NCT00211237

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Medtronic Spine LLC · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

1\. STUDY OBJECTIVES AND ENDPOINTS 1.1. Objectives The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, VCFs as compared to standard non-surgical therapy in patients with cancer. 1.2. Primary Endpoint The primary endpoint of the study is the improvement in functional status, as measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 month. The primary hypothesis of the study is that the mean improvement will be larger in subjects initially assigned to management with balloon kyphoplasty. Note that all subjects will undergo 12 months of follow-up after initial treatment assignment. 1.3. Secondary Endpoints The following secondary endpoints will also be examined. Comparisons will be made at each follow-up visit. Safety: * Rate of study treatment-related adverse events * Change in neurological status Clinical: * Change in functional status as assessed with Karnofsky Performance Scale * Change in quality of life as assessed by the SF-36v2™ Health Survey * Change in back pain, as measured by a 10-point Numerical Rating Scale (NRS) * Change in back-pain analgesics used * Change in ambulation status * Changes in activities of daily living * Time to treatment failure Radiographic: * Change in spinal deformity, defined as the degree of spine angulation as assessed by an independent radiologist at the core laboratory * Rate of subsequent vertebral body fractures, as assessed by independent radiologists at the core lab In each case, the study hypothesis is that treatment with balloon kyphoplasty will result in an improvement in clinical or radiographic outcomes compared to baseline and compared to non-surgical treatment, with a preservation of outcomes in long-term follow-up.

Conditions

• Cancer
• Spinal Fractures

Interventions

Type	Name	Description
DEVICE	Balloon Kyphoplasty	Ballon Kyphoplasty is a minimally invasive technique aimed at reduction of VCFs using KyphX® Inflatable Bone Tamps followed by fracture fixation with KyphX® HV-R™ Bone Cement.
OTHER	Non Surgical Management	Non-surgical treatment includes, but is not limited to, the following: back brace, pain medication, physical therapy, walking aids, bed rest, and radiation treatment.

Timeline

• Start date: 2005-05-01
• Primary completion: 2009-04-01
• Completion: 2009-12-01
• First posted: 2005-09-21
• Last updated: 2021-01-05
• Results posted: 2010-05-14

Locations

20 sites across 8 countries: United States, Australia, Belgium, Canada, Germany, Hungary, Sweden, United Kingdom