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

Phase 1TerminatedNCT01407341

University of Southern California1 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Adult Spinal Cord Neoplasm Spinal Bone Metastases Spinal Cord Compression

Interventions

musculoskeletal complications management/preventionPROCEDURE

Receive beta tricalcium-phosphate bone graft

bone graftPROCEDURE

Receive beta tricalcium-phosphate bone graft

quality-of-life assessmentPROCEDURE

Ancillary studies

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

University of Southern California

Los Angeles, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Within 12 months

Secondary Outcomes

Achievement of posterolateral fusion

Time frame: Up to 12 months

Occurrence of subsequent hardware failure

Time frame: Every 3 months for 12 months

Requirement of additional treatment is for instability

Time frame: Within 12 months

First documentation of posterolateral fusion

Time frame: 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

Data from ClinicalTrials.gov

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