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CAFE Study - Cancer Patient Fracture Evaluation

Study:

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

Rationale:

n/a

Purpose:

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

Recruiting:
n/a

Condition Intervention Phase
Cancer
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
ClinicalTrials.gov 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

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.