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

February 5, 2014 updated by: University of Southern California

ChronOS Stability Study: For Metastatic Cancer

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033-0804
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supportive care (ChronOS)
Patients undergo placement of beta-tricalcium phosphate bone graft strips posterolaterally during surgery.
Other: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Names:
  • quality of life assessment
Procedure: musculoskeletal complications management/prevention
Receive beta tricalcium-phosphate bone graft
Other Names:
  • complications management/prevention, musculoskeletal
  • management/prevention, musculoskeletal complications
Procedure: bone graft
Receive beta tricalcium-phosphate bone graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of durable posterolateral fusion
Time Frame: Within 12 months
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 Outcome Measures

Outcome Measure
Time Frame
Achievement of posterolateral fusion
Time Frame: Up to 12 months
Up to 12 months
Occurrence of subsequent hardware failure
Time Frame: Every 3 months for 12 months
Every 3 months for 12 months
Requirement of additional treatment is for instability
Time Frame: Within 12 months
Within 12 months
First documentation of posterolateral fusion
Time Frame: Within 12 months
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
Time Frame: Every 3 months for 12 months
Every 3 months for 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Thomas Chen, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

July 29, 2011

First Submitted That Met QC Criteria

July 29, 2011

First Posted (Estimate)

August 2, 2011

Study Record Updates

Last Update Posted (Estimate)

February 6, 2014

Last Update Submitted That Met QC Criteria

February 5, 2014

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0S-09-12
  • NCI-2011-01243 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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