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Prospective RAndomized controlled multi centric evaluation of Stabilization Procedures for Unstable THoracolumbar spINE fractures.

Prospective RAndomized controlled multi centric evaluation of Stabilization Procedures for Unstable THoracolumbar spINE fractures. - RASPUTHINE

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00005286
Enrollment
246
Registered
2013-09-04
Start date
2013-10-02
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

incomplete cranial burst fracture within the thoraco-lumbar junction after posterior bisegmental fixation. T08.0

Interventions

Group 1: Following primary bisegmental stabilization patients will be screened according to the inclusion and exclusion criteria of the study. If a patient meet the study criteria an informed consent

Sponsors

Berufsgenossenschaftliche Unfallklinik Frankfurt am Main
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients between 18 and 65 years of age Fresh Magerl Type A3.1.1 fracture Fracture location: Th 11 – L 2 Posterior bisegmental stabilization Informed consent

Exclusion criteria

Exclusion criteria: Polytrauma (ISS > 16) Multilevel spinal fractures Pathological fractures Osteoporosis (T-Score 35 Existence of a serious language barrier Expected lack of compliance

Design outcomes

Primary

MeasureTime frame
Differences in pain related disorders of the back. Questionnaire: Oswestry Disability Index - German Version (ODI-G) Time points 3, 6, 12 and 24 months after inclusion.

Secondary

MeasureTime frame
Differences for the bisegmental kyphosis angle at the index level on lateral X-ray in standing position Time points: preoperatively (lying position), postoperatively, 3, 6, 12 and 24 months. The validated COBB angle method will be used to measure the kyphotic bisegmental alignment.

Countries

Germany

Contacts

Public ContactMatti Scholz

Berufsgenossenschaftliche Unfallklinik Frankfurt am Main

matti.scholz@bgu-frankfurt.de0049 69 475 1563

Outcome results

None listed

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