ClinicalTrials.gg
Sign In
CompletedNCT00279877Updated Aug 18, 2016

Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial

A Phase 3 interventional study of Kyphoplasty in Osteoporotic Vertebral Compression Fractures, sponsored by University of Virginia. Completed at 1 site in United States. Open to participants aged 50 Years to 100 Years. Per ClinicalTrials.gov, last updated 2016-08-18.

Sponsored by University of Virginia · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
50 Years to 100 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Osteoporotic Vertebral Compression Fractures

Browse trials for

03

In context

Fractures, Compression

50 studies on the registry are indexed under Fractures, Compression; 10 are open to participants now.

This study's enrollment of 112 is above the median of 73 across 32 interventional studies indexed under Fractures, Compression.

Browse Fractures, Compression studies →

Lead sponsor

University of Virginia is the lead sponsor of 675 studies on the registry; 138 are open to participants now.

Of its 61 completed or terminated interventional studies of FDA-regulated products, 42 (69%) have results posted.

Browse University of Virginia studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
112 participants (actual)

Study arms

  • Active comparator
    vertebroplasty

    vertebroplasty

    Procedure: Kyphoplasty

  • Active comparator
    kyphoplasty

    kyphoplasty

    Procedure: Kyphoplasty

Interventions

  • ProcedureKyphoplasty

    kyphoplasty

06

What researchers measure

Primary outcomes

  1. Back specific functional status(Roland)

    Time frame: 12 mo

  2. Pain

    Time frame: 12 mo

Secondary outcomes

  1. Health status outcome measure(SF-36)

    Time frame: 12 mo

07

Study locations

1 site
  • University of Virginia
    Charlottesville, Virginia 22908, United States
08

References and documents

Publications

  • 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. PubMed 26109687 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2005, a primary completion of Sep 2011 and a completion of Sep 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 18, 2006
First posted
Jan 20, 2006
Start
May 2005
Primary completionActual
Sep 2011
CompletionActual
Sep 2011
Last update
Aug 18, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00279877
Lead sponsor
University of Virginia
Collaborators
Cardinal Health, ArthroCare Corporation, Cook Group Incorporated
Responsible party
Avery Evans, MD (MD, University of Virginia) — Principal investigator
First posted
Jan 20, 2006
Start date
May 2005
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Aug 18, 2016

Study contacts

Avery Evans, M.D.
principal investigator · University of Virginia
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Fractures, Compression →

Other studies from this sponsor

University of Virginia →

Start the discussion