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NCT Number: NCT03468023

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

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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Key information

Conditions

Radius Fracture Distal Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Civile Maggiore Borgo Trento

Verona, 37126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Short arm cast

Procedure

Application of a below-elbow cast

Other names: below-elbow cast, antebrachio-metacarpal cast

Long arm cast

Procedure

Application of an above-elbow cast

Other names: above-elbow cast, brachio-metacarpal cast

Primary outcomes

  1. Secondary displacement ratio

    Time frame: 35 days

    Percentage of fractures that displace during treatment as subjectively assessed on radiographs by investigators.

  2. Variation of radial length

    Time frame: 35 days

    Difference between radial length values as objectively measured on postreduction radiographs and endtreatment radiographs.

  3. Variation of radial inclination

    Time frame: 35 days

    Difference between radial inclination values as objectively measured on postreduction radiographs and endtreatment radiographs.

  4. Variation of volar tilt

    Time frame: 35 days

    Difference between volar tilt vaues as objectively measured on postreduction radiographs and endtreatment radiographs.

Secondary outcomes

  1. Post-treatment elbow range of motion (ROM)

    Time frame: 35 days

    Degrees of extension, flexion, pronation and supination of the elbow measured at the end of the treatment.

  2. DASH score

    Time frame: 35 days

    Disability of Arm, Shoulder and Hand score measured at the end of the treatment relating to patient's comfort during treatment.

  3. SF-12

    Time frame: 35 days

    Short Form 12 health questionnaire administered at the end of the treatment relating to patient's quality of life during treatment.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Registry information

Official study 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

Acronym: SLA-Ver

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 16, 2018
Registry last updated
Sep 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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