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 of protocol
Not provided at time of registration
Contact information
Dr Frank Kandziora
Scientific
Scientific
Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie
Berufsgenossenschaftliche Unfallklinik
Friedberger Landstraße 430
Frankfurt am Main
60389
Germany
| Phone | +49 (0) 69 475 2016 |
|---|---|
| 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 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 | 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 |
| Completion date | 01/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target number of participants | 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
60389
Germany
Sponsor information
Centre for Spinal Surgery and Brain Trauma (Zentrum für Wirbelsäulenchirurgie und Neurotraumatologie) Germany
Government
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 |
|---|---|
| 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 |
