NCT00279877

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2005

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2006

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

August 18, 2016

Status Verified

August 1, 2016

Enrollment Period

6.3 years

First QC Date

January 18, 2006

Last Update Submit

August 17, 2016

Conditions

Osteoporotic Vertebral Compression Fractures

Outcome Measures

Primary Outcomes (2)

  • Back specific functional status(Roland)

    12 mo

  • Pain

    12 mo

Secondary Outcomes (1)

  • Health status outcome measure(SF-36)

    12 mo

Study Arms (2)

vertebroplasty

ACTIVE COMPARATOR

vertebroplasty

Procedure: Kyphoplasty

kyphoplasty

ACTIVE COMPARATOR

kyphoplasty

Procedure: Kyphoplasty

Interventions

KyphoplastyPROCEDURE

kyphoplasty

kyphoplastyvertebroplasty

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* \> or = 50 years of age * Compression fracture (T4-L5)within previous 12 mo. * Pain from compression fracture * No malignant tumor * No back surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

  • 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.

    PMID: 26109687DERIVED

MeSH Terms

Interventions

Kyphoplasty

Intervention Hierarchy (Ancestors)

VertebroplastyCementoplastyOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Avery Evans, M.D.

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 18, 2006

First Posted

January 20, 2006

Study Start

May 1, 2005

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

August 18, 2016

Record last verified: 2016-08

Locations

US(1)