Clinical trial NCT03468023: Short vs Long Arm Cast for Distal Radius Fractures: the Verona Trial
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
Overall status: COMPLETED
Phase: NA
Conditions: Radius Fracture Distal
Keywords: Cast treatment
above-elbow cast
below-elbow cast
long arm cast
short arm cast
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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%.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Secondary displacement ratio
timeFrame: 35 days
measure: Variation of radial length
timeFrame: 35 days
measure: Variation of radial inclination
timeFrame: 35 days
measure: Variation of volar tilt
timeFrame: 35 days
Secondary outcomes:
measure: Post-treatment elbow range of motion (ROM)
timeFrame: 35 days
measure: DASH score
timeFrame: 35 days
measure: SF-12
timeFrame: 35 days
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Ospedale Civile Maggiore Borgo Trento
Study officials:
affiliation: Azienda Ospedaliera Universitaria Integrata Verona
name: Tommaso Maluta, MD
role: STUDY_DIRECTOR
affiliation: Azienda Ospedaliera Universitaria Integrata Verona
name: Giovanni Dib, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera Universitaria Integrata Verona
name: Matteo Cengarle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera Universitaria Integrata Verona
name: Alice Bernasconi, DR
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera Universitaria Integrata Verona
name: Franco Lavini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliera Universitaria Integrata Verona
name: Andrea Scalvi, MD
role: STUDY_CHAIR
affiliation: Azienda Ospedaliera Universitaria Integrata Verona
name: Bruno Magnan, MD
role: STUDY_CHAIR
References:
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.