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Spinal injuries, such as vertebral fractures, often result in a significant instability of the spine and lead to acute or delayed neurological deficits. Depending on the type of injury there are various methods available to stabilize the spine. The proposed study should clarify whether the combined reduction and fixation with a minimally invasive approach can actually be done with the same precision as in a conventional approach. The primary endpoint of this investigation is the monosegmental anterior wedge angle (AWA), and its maintenance over the first 6 postoperative weeks. It is the aim of the study to gather key radiological, clinical and subjective patient outcome parameters for its patient population that will allow to compare the results to a historical group of patients. The study design is non-interventional, prospective, open,and multicentric.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally invasive Approach | Patients with a thoracolumbar Fracture A3.1 to A 3.3 treated by fracture fixation by a minimally invasive approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fracture Fixation | Device | Thoracolumbar Fracture Fixation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anterior wedge angle (AWA) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss of the patient during surgery to stabilize the spine fracture | intraoperative | |
| OP duration | intraoperative | |
| Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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adult patients
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| Name | Affiliation | Role |
|---|---|---|
| Hans Goost, MD | University Hospital, Bonn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vinzenz-Pallotti-Hospital | Bergisch Gladbach | 51429 | Germany | |||
| Universitätsklinik Bonn, Abteilung für Unfallchirurgie |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Intraop and Postop |
| VAS Spine Score | 3 days and 6 weeks |
| VAS pain score | 3 days and 6 weeks |
| accompanying pain medication (or "self medication") | 6 weeks |
| patient satisfaction with operational results | The patient is asked the question whether he is satisfied with the results of the operation, he has the choice between six answers: very satisfied, satisfied, partly satisfied, unsatisfied, no comment | 6 weeks |
| Hospital length of stay | discharge |
| Bonn |
| 53127 |
| Germany |
| Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinik Köln | Cologne | 50924 | Germany |
| Abteilung für Orthopädie und Unfallchirurgie, Krankenhaus Wermelskirchen | Wermelskirchen | 42929 | Germany |