Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures

Study Overview
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Brief Summary
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The purpose of this study is to compare the radiographic and clinical outcomes after short versus conventional plaster cast fixation time in reduced distal radius fractures.

Detailed Description
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Displaced distal radius fractures treated with closed reduction and plaster cast fixation are radiographed 10 days (range 8-13 days) after reduction and randomized to one of two study arms; immediate removal of plaster cast or continued fixation in plaster cast for another 3 weeks. Radiographic and Clinical outcome measurements at 1, 4 and 12 months

Official Title
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A Comparison of Radiographic and Clinical Results After Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures

Conditions
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Colles' Fracture

Intervention / Treatment
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* Device: 10-day cast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Distal radius fracture with intact ulna (except for processus styloideus ulnae) Dorsal angulation 5-40 degrees Axial compression < 4 mm Intra articular step-off < 1 mm Low energy trauma Closed fracture Suitable for treatment with closed reduction and plaster cast fixation Exclusion Criteria: Fracture older than 3 Days Previously fractured ipsi- or contralateral wrist Dementia Inflammatory joint disorder

Ages Eligible for Study
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Minimum Age: 50 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10-day cast<br>Removal of plaster cast 10 Days after reduction | Device: 10-day cast<br>* Removal of plaster cast fixation 10 days after reduction<br>|
| No Intervention: 1-month cast<br>Removal of plaster cast 1 month after reduction | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic displacement | Change in dorsal angulation, radial angulation and axial compression between follow-ups. | At admission, 10 days, 1 month and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip strength | Grip strength compared to uninjured side at 1, 4 and 12 months | Uninjured side. Injured side at 1, 4 , 12 months | 
| Range of motion | Range of motion in dorsal extension, volar flexion, supination and pronation compared to uninjured side at 1, 4 and 12 months. | Uninjured side. Injured side at 1, 4 and 12 months | 
| Assessment of pain intensity | Average pain over the last 24 h assessed with a visual analogue scale (VAS) at 10 days, 1, 4 and 12 months | 10 days, 1, 4 and 12 months | 
| Assessment of functional outcome with three different functional assessment scores; 1,The modified de Bruijn wrist score 2, The modified Mayo wrist scoring chart 3, The Gartland and Werley Demerit wrist point system modified by Sarmiento. | The three functional assessment scores are composite outcome measures consisting of multiple measures (results to be reported as single values for each Group), | 12 months |