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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN92182348
Enrollment
60
Registered
2011-03-14
Start date
2009-09-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A3.1 burst fracture Injury, Occupational Diseases, Poisoning Injury of spinal cord

Interventions

Dorsal or dorso-ventral stabilisation of spine fractures

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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]

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
No secondary outcome measures

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026