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

This study has been terminated.

(Lack of funding)

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

USC/Norris Comprehensive Cancer Center

ClinicalTrials.gov Identifier:

NCT01407341

First received: July 29, 2011

Last updated: August 10, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 29, 2011

Last Updated Date

August 10, 2012

Start Date ^ICMJE

June 2011

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Achievement of durable posterolateral fusion [ Time Frame: Within 12 months ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01407341 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Achievement of posterolateral fusion [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
Occurrence of subsequent hardware failure [ Time Frame: Every 3 months for 12 months ] [ Designated as safety issue: No ]
Requirement of additional treatment is for instability [ Time Frame: Within 12 months ] [ Designated as safety issue: No ]
First documentation of posterolateral fusion [ Time Frame: Within 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

ChronOS Stability Study: For Metastatic Cancer

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.

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

Adult Spinal Cord Neoplasm
Spinal Bone Metastases
Spinal Cord Compression

Intervention ^ICMJE

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
Procedure: quality-of-life assessment
Ancillary studies

Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies

Study Arm (s)

Experimental: Supportive care (ChronOS)

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

Interventions:

Procedure: musculoskeletal complications management/prevention
Procedure: bone graft
Procedure: quality-of-life assessment
Other: questionnaire administration

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Estimated Completion Date

June 2014

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01407341

Other Study ID Numbers ^ICMJE

0S-09-12, NCI-2011-01243

Has Data Monitoring Committee

Yes

Responsible Party

USC/Norris Comprehensive Cancer Center

Study Sponsor ^ICMJE

USC/Norris Comprehensive Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Thomas Chen

University of Southern California

Information Provided By

USC/Norris Comprehensive Cancer Center

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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