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Beta-Tricalcium Phosphate Bone Graft in Treating Patients Undergoing Surgery For Metastatic Spine Cancer

Primary Purpose

Adult Spinal Cord Neoplasm, Spinal Bone Metastases, Spinal Cord Compression

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
musculoskeletal complications management/prevention
bone graft
quality-of-life assessment
questionnaire administration
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Adult Spinal Cord Neoplasm

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Status-post previous fusion with allogeneic bone graft

Sites / Locations

  • University of Southern California

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (ChronOS)

Arm Description

Patients undergo placement of beta-tricalcium phosphate bone graft strips posterolaterally during surgery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Achievement of posterolateral fusion
Occurrence of subsequent hardware failure
Requirement of additional treatment is for instability
First documentation of posterolateral fusion
Occurrence of pain or disability experienced after surgery that is related to spinal metastasis or is a consequence of the resulting treatment

Full Information

First Posted
July 29, 2011
Last Updated
February 5, 2014
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01407341
Brief Title
Beta-Tricalcium Phosphate Bone Graft in Treating Patients Undergoing Surgery For Metastatic Spine Cancer
Official Title
ChronOS Stability Study: For Metastatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
June 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
OBJECTIVES: I. To determine if Chronos (beta-tricalcium phosphate bone graft) will form a posterolateral fusion mass in patients undergoing fusion surgery for spine cancer within 12 months. II. To evaluate quality of life following the use of ChronOS as measured by (a) pain (or lack of pain) associated with pseudoarthrosis and (b) the need for additional treatment for instability as a result of hardware failure. OUTLINE: Patients undergo placement of beta-tricalcium phosphate bone graft strips posterolaterally during surgery. After completion of study treatment, patients are followed up at 1 month and then every 3 months for 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Spinal Cord Neoplasm, Spinal Bone Metastases, Spinal Cord Compression

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (ChronOS)
Arm Type
Experimental
Arm Description
Patients undergo placement of beta-tricalcium phosphate bone graft strips posterolaterally during surgery.
Intervention Type
Procedure
Intervention Name(s)
musculoskeletal complications management/prevention
Other Intervention Name(s)
complications management/prevention, musculoskeletal, management/prevention, musculoskeletal complications
Intervention Description
Receive beta tricalcium-phosphate bone graft
Intervention Type
Procedure
Intervention Name(s)
bone graft
Intervention Description
Receive beta tricalcium-phosphate bone graft
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Achievement of durable posterolateral fusion
Description
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.
Time Frame
Within 12 months
Secondary Outcome Measure Information:
Title
Achievement of posterolateral fusion
Time Frame
Up to 12 months
Title
Occurrence of subsequent hardware failure
Time Frame
Every 3 months for 12 months
Title
Requirement of additional treatment is for instability
Time Frame
Within 12 months
Title
First documentation of posterolateral fusion
Time Frame
Within 12 months
Title
Occurrence of pain or disability experienced after surgery that is related to spinal metastasis or is a consequence of the resulting treatment
Time Frame
Every 3 months for 12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Status-post previous fusion with allogeneic bone graft
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Chen
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States

12. IPD Sharing Statement

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Beta-Tricalcium Phosphate Bone Graft in Treating Patients Undergoing Surgery For Metastatic Spine Cancer

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