VertebrOpLasty Versus Conservative Treatment in Acute Non... | NCT01643395

Studies
VertebrOpLasty Versus Conservative Treatment in Acute Non Osteoporotic Vertebral Fractures

NCT01643395

Sponsor

University Hospital, Clermont-Ferrand

Status

Completed

Last Update Posted

Feb 17, 2014Estimated

Enrollment

99Actual

Phase

Phase 3

Conditions

Vertebral Compression Fracture
Spinal Trauma

Interventions

vertebroplasty
conservative therapy

Countries

France

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

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Jul 13, 2012

First Submission Date that Met QC Criteria

Jul 17, 2012

First Posted Date

Jul 18, 2012Estimated

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

Feb 14, 2014

Last Update Posted Date

Feb 17, 2014Estimated

Description Module

Brief Summary

The purpose of this protocol is to prove the efficacy of vertebroplasty in patients suffering from acute non osteoporotic vertebral compression fracture.

Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse.

Our study will compare vertebroplasty versus conservative therapy (brace).

Detailed Description

The study is a prospective, randomized trial comparing conservative treatment (brace) and vertebroplasty in acute (less than 15 days after trauma) traumatic vertebral compression fracture (VCF) type A according Magerl classification

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

99Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vertebroplasty	Experimental		Other: vertebroplasty
conservative therapy (brace)	Other		Other: conservative therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vertebroplasty	Other	Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse	vertebroplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disability scale		at 1 month

Secondary Outcomes

Measure	Description	Time Frame
Spine radiological measurements		at 1, 3 and 6 months
Disability and qol		at 3 and 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 - 70 year old
volunteers
Vertebral compression fractures Magerl type A
Acute Trauma (less than 15 days)
Between T5 and L5
Patient able to undergo both vertebroplasty and conservative treatment
Consent form obtained

Exclusion Criteria:

Neural arch fracture
C1 to T4 fracture
Neurologic symptoms caused by the fracture
Encephalic trauma with Glasgow Coma Scale less than 15
Ongoing cancer
Routine painkillers intake
Local or systemic infection
Coagulation's disorder
Pregnancy
Involvement in an another clinical trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emmanuel CHABERT	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Clermont-Ferrand		Clermont-Ferrand		63003	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37030247	Derived	Chabert E, Hugonnet E, Kastler A, Sakka L, Rabbo FA, Zerroug A, Coudeyre E, Pereira B, Coll G. Vertebroplasty versus bracing in acute vertebral compression fractures: A prospective randomized trial. Ann Phys Rehabil Med. 2023 Sep;66(6):101746. doi: 10.1016/j.rehab.2023.101746. Epub 2023 Apr 6.

ID	Term
D014947	Wounds and Injuries
D050815	Fractures, Compression

ID	Term
D060826	Cementoplasty
D019637	Orthopedic Procedures
D013812	Therapeutics
D013514	Surgical Procedures, Operative