Short vs Long Arm Cast for Distal Radius Fractures: the Verona Trial

Study Overview
=================
Brief Summary
-----------------
This study prospectively compares the performance of an above-elbow cast (long arm cast) and a below-elbow cast (short arm cast) to maintain reduction in conservatively managed distal radius fractures.

Detailed Description
-----------------
The choice of cast length in conservative management of distal radius fractures still represents a much debated controversy. Classic teaching was to immobilize the elbow to reduce risk of secondary displacement; however, short arm casts are felt to be equally effective with less complications and higher patient comfort. There is currently no conclusive evidence for or against immobilization of the elbow in patients treated with cast immobilization.

Official Title
-----------------
Short vs Long Arm Cast for Distal Radius Fractures: the Verona Trial. Randomized Clinical Trial to Assess the Efficacy of Short Arm Cast Versus Long Arm Cast in Conservative Management of Distal Radius Fractures

Conditions
-----------------
Radius Fracture Distal

Intervention / Treatment
-----------------
* Procedure: Short arm cast
* Procedure: Long arm cast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of distal radius fracture Indication to conservative treatment Need for manipulation to reduce fracture Exclusion Criteria: Open fractures Existence of any skin lesion or wound that would impair cast treatment Neurovascular deficits Bilateral fractures Association with any other fracture of the homolateral arm

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-inferiority trial aimed at comparing the non inferiority of a short arm cast (below elbow cast) as opposed to a long arm cast (below elbow cast) in terms of fracture reduction maintenance ratio. The sample size was selected as the highest required to test all non-inferiority thresholds and considering a drop-out percentage of 15%. Continuous values of all radiological parameters were used in order to keep results objective and reproducible. At the end of recruitment observed drop-out percentage was 26%.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short arm cast<br>Patient treated with below-elbow cast | Procedure: Short arm cast<br>* Application of a below-elbow cast<br>* Other names: antebrachio-metacarpal cast;|
| Active Comparator: Long arm cast<br>Patients treated with above-elbow cast | Procedure: Long arm cast<br>* Application of an above-elbow cast<br>* Other names: brachio-metacarpal cast;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary displacement ratio | Percentage of fractures that displace during treatment as subjectively assessed on radiographs by investigators. | 35 days | 
| Variation of radial length | Difference between radial length values as objectively measured on postreduction radiographs and endtreatment radiographs. | 35 days | 
| Variation of radial inclination | Difference between radial inclination values as objectively measured on postreduction radiographs and endtreatment radiographs. | 35 days | 
| Variation of volar tilt | Difference between volar tilt vaues as objectively measured on postreduction radiographs and endtreatment radiographs. | 35 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-treatment elbow range of motion (ROM) | Degrees of extension, flexion, pronation and supination of the elbow measured at the end of the treatment. | 35 days | 
| DASH score | Disability of Arm, Shoulder and Hand score measured at the end of the treatment relating to patient's comfort during treatment. | 35 days | 
| SF-12 | Short Form 12 health questionnaire administered at the end of the treatment relating to patient's quality of life during treatment. | 35 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cast treatment, above-elbow cast, below-elbow cast, long arm cast, short arm cast