Skip to content

Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial

Cost Effectiveness and Efficacy of Kypho and Vertebro Plasty Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00279877
Enrollment
112
Registered
2006-01-20
Start date
2005-05-31
Completion date
2011-09-30
Last updated
2016-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporotic Vertebral Compression Fractures

Brief summary

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

Interventions

PROCEDUREKyphoplasty

kyphoplasty

Sponsors

Cardinal Health
CollaboratorINDUSTRY
ArthroCare Corporation
CollaboratorOTHER
Cook Group Incorporated
CollaboratorINDUSTRY
University of Virginia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Back specific functional status(Roland)12 mo
Pain12 mo

Secondary

MeasureTime frame
Health status outcome measure(SF-36)12 mo

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026