Percutaneous Vertebroplasty: Prophylactic Treatment of Ad... | NCT00635297

Studies
Percutaneous Vertebroplasty: Prophylactic Treatment of Adjacent Vertebra

NCT00635297

Sponsor

Ullevaal University Hospital

Status

Suspended

Last Update Posted

Mar 3, 2010Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Osteoporosis
Vertebral Fracture

Interventions

Percutaneous vertebroplasty

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Problems with patient recruitement

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Apr 2009Estimated

Completion Date

Apr 2009Estimated

First Submitted Date

Mar 5, 2008

First Submission Date that Met QC Criteria

Mar 5, 2008

First Posted Date

Mar 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2010

Last Update Posted Date

Mar 3, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	50 osteoporotic patients with a vertebral insufficiency fracture will receive treatment of the vertebrae with standard vertebroplasty	Procedure: Percutaneous vertebroplasty
2	Experimental	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	Procedure: Percutaneous vertebroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Percutaneous vertebroplasty	Procedure	PMMA injection 3-10 milliliter in each treated vertebrae	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Refracture rate based on MRI and CT after 3 months and one year		3 months and one year

Secondary Outcomes

Measure	Description	Time Frame
Pain relief after the procedure based on VAS		3 months and one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Per Hj Nakstad, Phd	Nevroradiologisk avdeling Ullevål Universitetssykehus HF	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nevroradiologisk avdeling Ullevål universitetssykehus HF		Oslo	Oslo	0407	Norway

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis
D016103	Spinal Fractures
D050723	Fractures, Bone

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019904	Polymethyl Methacrylate

Ancestor Terms

ID	Term
D008768	Methylmethacrylates
D011109	Polymethacrylic Acids
D000179	Acrylates
D000144	Acids, Acyclic

Browse Leaves

Not provided

Browse Branches

Not provided