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

This study has been terminated.
(Lack of funding)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT01407341
First received: July 29, 2011
Last updated: February 5, 2014
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Adult Spinal Cord Neoplasm
Spinal Bone Metastases
Spinal Cord Compression
Procedure: musculoskeletal complications management/prevention
Procedure: bone graft
Procedure: quality-of-life assessment
Other: questionnaire administration
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: ChronOS Stability Study: For Metastatic Cancer

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Achievement of durable posterolateral fusion [ Time Frame: Within 12 months ] [ Designated as safety issue: No ]
    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:
  • Achievement of posterolateral fusion [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Occurrence of subsequent hardware failure [ Time Frame: Every 3 months for 12 months ] [ Designated as safety issue: No ]
  • Requirement of additional treatment is for instability [ Time Frame: Within 12 months ] [ Designated as safety issue: No ]
  • First documentation of posterolateral fusion [ Time Frame: Within 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: June 2011
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supportive care (ChronOS)
Patients undergo placement of beta-tricalcium phosphate bone graft strips posterolaterally during surgery.
Procedure: musculoskeletal complications management/prevention
Receive beta tricalcium-phosphate bone graft
Other Names:
  • complications management/prevention, musculoskeletal
  • management/prevention, musculoskeletal complications
Procedure: bone graft
Receive beta tricalcium-phosphate bone graft
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407341

Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033-0804
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Thomas Chen University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01407341     History of Changes
Other Study ID Numbers: 0S-09-12, NCI-2011-01243
Study First Received: July 29, 2011
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Spinal Cord Compression
Spinal Cord Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Pathologic Processes
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Injuries
Wounds and Injuries
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014