Early Mobilization of Operatively Stabilized Distal Radius Fractures - a Randomized Controlled Trail

Study Overview
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Brief Summary
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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

Detailed Description
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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: Age ≥ 18 and ≤ 75 years A2 - C3 distal radius fracture no acute or older injury that influences hand function operative stabilized by palmar angle stable plate Exclusion criteria: Age ≥ 76 years Age < 18 years C3.3 radius fracture acute or preexisting injures that influences hand function pregnancy neurologic disorders incapacitated people

Official Title
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Early Mobilization of Operatively Stabilized Distal Radius Fractures - a Randomized Controlled Trail

Conditions
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Closed Fracture of Lower End of Radius and Ulna

Intervention / Treatment
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* Other: Questionnaire
* Radiation: X- Ray
* Other: Grip Strength
* Other: VAS Score
* Other: Range of Motion measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 and ≤ 75 years A2 - C3 distal radius fracture no acute or older injury that influences hand function operative stabilized by palmar angle stable plate Exclusion Criteria: Age ≥ 76 years Age < 18 years C3.3 radius fracture acute or preexisting injures that influences hand function pregnancy neurologic disorders incapacitated people

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early Mobilisation<br>receives a removable plastic cast for one week and is allowed to move the wrist directly postoperative. Interventions: Range of Motion measurement (ROM), Grip strength measurement, VAS Score according to the visual analogue scale (). Questionnaire: PRWE Score, DASH Score and Mayo Wrist Score. X- Rays in two planes. Follow-up: 6., 9., 12. postoperative week, a half and one year after surgery | Other: Questionnaire<br>* DASH Score, PRWE Score, Mayo Wrist Score<br>Radiation: X- Ray<br>* X-ray exposures in two planes 6., 9., 12. postoperative week, half and one year after surgery<br>Other: Grip Strength<br>* Grip strength measurement<br>Other: VAS Score<br>* Measurement pain according to the visual analogue scale (VAS)<br>Other: Range of Motion measurement<br>* Angle measurement of the active range of motion in the wrist<br>|
| Active Comparator: Cast Group<br>receives a non removable cast for 5 weeks Interventions: Range of Motion measurement (ROM), Grip strength measurement, VAS Score according to the visual analogue scale (). Questionnaire: PRWE Score, DASH Score and Mayo Wrist Score. X- Rays in two planes. Follow-up: 6., 9., 12. postoperative week, a half and one year after surgery | Other: Questionnaire<br>* DASH Score, PRWE Score, Mayo Wrist Score<br>Radiation: X- Ray<br>* X-ray exposures in two planes 6., 9., 12. postoperative week, half and one year after surgery<br>Other: Grip Strength<br>* Grip strength measurement<br>Other: VAS Score<br>* Measurement pain according to the visual analogue scale (VAS)<br>Other: Range of Motion measurement<br>* Angle measurement of the active range of motion in the wrist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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distal radius fractures, early mobilization, postoperative treatment, outcome