Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial

• Sponsor: University of Virginia (Other)
• Overall Status: Completed
• CT.gov ID: NCT00279877
• Collaborator: Cardinal Health (Industry), ArthroCare Corporation (Other), Cook Group Incorporated (Industry)
• Enrollment: 112
• Location: 1
• Arms: 2
• Duration (Months): 76
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

Randomized trial comparing cost effectiveness and efficacy of kyphoplasty vs vertebroplasty for the treatment of painful, osteoporotic vertebral compression fractures.

Condition or Disease	Intervention/Treatment	Phase
Osteoporotic Vertebral Compression Fractures	Procedure: Kyphoplasty	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Cost Effectiveness and Efficacy of Kypho and Vertebro Plasty Trial
• Study Start Date: May 1, 2005
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: vertebroplasty vertebroplasty	Procedure: Kyphoplasty; kyphoplasty
Active Comparator: kyphoplasty kyphoplasty	Procedure: Kyphoplasty; kyphoplasty

Outcome Measures

Primary Outcome Measures

1. Back specific functional status(Roland) [12 mo]

2. Pain [12 mo]

Secondary Outcome Measures

1. Health status outcome measure(SF-36) [12 mo]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

• or = 50 years of age

• Compression fracture (T4-L5)within previous 12 mo.

• Pain from compression fracture

• No malignant tumor

• No back surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Virginia	Charlottesville	Virginia	United States	22908

Sponsors and Collaborators

• University of Virginia
• Cardinal Health
• ArthroCare Corporation
• Cook Group Incorporated

Investigators

• Principal Investigator: Avery Evans, M.D., University of Virginia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Avery Evans, MD, MD, University of Virginia
• ClinicalTrials.gov Identifier: NCT00279877
• Other Study ID Numbers: 12031
• First Posted: Jan 20, 2006
• Last Update Posted: Aug 18, 2016
• Last Verified: Aug 1, 2016

• Additional relevant MeSH terms: Fractures, Compression

Study Results

No Results Posted as of Aug 18, 2016