Condition category
Injury, Occupational Diseases, Poisoning
Date applied
24/01/2011
Date assigned
14/03/2011
Last edited
14/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Frank Kandziora

ORCID ID

Contact details

Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie
Berufsgenossenschaftliche Unfallklinik
Friedberger Landstraße 430
Frankfurt am Main
60389
Germany
+49 (0) 69 475 2016
Frank.Kandziora@BGU-Frankfurt.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised controlled trial for treatment of incomplete burst fractures (AO Type A3.1) with dorsal or dorso-ventral proceeding

Acronym

A3.1

Study hypothesis

The objective of the study:
1.To compare different operative (OP) methods with each other
1.1.Minimal clinical relevant difference for Visual Analogue Scale (VAS) within 5 points and 10 points
1.2. Minimal clinical relevant difference for bisegmental ground cover plate angle (GDW) 5 grade

Study options:
1. Dorsal mono/bisegmental vs. ventral monosegmental
2. Dorsal mono/bisegmental vs. dorso-ventral
3. Dorsal mono/bisegmental vs. conservative

The dorso-ventral stabilisation will give better radiological results than isolated dorsal stabilisation (follow-up 2 years)
The dorso-ventral stabilisation will receive the same results as the isolated dorsal stabilisation (follow-up 2 years)
The dorso-ventral stabilisation will receive better radiological results than the isolated dorsal stabilisation (follow-up 5 years)
The dorso-ventral stabilisation receives better results than the isolated dorsal stabilisation (follow-up 5 years)
The rate of revisions is each dorso-ventral stabilisations less than the rate after isolated dorsal stabilisations (follow-up 5 years)

Ethics approval

Ethics Commission in the Hessen State Medical Association (Ethikkommission bei der Landesärztekammer Hessen), approved on 07.07.2010, reference number: FF23/2010

Study design

Single-centre prospective randomised controlled case-control-trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

A3.1 burst fracture

Intervention

Dorsal or dorso-ventral stabilisation of spine fractures

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Pre OP:
1.1. Oswestry Disablity Index
1.2. EQ-5D
1.3. VAS
1.4. Intake of analgesics
1.5. VAS-Spine Score
2. Post OP 3 months/12 months/24 months :
2.1. Oswestry Disablity Index,
2.2. EQ-5D
2.3. VAS
2.4. Intake of analgesics
2.5. VAS-Spine Score
2.6. Odom's criteria

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/09/2009

Overall trial end date

01/09/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age between 18 and 60 years
2. Fracture type A3.1.1
3. Localisation Th11 – L3
4.Mono-injury

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Systemic diseases for example rheumatic diseases,human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), tumor, ankolysing sponylitis (M. Bechterew), etc
2. Osteoporosis (T-Score less than minus 2.5)
3. Polytrauma, multiocular spine injuries
4. No ventral OP possible, pulmonary diseases, obesity (adipositas), already ventral surgery received, etc
5. For study option 2
5.1. Neurologic deficit after spine surgery]

Recruitment start date

01/09/2009

Recruitment end date

01/09/2012

Locations

Countries of recruitment

Germany

Trial participating centre

Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie
Frankfurt am Main
60389
Germany

Sponsor information

Organisation

Centre for Spinal Surgery and Brain Trauma (Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie) Germany

Sponsor details

Priv.-Doz. Dr. med. Frank Kandziora
Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie
Berufsgenossenschaftliche Unfallklinik
Friedberger Landstraße 430
Frankfurt am Main
60389
Germany
+49 (0) 69 475 2016
Frank.Kandziora@BGU-Frankfurt.de

Sponsor type

Government

Website

http://www.bgu-frankfurt.de/index.php?lang=de

Funders

Funder type

Government

Funder name

Centre for Spinal Surgery and Brain Trauma (Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes