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| Name | Class |
|---|---|
| Deutsche Arthrose-Hilfe | OTHER |
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Metacarpal V fractures are injuries of the upper extremities. They occur frequently, primarily in young adults.These fractures are caused by falling on the fist, sports accidents and direct or indirect forces.
Surgical intervention is necessary for fractures with a strong palmar angulation of the metacarpal bone or rotational deformity of the small finger. Due to the absence of guideline recommendations decisions about therapy are made taking into account logistical aspects, available hardware, individual expertise and preferences. The objective of the study is to compare the advantages and disadvantages of single versus double Kirschner wires for intramedullary fixation of metacarpal V fractures in order to standardize national therapy procedures.
Primary hypothesis:
In the surgical therapy of the dislocated and/or rotational deformed metacarpal V neck fracture, osteosynthesis with a single Kirschner wire is not inferior to osteosynthesis with a double Kirschner wire with regard to the functional outcome after 6 month, as measured with the Disabilities of the Arm, Shoulder and Hands Score (DASH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Kirschner Wire | Active Comparator | Antegrade intramedullary fixation of with a single Kirschner wire. |
|
| Double Kirschner Wire | Active Comparator | Antegrade intramedullary fixation with double Kirschner wire. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Kirschner Wire | Device |
| ||
| Double Kirschner Wire |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in functional outcome of the therapy with single or double Kirschner wires measured with the DASH score | 6 months after randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Malposition or angulation in the frontal and sagittal planes of max. 5° | 6 months after randomisation | |
| Shortening of the metacarpus >2mm | 6 months after randomisation | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Eisenschenk, Prof. Dr. | University Medicine Greifswald | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medicine Greifswald | Greifswald | Mecklenburg-Vorpommern | 17489 | Germany | ||
| Sana Clinical Centre Lichtenberg |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 17, 2020 | |
| Reset | Jul 8, 2020 |
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| Device |
|
| Palmar angulation >30° |
| 6 months after randomisation |
| Non-union/Pseudarthrosis | 6 months after randomisation |
| Limitation of fist closure | 6 months after randomisation |
| Flexion or extension lag | 6 months after randomisation |
| Pain intensity <10 points (VAS) | 6 months after randomisation |
| Duration of surgical intervention | 6 months after randomisation |
| Rate of re-interventions | 6 months after randomisation |
| Rate of infections | 6 months after randomisation |
| Rate of perforation/dislocation/break of the fracture fixation devices | 6 months after randomisation |
| Duration of inability to work | 6 months after randomisation |
| Berlin |
| 10365 |
| Germany |
| Vivantes Hospital Am Urban | Berlin | 10967 | Germany |
| Trauma Hospital Berlin | Berlin | 12683 | Germany |
| University Medicine Düsseldorf | Düsseldorf | 40225 | Germany |
| District Hospital Gummersbach | Gummersbach | 51643 | Germany |
| BG Kliniken Bergmannstrost | Halle | 06112 | Germany |
| Berufsgenossenschaftliches Unfallkrankenhaus Hamburg | Hamburg | 21033 | Germany |
| University Medicine Hamburg-Eppendorf | Hamburg | 220246 | Germany |
| Berufsgenossenschaftliches Unfallkrankenhaus Ludwigshafen | Ludwigshafen | 67071 | Germany |
| University Medicine Rostock | Rostock | 18055 | Germany |
| Municipal Clinic Solingen | Solingen | 42663 | Germany |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 17, 2020 | Jul 8, 2020 |
| ID | Term |
|---|---|
| D001864 | Bone Wires |
| ID | Term |
|---|---|
| D016268 | Internal Fixators |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D053831 | Surgical Fixation Devices |
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