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

NCT ID: NCT01407341

Last Updated: 2014-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Adult Spinal Cord Neoplasm Spinal Bone Metastases Spinal Cord Compression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive care (ChronOS)

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

Group Type EXPERIMENTAL

musculoskeletal complications management/prevention

Intervention Type PROCEDURE

Receive beta tricalcium-phosphate bone graft

bone graft

Intervention Type PROCEDURE

Receive beta tricalcium-phosphate bone graft

quality-of-life assessment

Intervention Type PROCEDURE

Ancillary studies

questionnaire administration

Intervention Type OTHER

Ancillary studies

Interventions

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musculoskeletal complications management/prevention

Receive beta tricalcium-phosphate bone graft

Intervention Type PROCEDURE

bone graft

Receive beta tricalcium-phosphate bone graft

Intervention Type PROCEDURE

quality-of-life assessment

Ancillary studies

Intervention Type PROCEDURE

questionnaire administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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complications management/prevention, musculoskeletal management/prevention, musculoskeletal complications quality of life assessment

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Chen

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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University of Southern California

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2011-01243

Identifier Type: REGISTRY

Identifier Source: secondary_id

0S-09-12

Identifier Type: -

Identifier Source: org_study_id

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