Percutaneous Vertebroplasty: Prophylactic Treatment of Adjacent Vertebra

Osteoporosis Clinical Trial

Official title:

Percutaneous Vertebroplasty.Study of Refracture Rates After Prophylactic Vertebroplasty of Adjacent Vertebrae

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00635297
• Other study ID #: 889 VP
• Status: Suspended
• Phase: N/A
• First received: March 5, 2008
• Last updated: March 2, 2010
• Start date: April 2008
• Est. completion date: April 2009

Study information

• Verified date: January 2008
• Source: Ullevaal University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

Percutaneous vertebroplasty is a treatment for painful osteoporotic compression fractures. Multiple reports have shown as high as 20 % refracturerates in vertebrae adjacent to those that have been treated with percutaneous vertebroplasty.

The purpose of the study is to determine if prophylactic vertebroplasty of unfractured vertebrae adjacent to the treated fractured vertebrae can reduce the rates of refracture in adjacent vertebrae.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• CT and MRI proven non healed painful osteoporotic compression fracture in the thoracic and lumbar spine.

Exclusion Criteria:

• Infection

• High grade spinal stenosis

• Contraindications to MRI

• Dementia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Spinal Fractures
• Vertebral Fracture

Intervention

Procedure:
• Percutaneous vertebroplasty
PMMA injection 3-10 milliliter in each treated vertebrae

Locations

Country	Name	City	State
Norway	Nevroradiologisk avdeling Ullevål universitetssykehus HF	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Refracture rate based on MRI and CT after 3 months and one year		3 months and one year	Yes
Secondary	Pain relief after the procedure based on VAS		3 months and one year	Yes