Treatment of incomplete burst fractures (AO Type A3.1) with dorsal or dorso-ventral proceeding

ISRCTN	ISRCTN92182348
DOI	https://doi.org/10.1186/ISRCTN92182348
Secondary identifying numbers	N/A

Submission date: 24/01/2011
Registration date: 14/03/2011
Last edited: 14/03/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Dr Frank Kandziora
Scientific

Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie
Berufsgenossenschaftliche Unfallklinik
Friedberger Landstraße 430
Frankfurt am Main
60389
Germany

Phone	+49 (0) 69 475 2016
Email	Frank.Kandziora@BGU-Frankfurt.de

Study information

Study design	Single-centre prospective randomised controlled case-control-trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Randomised controlled trial for treatment of incomplete burst fractures (AO Type A3.1) with dorsal or dorso-ventral proceeding
Study 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(s)	Ethics Commission in the Hessen State Medical Association (Ethikkommission bei der Landesärztekammer Hessen), approved on 07.07.2010, reference number: FF23/2010
Condition	A3.1 burst fracture
Intervention	Dorsal or dorso-ventral stabilisation of spine fractures
Intervention type	Other
Primary outcome measure	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 study start date	01/09/2009
Overall study end date	01/09/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	60
Participant inclusion criteria	1. Age between 18 and 60 years 2. Fracture type A3.1.1 3. Localisation Th11 L3 4.Mono-injury
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

Study participating centre

Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie

Frankfurt am Main
60389
Germany

Sponsor information

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

Priv.-Doz. Dr. med. Frank Kandziora
Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie
Berufsgenossenschaftliche Unfallklinik
Friedberger Landstraße 430
Frankfurt am Main
60389
Germany

Phone	+49 (0) 69 475 2016
Email	Frank.Kandziora@BGU-Frankfurt.de
Website	http://www.bgu-frankfurt.de/index.php?lang=de
"ROR"	https://ror.org/04kt7f841

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan