Four or Six Weeks of Immobilization in the Conservative Treatment of Distal Radius Fractures in Elderly Population?

Study Overview
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Brief Summary
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The purpose of this study is to compare if there are differences in wrist function and pain after a distal radius fracture treated conservatively with immobilization for 4 or 6 weeks in elderly patients after six months of follow-up.

Official Title
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Four or Six Weeks of Immobilization in the Conservative Treatment of Distal Radius Fractures in Elderly Population?

Conditions
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Distal Radius Fracture

Intervention / Treatment
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* Procedure: Below elbow cast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 65 years with a low energy distal radius fracture Intra or extraarticular distal radius fracture (A2, A3, C1, C2) Acceptable primary reduction (dorsal inclination <10º, radial shortening <3mm, articular gap <2mm) Exclusion criteria: History of ipsilateral fracture Bilateral fracture Open fracture Other concomitant fracture (except ulnar styloid fracture) Fracture AO B Previous surgeries in this area Dementia

Ages Eligible for Study
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Minimum Age: 65 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
Interventional Model Description: Prospective single-blinded randomised clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4 week cast<br>Patients over 65 years old with a distal radius fracture will be treated conservatively with a cast for 4 weeks. Once the immobilization will be removed, the standard rehabilitation protocol of our center used in these fractures will be carried out. The usual clinical and radiological follow-up will be performed at 3, 6 and 12 months. | Procedure: Below elbow cast<br>* Patients will be stay with a below elbow cast for 4 or 6 weeks<br>|
| Experimental: 6 week cast<br>Patients over 65 years old with a distal radius fracture will be treated conservatively with a cast for 6 weeks. Once the immobilization will be removed, the standard rehabilitation protocol of our center used in these fractures will be carried out. The usual clinical and radiological follow-up will be performed at 3, 6 and 12 months. | Procedure: Below elbow cast<br>* Patients will be stay with a below elbow cast for 4 or 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Rated Wrist Evaluation (PRWE) | The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living. | 3 months | 
| Patient Rated Wrist Evaluation (PRWE) | The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living. | 6 months | 
| Patient Rated Wrist Evaluation (PRWE) | The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick Disability of Arm and Shoulder (QuickDASH) | It is a questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. | 3 months | 
| Quick Disability of Arm and Shoulder (QuickDASH) | It is a questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. | 6 months | 
| Quick Disability of Arm and Shoulder (QuickDASH) | It is a questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale. | 1 year | 
| Visual Analogue Scale (VAS) | is a measuring instrument that tries to measure the amount of pain a patient feels, which is supposed to be a value that oscillates in a continuous between no pain and an extreme amount of pain. | 3 months | 
| Visual Analogue Scale (VAS) | is a measuring instrument that tries to measure the amount of pain a patient feels, which is supposed to be a value that oscillates in a continuous between no pain and an extreme amount of pain. | 6 months | 
| Visual Analogue Scale (VAS) | is a measuring instrument that tries to measure the amount of pain a patient feels, which is supposed to be a value that oscillates in a continuous between no pain and an extreme amount of pain. | 1 year | 
| Range Of Movement (ROM) | Flexion, Extension, radial and ulnar deviation | 3 months | 
| Range Of Movement (ROM) | Flexion, Extension, radial and ulnar deviation | 6 months | 
| Range Of Movement (ROM) | Flexion, Extension, radial and ulnar deviation | 1 year | 
| Complications | Stiffness, delayed and non-union and complex regional pain syndrome (CRPS). | 1 year |