NCT01871519

Evaluation of Outcomes for Quality of Life and Activities of Daily Living for BKP in the Treatment of VCFs

A Prospective and Multicenter Evaluation of Outcomes for Quality of Life and Activities of Daily Living for Balloon Kyphoplasty in the Treatment of Vertebral Compression Fractures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 354 (actual)
• Sponsor: Medtronic Spinal and Biologics · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The study objective is to collect and report 12-month outcomes pertaining to activities of daily living, quality of life, and safety parameters in a Medicare population to be treated with balloon kyphoplasty in the treatment of painful, acute, vertebral body compression fractures (VCFs) associated with either osteoporosis or cancer. The primary objective is to show statistically significant improvement from baseline in the four co-primary endpoints (SF-36v2, PCS, EQ-5D, NRS back pain and ODI) at 3-months; study success will be declared if the primary objective is met. New radiographic fractures, non-surgical management received, VCF-related healthcare resource utilization, and vertebral body height restoration data will also be collected.

Conditions

• Compression Fracture of Vertebral Body
• Osteoporosis
• Cancer

Interventions

Type	Name	Description
DEVICE	Balloon kyphoplasty	The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-12-01
• Completion: 2016-05-01
• First posted: 2013-06-06
• Last updated: 2017-03-29
• Results posted: 2017-02-07

Locations

25 sites across 1 country: United States