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

Spinal Cord Compression Clinical Trial

Official title:

ChronOS Stability Study: For Metastatic Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01407341
• Other study ID #: 0S-09-12
• Secondary ID: NCI-2011-01243
• Status: Terminated
• Phase: Phase 1
• First received: July 29, 2011
• Last updated: February 5, 2014
• Start date: June 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• musculoskeletal complications management/prevention
Receive beta tricalcium-phosphate bone graft
• bone graft
Receive beta tricalcium-phosphate bone graft
• quality-of-life assessment
Ancillary studies

Other:
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 12 months	No
Secondary	Achievement of posterolateral fusion		Up to 12 months	No
Secondary	Occurrence of subsequent hardware failure		Every 3 months for 12 months	No
Secondary	Requirement of additional treatment is for instability		Within 12 months	No
Secondary	First documentation of posterolateral fusion		Within 12 months	No
Secondary	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	No