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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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
University of Southern California
United States: Institutional Review Board
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