievement of posterolateral fusion
Up to 12 months
Occurrence of subsequent hardware failure
Every 3 months for 12 months
Requirement of additional treatment is for instability
Within 12 months
First documentation of posterolateral fusion
Within 12 months
Occurrence of pain or disability experienced after surgery that is related to spinal metastasis or is a consequence of the resulting treatment
Every 3 months for 12 months
Study Arms (1)
Supportive care (ChronOS)
EXPERIMENTALPatients undergo placement of beta-tricalcium phosphate bone graft strips posterolaterally during surgery.
Interventions
Receive beta tricalcium-phosphate bone graft
Ancillary studies
Eligibility Criteria
You may qualify if:
- All patients undergoing surgery for spinal decompression for tatic spine cancer who require bone substitute for a posterolateral spinal fusion
- Patients may or may not have posterolateral instrumentation
You may not qualify if:
- Status-post previous fusion with allogeneic bone graft
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Californialead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Southern California
Los Angeles, California, 90033-0804, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Chen
University of Southern California
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2011
First Posted
August 2, 2011
Study Start
June 1, 2011
Primary Completion
July 1, 2012
Study Completion
August 1, 2012
Last Updated
February 6, 2014
Record last verified: 2012-08