Trial document
This trial has been registered retrospectively.
DRKS00005052
Trial Description
Title
Percutaneous Stabilization of thoracolumbal spine fractures
Trial Acronym
[---]*
URL of the Trial
[---]*
Brief Summary in Lay Language
We investigate in our study if percutaneous stabilization of spine fractures improves spine function. Furthermore, we want to check if there is an influence on stability and loss of correction.
Patient satisfaction, sport activity and time until return to work are evaluated as well.
Brief Summary in Scientific Language
Percutaneous Stabilization of thoracolumbal spine fractures
Organizational Data
- DRKS00005052
- 2013/09/23
- [---]*
- yes
- Approved
- 91/2011, Ethik-Kommission der Universität Witten/Herdecke
Secondary IDs
- [---]*
Health Condition or Problem studied
- spine fracture
- S32 - Fracture of lumbar spine and pelvis
Interventions/Observational Groups
- Minimal-invasive stabilized patients are followed up 9-12 months postoperatively. Clinical evaluation was performed by subjective evaluation of the final results by patients themselves
- Control Group (historical) from existing data
Characteristics
- Non-interventional
- Observational study
- Non-randomized controlled trial
- Open (masking not used)
- [---]*
- Historical
- Treatment
- Other
- N/A
- N/A
Primary Outcome
Spine function (VAS Spine Score) after implant removal (9-12 months postoperative)
Secondary Outcome
radiographic evaluation of the segmental kyphosis and the wedging deformity of the involved vertebral body performed during clinical follow up
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
- Medical Center
Recruitment
- Actual
- 2012/05/15
- 125
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 16 Years
- no maximum age
Additional Inclusion Criteria
a. Acute (< 3 weeks) traumatic injuries from T1 to L5 with percutaneous internal fixation
b.written consent
Exclusion Criteria
a. concomitant injuries, which influence spine function
b. pediatric fractures c. kyphoplasty d.no written consent
Addresses
-
start of 1:1-Block address primary-sponsor
- Universitätsklinikum Düsseldorf, Klinik für Unfall- und Handchirurgie
- Mr. Dr. med. Tobias Gensior
- Moorenstr. 5
- 40225 Düsseldorf
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 0049 211 8104400
- -
- tobias.gensior at med.uni-duesseldorf.de
- http://www.uniklinik-duesseldorf.de
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Universitätsklinikum Düsseldorf, Klinik für Unfall- und Handchirurgie
- Mr. Dr. med. Tobias Gensior
- Moorenstr. 5
- 40225 Düsseldorf
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0049 211 8104400
- -
- tobias.gensior at med.uni-duesseldorf.de
- http://www.uniklinik-duesseldorf.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Universitätsklinikum Düsseldorf, Klinik für Unfall- und Handchirurgie
- Mr. Dr. med. Tobias Gensior
- Moorenstr. 5
- 40225 Düsseldorf
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0049 211 8104400
- -
- tobias.gensior at med.uni-duesseldorf.de
- http://www.uniklinik-duesseldorf.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Universitätsklinikum Düsseldorf, Klinik für Unfall- und Handchirurgie
- Mr. Dr. med. Tobias Gensior
- Moorenstr. 5
- 40225 Düsseldorf
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- 0049 211 8104400
- -
- tobias.gensior at med.uni-duesseldorf.de
- http://www.uniklinik-duesseldorf.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
- [---]*
Trial Publications, Results and other Documents
- [---]*