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

Phase 1

Terminated

• Conditions: Adult Spinal Cord Neoplasm; Spinal Bone Metastases; Spinal Cord Compression
• Interventions: Procedure: musculoskeletal complications management/prevention; Procedure: bone graft; Procedure: quality-of-life assessment; Other: questionnaire administration

• Registration Number: NCT01407341
• Lead Sponsor: University of Southern California

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 Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-29
• Study First Submitted QC: 2011-07-29
• Study First Posted: 2011-08-02
• Primary Completion: 2012-07
• Status Verified: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2014-02-05
• Last Update Posted: 2014-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (ChronOS)	musculoskeletal complications management/prevention	Patients undergo placement of beta-tricalcium phosphate bone graft strips posterolaterally during surgery.
Supportive care (ChronOS)	bone graft	Patients undergo placement of beta-tricalcium phosphate bone graft strips posterolaterally during surgery.
Supportive care (ChronOS)	quality-of-life assessment	Patients undergo placement of beta-tricalcium phosphate bone graft strips posterolaterally during surgery.
Supportive care (ChronOS)	questionnaire administration	Patients undergo placement of beta-tricalcium phosphate bone graft strips posterolaterally during surgery.

Primary Outcome Measures

Name	Time	Method
Achievement of durable posterolateral fusion	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States