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| Name | Class |
|---|---|
| Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA | OTHER_GOV |
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The purpose of this study is to evaluate if an early mobilization after distal radius fractures treated by surgery leads to an better functional outcome then immobilization after surgery for 5 weeks in a cast
All patients with a distal radius fracture treated by surgery (palmar angle stable plate) will be included in this study and randomised into two groups according the CONSORT Guidelines of Prospective Randomised Trails. One group ("early mobilisation") receive a removable plastic cast for one week and are allowed to move the wrist directly postoperative.
The other group ("control group") received a non removable cast for 5 weeks. Both groups underwent physiotherapy two times a week. The control group was only allowed to move the closed-by joints.
In the 6., 9., 12. postoperative week, a half and one year after the operation the patients underwent range of motion (ROM), grip strength measurement and pain according to the visual analogue scale (VAS). Hand function will be analysed according the PRWE (Patient-Rated Wrist Evaluation) Score, DASH (Disabilities of the Arm, Shoulder and Hand) Score and Mayo Wrist Score.
Inclusion criteria:
Exclusion criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Mobilisation | Active Comparator | receives a removable plastic cast for one week and is allowed to move the wrist directly postoperative. Interventions:
Follow-up: 6., 9., 12. postoperative week, a half and one year after surgery |
|
| Cast Group | Active Comparator | receives a non removable cast for 5 weeks Interventions:
Follow-up: 6., 9., 12. postoperative week, a half and one year after surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | DASH Score, PRWE Score, Mayo Wrist Score |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional Outcome as measured by visual analogue scale (VAS) | Pain evaluation according the VAS Score | one year |
| Functional Outcome as measured by Range of Motion (ROM) | Range of Motion measured in sagittal plane, frontal plane and forearm rotation | one year |
| Functional Outcome as measured by Patient - Rated Wrist Evaluation Score Patient - Functional Outcome as measured by Rated Wrist Evaluation (PRWE) Score | Questionnaire: PRWE Score | one year |
| Functional Outcome as measured by Disabilities of the Arm, Shoulder and Hand (DASH) Score | Questionnaire: DASH Score | One Year |
| Functional Outcome as measured by Mayo Wrist Score | Questionnaire: Mayo Wrist Score | One year |
| Radiological outcome as measured by X-Ray | Radiological outcome in x-ray of the Wrist in two planes | One Year |
| Functional Outcome as measured by Grip Strength | one year |
| Measure | Description | Time Frame |
|---|---|---|
| change Range of motion | 6., 9., 12. week postsurgery, a half and one year after surgery | |
| Change Pain | 6., 9., 12. week postsurgery, a half and one year after surgery | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Quadlbauer, M.D. | AUVA Traumazentrum Vienna Site UKH Meidling | Principal Investigator |
| Martin Leixnering, M.D. | AUVA Traumazentrum Vienna Site UKH Meidling | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austrian Workers' Compensation Board Trauma Hospital Lorenz Böhler | Vienna | 1200 | Austria |
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D014965 | X-Rays |
| D018737 | Hand Strength |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| X- Ray | Radiation | X-ray exposures in two planes 6., 9., 12. postoperative week, half and one year after surgery |
|
| Grip Strength | Other | Grip strength measurement |
|
| VAS Score | Other | Measurement pain according to the visual analogue scale (VAS) |
|
| Range of Motion measurement | Other | Angle measurement of the active range of motion in the wrist |
|
| Change Disabilities of the Arm, Shoulder and Hand (DASH) Score |
| 6., 9., 12. week postsurgery, a half and one year after surgery |
| Change Patient-Rated Wrist Evaluation (PRWE) Score | 6., 9., 12. week postsurgery, a half and one year after surgery |
| Change Mayo Wrist Score | 6., 9., 12. week postsurgery, a half and one year after surgery |
| Change X-Ray | X-Ray of the wrist in two planes | 6., 9., 12. week postsurgery, a half and one year after surgery |
| Grip strength | 6., 9., 12. week postsurgery, a half and one year after surgery |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D053580 | Muscle Strength |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |