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ChronOS Stability Study: For Metastatic Cancer


N/A
N/A
N/A
Not Enrolling
Both
Adult Spinal Cord Neoplasm, Spinal Bone Metastases, Spinal Cord Compression

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Trial Information

ChronOS Stability Study: For Metastatic 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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Achievement of durable posterolateral fusion

Outcome Description:

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.

Outcome Time Frame:

Within 12 months

Safety Issue:

No

Principal Investigator

Thomas Chen

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California

Authority:

United States: Institutional Review Board

Study ID:

0S-09-12

NCT ID:

NCT01407341

Start Date:

June 2011

Completion Date:

June 2014

Related Keywords:

  • Adult Spinal Cord Neoplasm
  • Spinal Bone Metastases
  • Spinal Cord Compression
  • Neoplasms
  • Neoplasm Metastasis
  • Spinal Cord Compression
  • Spinal Cord Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases

Name

Location
University of Southern California Los Angeles, California  90033