CAFE Study - Cancer Patient Fracture Evaluation

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00211237
Study type	Interventional
Source	Medtronic Spinal and Biologics
Contact
Status	Completed
Phase	N/A
Start date	May 2005
Completion date	December 2009

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

CAFE Study - Cancer Patient Fracture Evaluation — CAFE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms