NCT00166374

Brief Summary

Patients with vertebral compression fracture will be treated cement injection into the spine and monitored using standard evaluations.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

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

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

January 20, 2010

Status Verified

January 1, 2010

First QC Date

September 12, 2005

Last Update Submit

January 19, 2010

Conditions

Back Pain

Outcome Measures

Primary Outcomes (2)

  • pain

  • disability

Interventions

balloon kyphoplastyPROCEDURE

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
vertebral compression fracture

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

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Back Pain

Interventions

Kyphoplasty

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

VertebroplastyCementoplastyOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • H. Gordon Deen, Jr., M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

January 20, 2010

Record last verified: 2010-01

Locations

US(1)