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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03468023
Other study ID # 1165CESC
Secondary ID 1166CESC
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2017
Est. completion date March 28, 2020

Study information

Verified date September 2020
Source Azienda Ospedaliera Universitaria Integrata Verona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 353
Est. completion date March 28, 2020
Est. primary completion date February 13, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Short arm cast
Application of a below-elbow cast
Long arm cast
Application of an above-elbow cast

Locations

Country Name City State
Italy Ospedale Civile Maggiore Borgo Trento Verona

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Secondary displacement ratio Percentage of fractures that displace during treatment as subjectively assessed on radiographs by investigators. 35 days
Primary Variation of radial length Difference between radial length values as objectively measured on postreduction radiographs and endtreatment radiographs. 35 days
Primary Variation of radial inclination Difference between radial inclination values as objectively measured on postreduction radiographs and endtreatment radiographs. 35 days
Primary Variation of volar tilt Difference between volar tilt vaues as objectively measured on postreduction radiographs and endtreatment radiographs. 35 days
Secondary Post-treatment elbow range of motion (ROM) Degrees of extension, flexion, pronation and supination of the elbow measured at the end of the treatment. 35 days
Secondary DASH score Disability of Arm, Shoulder and Hand score measured at the end of the treatment relating to patient's comfort during treatment. 35 days
Secondary SF-12 Short Form 12 health questionnaire administered at the end of the treatment relating to patient's quality of life during treatment. 35 days
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