NCT01407341

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

ChronOS Stability Study: For Metastatic Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Adult Spinal Cord Neoplasm
• Spinal Bone Metastases
• Spinal Cord Compression

Interventions

Type	Name	Description
PROCEDURE	musculoskeletal complications management/prevention	Receive beta tricalcium-phosphate bone graft
PROCEDURE	bone graft	Receive beta tricalcium-phosphate bone graft
PROCEDURE	quality-of-life assessment	Ancillary studies
OTHER	questionnaire administration	Ancillary studies

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-07-01
• Completion: 2012-08-01
• First posted: 2011-08-02
• Last updated: 2014-02-06

Locations

1 site across 1 country: United States