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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

353 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-15

Study Completion Date

2020-03-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Radius Fracture Distal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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%.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Short arm cast

Patient treated with below-elbow cast

Group Type EXPERIMENTAL

Short arm cast

Intervention Type PROCEDURE

Application of a below-elbow cast

Long arm cast

Patients treated with above-elbow cast

Group Type ACTIVE_COMPARATOR

Long arm cast

Intervention Type PROCEDURE

Application of an above-elbow cast

Interventions

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Short arm cast

Application of a below-elbow cast

Intervention Type PROCEDURE

Long arm cast

Application of an above-elbow cast

Intervention Type PROCEDURE

Other Intervention Names

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below-elbow cast antebrachio-metacarpal cast above-elbow cast brachio-metacarpal cast

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Tommaso Maluta

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR