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A single center, parallel group, prospective, randomized clinical trial was conducted at the department of Hand Surgery, ABC (Andre, Bernardo, Caetano) Foundation University Hospital, Santo Andre, Brazil. Two implants used for fixation in closed reduction of distal radius fractures were compared: the bridging dynamic Galaxy Wrist external fixator (Orthofix®, Verona) and the non-bridging Galaxy wrist external fixator system (Orthofix®, Verona).
Dynamic external fixator in the ETC (Early Total Care) of unstable DRFs (distal radius fractures) may be a good choice of treatment. Because it's fast, safe, minimally invasive and easily performed method, it could help in the inflammatory systemic response to trauma, unable earlier functional recovery and shorten the hospitalization time of these patients (elderly and polytrauma). From this, in this study to obtain relevant information about each type of treatment, avoid possible selection bias, information and confusion. Choose a reproducible and effective method (external fixator), which presents a cost / benefit compatible with our reality, but that generates doubt the best way to apply this "bridging" which is already used and that will be our control group and "non-bridging", which will be the group to be tested.
Rather than establishing the actual value of each of these procedures, is necessary to optimize and improve the quality of life of these patients in order to return to your personal and professional activities as soon as possible.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bridging (control group) | Placebo Comparator | External fixation in treatment the distal radius fracture |
|
| Nonbridging (tested group) | Active Comparator | External fixation in treatment the distal radius fracture improve grip strength? |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External fixation in treatment the distal radius fracture | Procedure | Compare two techniques |
|
| Measure | Description | Time Frame |
|---|---|---|
| Grip strenght | use the specific Jamar Hand Dynamometer to measure the arc of movement the wrist | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| range of wrist motion | use the specific goniometer to measure the arc of movement the wrist | 12 months |
| Radiograph assesment | Measure ulna and radial shortening, tilt palmar |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| D009104 | Multiple Trauma |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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Patients were randomized by drawing lots currency (Face = A - treatment with fixation "non-bridging"; Crown = B - Treatment with the method "bridging"), which were printed and placed in sealed envelopes before the study started.
| 12 months |
| DASH Questionnaire | measure life quality | 12 months |
| VAS (visual analog scale) | patient reported outcome (pain) in scale interval (0 until 10) | 12 months |