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CAFE Study - Cancer Patient Fracture Evaluation


A Multicenter, Prospective, Randomized, Controlled Study to Compare Balloon Kyphoplasty to Non-surgical Fracture Management in the Treatment of Painful, Acute Vertebral Body Compression Fractures in Cancer Patients




The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, vertebral compression fractures (VCFs) as compared to standard non-surgical therapy in patients with cancer.

Study Status: Completed


Condition Intervention Phase
Spinal Fractures
Device: Balloon Kyphoplasty
Other: Non Surgical Management
Phase 4

Verified by Medtronic Spine LLC May, 2010

Sponsored by: Medtronic Spine LLC
Information provided by: Medtronic Spine LLC identifier: NCT00211237

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic
Cleveland, Ohio 44195
United States

James Berenson, M.D.., Principal Investigator
Frank Vrionis, M.D.., Principal Investigator

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