Cost Effectiveness and Efficacy of Kyphoplasty and Verteb... | NCT00279877

Studies
Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial

NCT00279877

Sponsor

University of Virginia

Status

Completed

Last Update Posted

Aug 18, 2016Estimated

Enrollment

112Actual

Phase

Phase 3

Conditions

Osteoporotic Vertebral Compression Fractures

Interventions

Kyphoplasty

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Jan 18, 2006

First Submission Date that Met QC Criteria

Jan 18, 2006

First Posted Date

Jan 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2016

Last Update Posted Date

Aug 18, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Avery Evans, MD, MD, University of VirginiaPrincipal Investigator

Lead Sponsor

University of VirginiaOTHER

Collaborators

Name	Class
Cardinal Health	INDUSTRY
ArthroCare Corporation	OTHER
Cook Group Incorporated	INDUSTRY

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

112Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vertebroplasty	Active Comparator	vertebroplasty	Procedure: Kyphoplasty
kyphoplasty	Active Comparator	kyphoplasty	Procedure: Kyphoplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Kyphoplasty	Procedure	kyphoplasty	kyphoplasty vertebroplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Back specific functional status(Roland)		12 mo
Pain		12 mo

Secondary Outcomes

Measure	Description	Time Frame
Health status outcome measure(SF-36)		12 mo

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

> or = 50 years of age
Compression fracture (T4-L5)within previous 12 mo.
Pain from compression fracture
No malignant tumor
No back surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Avery Evans, M.D.	University of Virginia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Virginia		Charlottesville	Virginia	22908	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26109687	Derived	Evans AJ, Kip KE, Brinjikji W, Layton KF, Jensen ML, Gaughen JR, Kallmes DF. Randomized controlled trial of vertebroplasty versus kyphoplasty in the treatment of vertebral compression fractures. J Neurointerv Surg. 2016 Jul;8(7):756-63. doi: 10.1136/neurintsurg-2015-011811. Epub 2015 Jun 24.

ID	Term
D054854	Vertebroplasty
D060826	Cementoplasty
D019637	Orthopedic Procedures
D013812	Therapeutics