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CompletedNCT03468023SLA-VerUpdated Sep 29, 2020

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

An interventional study of Short arm cast and Long arm cast in Radius Fracture Distal, sponsored by Azienda Ospedaliera Universitaria Integrata Verona. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-29.

Sponsored by Azienda Ospedaliera Universitaria Integrata Verona · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Mar 2017, registered Mar 2018).

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Phase
Not applicable
Study type
Interventional
Enrollment
353
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Radius Fracture Distal

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Keywords

  • Cast treatment
  • above-elbow cast
  • below-elbow cast
  • long arm cast
  • short arm cast
03

In context

Wrist Fractures

330 studies on the registry are indexed under Wrist Fractures; 72 are open to participants now.

This study's enrollment of 353 is above the median of 63 across 265 interventional studies indexed under Wrist Fractures.

Browse Wrist Fractures studies →

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona is the lead sponsor of 95 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of distal radius fracture
  • Indication to conservative treatment
  • Need for manipulation to reduce fracture

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
353 participants (actual)

Study arms

  • Experimental
    Short arm cast

    Patient treated with below-elbow cast

    Procedure: Short arm cast

  • Active comparator
    Long arm cast

    Patients treated with above-elbow cast

    Procedure: Long arm cast

Interventions

  • ProcedureShort arm cast

    Application of a below-elbow cast

    Also known as: below-elbow cast, antebrachio-metacarpal cast

  • ProcedureLong arm cast

    Application of an above-elbow cast

    Also known as: above-elbow cast, brachio-metacarpal cast

06

What researchers measure

Primary outcomes

  1. Secondary displacement ratio

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

    Time frame: 35 days

  2. Variation of radial length

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

    Time frame: 35 days

  3. Variation of radial inclination

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

    Time frame: 35 days

  4. Variation of volar tilt

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

    Time frame: 35 days

Secondary outcomes

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

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

    Time frame: 35 days

  2. DASH score

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

    Time frame: 35 days

  3. SF-12

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

    Time frame: 35 days

07

Study locations

1 site
  • Ospedale Civile Maggiore Borgo Trento
    Verona, 37126, Italy
08

References and documents

Publications

  • Dib G, Maluta T, Cengarle M, Bernasconi A, Marconato G, Corain M, Magnan B. Short arm cast is as effective as long arm cast in maintaining distal radius fracture reduction: Results of the SLA-VER noninferiority trial. World J Orthop. 2022 Sep 18;13(9):802-811. doi: 10.5312/wjo.v13.i9.802. eCollection 2022 Sep 18. PubMed 36189333 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2017 to primary completion in Feb 2020, 34 months.

Of 126 non-industry interventional studies with no phase under Wrist Fractures, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's 34 months is above that.

Counting every sponsor, half of 127 studies reached it within 25 months; a quarter within 16 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 11, 2018
First posted
Mar 16, 2018
StartActual
Mar 15, 2017
Primary completionActual
Feb 13, 2020
CompletionActual
Mar 28, 2020
Last update
Sep 29, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03468023
Lead sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Responsible party
Tommaso Maluta (Principal Investigator, Azienda Ospedaliera Universitaria Integrata Verona) — Principal investigator
First posted
Mar 16, 2018
Start date
Mar 15, 2017
Primary completion
Feb 13, 2020
Completion
Mar 28, 2020
Last update
Sep 29, 2020

Study contacts

Tommaso Maluta, MD
study director · Azienda Ospedaliera Universitaria Integrata Verona
Giovanni Dib, MD
principal investigator · Azienda Ospedaliera Universitaria Integrata Verona
Matteo Cengarle, MD
principal investigator · Azienda Ospedaliera Universitaria Integrata Verona
Alice Bernasconi, DR
principal investigator · Azienda Ospedaliera Universitaria Integrata Verona
Franco Lavini, MD
principal investigator · Azienda Ospedaliera Universitaria Integrata Verona
Andrea Scalvi, MD
study chair · Azienda Ospedaliera Universitaria Integrata Verona
Bruno Magnan, MD
study chair · Azienda Ospedaliera Universitaria Integrata Verona

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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