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

ISRCTN	ISRCTN92182348
DOI	https://doi.org/10.1186/ISRCTN92182348
Protocol serial number	N/A
Sponsor	Centre for Spinal Surgery and Brain Trauma (Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie) Germany
Funder	Centre for Spinal Surgery and Brain Trauma (Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie) (Germany)

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 of protocol

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

Primary study design	Interventional
Study design	Single-centre prospective randomised controlled case-control-trial
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	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
Health condition(s) or problem(s) studied	A3.1 burst fracture
Intervention	Dorsal or dorso-ventral stabilisation of spine fractures
Intervention type	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/09/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Key inclusion criteria	1. Age between 18 and 60 years 2. Fracture type A3.1.1 3. Localisation Th11 L3 4.Mono-injury
Key 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]
Date of first enrolment	01/09/2009
Date of final enrolment	01/09/2012

Locations

Countries of recruitment

Germany

Study participating centre

Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie

Frankfurt am Main
60389
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes