NCT03468023

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
353

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2020

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

2.9 years

First QC Date

March 11, 2018

Last Update Submit

September 27, 2020

Conditions

Radius Fracture Distal

Keywords

Cast treatmentabove-elbow castbelow-elbow castlong arm castshort arm cast

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • Post-treatment elbow range of motion (ROM)

    35 days

  • DASH score

    35 days

  • SF-12

    35 days

Study Arms (2)

Short arm cast

EXPERIMENTAL

Patient treated with below-elbow cast

Procedure: Short arm cast

Long arm cast

ACTIVE COMPARATOR

Patients treated with above-elbow cast

Procedure: Long arm cast

Interventions

Short arm castPROCEDURE

Application of a below-elbow cast

Also known as: below-elbow cast, antebrachio-metacarpal cast
Short arm cast
Long arm castPROCEDURE

Application of an above-elbow cast

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Civile Maggiore Borgo Trento

Verona, 37126, Italy

Location

Related Publications (1)

  • 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.

    PMID: 36189333DERIVED

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Tommaso Maluta, MD

    Azienda Ospedaliera Universitaria Integrata Verona

    STUDY DIRECTOR

  • Giovanni Dib, MD

    Azienda Ospedaliera Universitaria Integrata Verona

    PRINCIPAL INVESTIGATOR

  • Matteo Cengarle, MD

    Azienda Ospedaliera Universitaria Integrata Verona

    PRINCIPAL INVESTIGATOR

  • Alice Bernasconi, DR

    Azienda Ospedaliera Universitaria Integrata Verona

    PRINCIPAL INVESTIGATOR

  • Franco Lavini, MD

    Azienda Ospedaliera Universitaria Integrata Verona

    PRINCIPAL INVESTIGATOR

  • Andrea Scalvi, MD

    Azienda Ospedaliera Universitaria Integrata Verona

    STUDY CHAIR

  • Bruno Magnan, MD

    Azienda Ospedaliera Universitaria Integrata Verona

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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%.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 11, 2018

First Posted

March 16, 2018

Study Start

March 15, 2017

Primary Completion

February 13, 2020

Study Completion

March 28, 2020

Last Updated

September 29, 2020

Record last verified: 2020-09

Locations

IT(1)