Comparison of minimally invasive percutaneous vs. open dorsal fixation and additional thoracoscopic ventral spondylodesis in AO/OTA type A3 thoracolumbar fractures
Organizational Data
- DRKS-ID:
- DRKS00015693
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2018-11-07
- Last update in DRKS:
- 2020-12-07
- Registration type:
- Retrospective
Acronym/abbreviation of the study
A3
URL of the study
No Entry
Brief summary in lay language
Fractures of the throracolumbar transition are the most frequent fractures of the spine. The surgical treatment of these fractures is controversially discussed. The aim of this study was to compare the treatment strategies of two large German trauma centers for fractures of thoracic vertebrae 11 and 12 as well as lumbar vertebrae 1 and 2. Center A operates on the patients in minimally invasive technique, center B in open technique. It includes all patients who were treated from 01.07.2012 to 31.05.2014 due to a fracture of the thoracolumbar transition by dorsal stabilization in open or less invasive technique in the trauma surgery of the University Hospital Leipzig as well as the BG trauma clinic in Murnau. The aim is to examine the radiological and functional outcome after at least 2 years. Hypotheses: The technique of minimally invasive vestibular stabilization shows an equally good reduction rate compared to the open technique with a lower complication rate. 2. 2. due to a stringent time-delayed indication for ventral care, an additive ventral care can be dispensed with in a relevant proportion of patients.
Brief summary in scientific language
Fractures of the thoracolumbar transition are the most frequent fractures of the spinal column and can lead to considerable functional limitations. The surgical treatment of these injuries by minimally invasive percutaneous dorsal stabilization has become increasingly important in recent years. However, the superiority of this surgical technique over the open technique is controversially discussed. The aim of this study was therefore to compare the treatment strategies of two trauma centers exclusively for AO type A3 fractures of the thoracolumbar transition with regard to clinical and radiological outcome. The main difference between the treatment of both centers is the minimally invasive and the open surgical technique. Methodology Included in this retrospective study were patients between 18 and 65 years of age with AO type A3 fractures of the vertebral bodies BWK 11 - LWK 2 without neurological deficits who were dorsally stabilized by minimally invasive or open technique between 2013 - 2015. Among others, osteoporotic vertebral body fractures and fractures of other AO classifications as well as polytraumatized patients were excluded. Patients were evaluated clinically using validated scores (VAS score, Owestry Disability score, SF-36) and radiologically by measuring bisegmental kyphosis angle and pelvic alignment at least 24 months postoperatively. Hypotheses: 1 The technique of minimally invasive dorsal stabilization shows an equally good reduction rate compared to the open technique with a lower complication rate. 2 Due to a stringent time-delayed indication for ventral restoration, an additive ventral restoration can be dispensed with in a relevant proportion of patients.
Health condition or problem studied
- ICD10:
- S32.01
- ICD10:
- S32.02
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Minimally invasive surgical technique, early additive ventral stabilization The examination takes place at least 2 years after the operation. Evaluation of X-ray images VAS Spine Score Oswestry Disability Score SF-36 Quality of life
- Arm 2:
- Open operative technique, late additiv ventral Stabilisation The examination takes place at least 2 years after the operation. Evaluation of X-ray images VAS Spine Score Oswestry Disability Score SF-36 Quality of life
Endpoints
- Primary outcome:
- Bisegmental kyphotic angle, radiological measurement Functional outcome is ODI-Score by questionnaire
- Secondary outcome:
- Sagital Alignment radiological SF-36, VAS-Score by questionnaire
Study Design
- Purpose:
- Basic research/physiological study
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Orthopädie und Unfallchirurgie Leipzig
- University medical center Orthopädie und Unfallchirurgie Leipzig
- Medical center BG Klinik Unfallchirurgie Murnau
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2016-12-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2017-12-01
- Target Sample Size:
- 87
- Final Sample Size:
- 87
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 65 Years
- Additional Inclusion Criteria:
- Inclusion criteria: Detailed information and education Signature of informed consent after sufficient time for reflection Operative care according to the above techniques in the period 01.07.2012 to 31.05.2014. Age 18-65 years
Exclusion Criteria
Exclusion criteria: Vertebral body fractures of other AO classifications Patients with neurological deficits fractures of other genesis (e.g. tumor / metastasis) incapacity to consent Osteoporotic fractures Polytrauma with ISS>16 Kypho or vertebroplasty additives Long-distance dorsal stabilizations (over more than 2 motion segments) pregnancy
Addresses
Primary Sponsor
- Address:
- Klinik und Poliklinik für Orthopädie, Unfallchirurgie und Plastische Chirurgie der Universitätsklinik LeipzigLiebigstr 2004103 LeipzigGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- BG Unfallklinik MurnauChristoph ErichsenProf. Küntscher Str. 882418 MurnauGermany
- Telephone:
- 08841 48480
- Fax:
- 08841 48 4573
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- BG Unfallklinik MurnauChristoph ErichsenProf. Küntscher Str. 882418 MurnauGermany
- Telephone:
- 08841 48480
- Fax:
- 08841 48 4573
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- BG Unfallklinik MurnauChristoph ErichsenProf. Küntscher Str. 882418 MurnauGermany
- Telephone:
- 08841 48480
- Fax:
- 08841 48 4573
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Klinik und Poliklinik für Orthopädie, Unfallchirurgie und Plastische Chirurgie der Universitätsklinik LeipzigLiebigstr 2004103 LeipzigGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Geschäftsstelle der Ethik-Kommission an der Medizinischen Fakultät der Universität Leipzig c/o Zentrale PoststelleLiebigstraße 1804103 LeipzigGermany
- Telephone:
- +49-341-9715490
- Fax:
- +49-341-9715499
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://home.uni-leipzig.de/ethik
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2016-10-12
- Ethics committee number:
- 276/16-ek
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2016-11-29
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry