NCT00689923

Brief Summary

Th low viscosity cement injection is safe in vertebroplasty procedure with Comparacle out come in pain relief.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Status
unknown

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

November 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Last Updated

June 4, 2008

Status Verified

May 1, 2008

Enrollment Period

11 months

First QC Date

June 1, 2008

Last Update Submit

June 3, 2008

Conditions

Outcome Measures

Primary Outcomes (1)

  • pain relief

    immediately after procedure

Secondary Outcomes (1)

  • cement leak

    immediate after procedure

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

painful vertebral compression fracture

You may qualify if:

  • all painful fracture that can not be relieved by pain killer.

You may not qualify if:

  • infection and malignancy in local region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OsteoporosisFractures, Compression

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesFractures, BoneWounds and Injuries

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 1, 2008

First Posted

June 4, 2008

Study Start

November 1, 2007

Primary Completion

October 1, 2008

Last Updated

June 4, 2008

Record last verified: 2008-05