Percutaneous Vertebroplasty: Prophylactic Treatment of Adjacent Vertebra

NCT00635297 — Not applicable, Suspended, 100 participants, Ullevaal University Hospital

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

Registry	NCT00635297
Status	Suspended - Problems with patient recruitement
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	100 (Estimated)
Sponsor	Ullevaal University Hospital (Other)
Conditions	Osteoporosis, Vertebral Fracture
Interventions	Percutaneous vertebroplasty (Procedure)
Dates	start 2008-04-01, primary completion 2009-04-01 (estimated), completion 2009-04-01 (estimated), first posted 2008-03-13, last updated 2010-03-03
Locations	1 site in Norway

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
1	Active comparator	Procedure: Percutaneous vertebroplasty	50 osteoporotic patients with a vertebral insufficiency fracture will receive treatment of the vertebrae with standard vertebroplasty
2	Experimental	Procedure: Percutaneous vertebroplasty	50 osteoporotic patients with a vertebral insufficiency fracture will receive treatment of the vertebrae with standard vertebroplasty. The adjacent vertebrae will be treated with 3-5 ml of PMMA

Percutaneous vertebroplasty (Procedure), also known as PMMA: PMMA injection 3-10 milliliter in each treated vertebrae

+Outcome measures

Primary outcomes

Refracture rate based on MRI and CT after 3 months and one year [3 months and one year]

Secondary outcomes

Pain relief after the procedure based on VAS [3 months and one year]

+Eligibility

Sex: All, ages: 50 Years to any

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

+Locations (1)

Facility	City	Country	Status
Nevroradiologisk avdeling Ullevål universitetssykehus HF	Oslo, Oslo	Norway

+Investigators

Per Hj Nakstad, Phd, Study director, Nevroradiologisk avdeling Ullevål Universitetssykehus HF