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Short vs Long Arm Cast for Distal Radius Fractures: the Verona Trial (SLA-Ver)

Primary Purpose

Radius Fracture Distal

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Short arm cast
Long arm cast
Sponsored by
Azienda Ospedaliera Universitaria Integrata Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radius Fracture Distal focused on measuring Cast treatment, above-elbow cast, below-elbow cast, long arm cast, short arm cast

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale Civile Maggiore Borgo Trento

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Short arm cast

Long arm cast

Arm Description

Patient treated with below-elbow cast

Patients treated with above-elbow cast

Outcomes

Primary Outcome Measures

Secondary displacement ratio
Percentage of fractures that displace during treatment as subjectively assessed on radiographs by investigators.
Variation of radial length
Difference between radial length values as objectively measured on postreduction radiographs and endtreatment radiographs.
Variation of radial inclination
Difference between radial inclination values as objectively measured on postreduction radiographs and endtreatment radiographs.
Variation of volar tilt
Difference between volar tilt vaues as objectively measured on postreduction radiographs and endtreatment radiographs.

Secondary Outcome Measures

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

Full Information

First Posted
March 11, 2018
Last Updated
September 27, 2020
Sponsor
Azienda Ospedaliera Universitaria Integrata Verona
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1. Study Identification

Unique Protocol Identification Number
NCT03468023
Brief Title
Short vs Long Arm Cast for Distal Radius Fractures: the Verona Trial
Acronym
SLA-Ver
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
February 13, 2020 (Actual)
Study Completion Date
March 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Universitaria Integrata Verona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius Fracture Distal
Keywords
Cast treatment, above-elbow cast, below-elbow cast, long arm cast, short arm cast

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
353 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short arm cast
Arm Type
Experimental
Arm Description
Patient treated with below-elbow cast
Arm Title
Long arm cast
Arm Type
Active Comparator
Arm Description
Patients treated with above-elbow cast
Intervention Type
Procedure
Intervention Name(s)
Short arm cast
Other Intervention Name(s)
below-elbow cast, antebrachio-metacarpal cast
Intervention Description
Application of a below-elbow cast
Intervention Type
Procedure
Intervention Name(s)
Long arm cast
Other Intervention Name(s)
above-elbow cast, brachio-metacarpal cast
Intervention Description
Application of an above-elbow cast
Primary Outcome Measure Information:
Title
Secondary displacement ratio
Description
Percentage of fractures that displace during treatment as subjectively assessed on radiographs by investigators.
Time Frame
35 days
Title
Variation of radial length
Description
Difference between radial length values as objectively measured on postreduction radiographs and endtreatment radiographs.
Time Frame
35 days
Title
Variation of radial inclination
Description
Difference between radial inclination values as objectively measured on postreduction radiographs and endtreatment radiographs.
Time Frame
35 days
Title
Variation of volar tilt
Description
Difference between volar tilt vaues as objectively measured on postreduction radiographs and endtreatment radiographs.
Time Frame
35 days
Secondary Outcome Measure Information:
Title
Post-treatment elbow range of motion (ROM)
Description
Degrees of extension, flexion, pronation and supination of the elbow measured at the end of the treatment.
Time Frame
35 days
Title
DASH score
Description
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
Title
SF-12
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tommaso Maluta, MD
Organizational Affiliation
Azienda Ospedaliera Universitaria Integrata Verona
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Giovanni Dib, MD
Organizational Affiliation
Azienda Ospedaliera Universitaria Integrata Verona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matteo Cengarle, MD
Organizational Affiliation
Azienda Ospedaliera Universitaria Integrata Verona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alice Bernasconi, DR
Organizational Affiliation
Azienda Ospedaliera Universitaria Integrata Verona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Franco Lavini, MD
Organizational Affiliation
Azienda Ospedaliera Universitaria Integrata Verona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea Scalvi, MD
Organizational Affiliation
Azienda Ospedaliera Universitaria Integrata Verona
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bruno Magnan, MD
Organizational Affiliation
Azienda Ospedaliera Universitaria Integrata Verona
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale Civile Maggiore Borgo Trento
City
Verona
ZIP/Postal Code
37126
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
36189333
Citation
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.
Results Reference
derived

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

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