Radius Fracture DistalSLA-VerNCT03468023
Short vs Long Arm Cast for Distal Radius Fractures: the Verona Trial
A study testing Short arm cast and Long arm cast in people with Radius Fracture Distal, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radius Fracture Distal
- What is being tested?
- Short arm cast and Long arm cast
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2017to 28 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of distal radius fracture
- Indication to conservative treatment
- Need for manipulation to reduce fracture
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Radius Fracture Distal
- Being tested
- Short arm cast, Long arm cast
- Keywords
- Cast treatment, above-elbow cast, below-elbow cast, long arm cast, short arm cast
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short arm castProcedure or surgery
Also called below-elbow cast, antebrachio-metacarpal cast
Application of a below-elbow cast
Long arm castProcedure or surgery
Also called above-elbow cast, brachio-metacarpal cast
Application of an above-elbow cast
| Study group | Role | What they receive |
|---|---|---|
| Short arm cast | Experimental | Patient treated with below-elbow cast Receives: Procedure: Short arm cast |
| Long arm cast | Active comparator | Patients treated with above-elbow cast Receives: Procedure: Long arm cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary displacement ratio
Percentage of fractures that displace during treatment as subjectively assessed on radiographs by investigators.
Measured: 35 days
Variation of radial length
Difference between radial length values as objectively measured on postreduction radiographs and endtreatment radiographs.
Measured: 35 days
Variation of radial inclination
Difference between radial inclination values as objectively measured on postreduction radiographs and endtreatment radiographs.
Measured: 35 days
Variation of volar tilt
Difference between volar tilt vaues as objectively measured on postreduction radiographs and endtreatment radiographs.
Measured: 35 days
Secondary outcomes (3)
Post-treatment elbow range of motion (ROM)
Degrees of extension, flexion, pronation and supination of the elbow measured at the end of the treatment.
Measured: 35 days
DASH score
Disability of Arm, Shoulder and Hand score measured at the end of the treatment relating to patient's comfort during treatment.
Measured: 35 days
SF-12
Short Form 12 health questionnaire administered at the end of the treatment relating to patient's quality of life during treatment.
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start15 Mar 2017
- Primary completion13 Feb 2020
- Study completion28 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radius Fracture DistalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tommaso Maluta, Azienda Ospedaliera Universitaria Integrata Verona
- Investigators
- Tommaso Maluta, MD, Study director, Azienda Ospedaliera Universitaria Integrata VeronaGiovanni Dib, MD, Principal investigator, Azienda Ospedaliera Universitaria Integrata VeronaMatteo Cengarle, MD, Principal investigator, Azienda Ospedaliera Universitaria Integrata VeronaAlice Bernasconi, DR, Principal investigator, Azienda Ospedaliera Universitaria Integrata VeronaFranco Lavini, MD, Principal investigator, Azienda Ospedaliera Universitaria Integrata VeronaAndrea Scalvi, MD, Study chair, Azienda Ospedaliera Universitaria Integrata VeronaBruno Magnan, MD, Study chair, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468023
- Sponsor's protocol ID
- 1165CESC
- Other IDs
- 1166CESC
- Acronym
- SLA-Ver
- Status last verified
- Sep 2020
- First submitted
- 11 Mar 2018
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03468023
- Acronym / sponsor ID
- SLA-Ver / 1165CESC
- Conditions
- Radius Fracture Distal
- Keywords
- Cast treatment, above-elbow cast, below-elbow cast, long arm cast, short arm cast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 13 Feb 2020 (actual)
- Study completion
- 28 Mar 2020 (actual)
- First posted
- 16 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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%.
| Arm | Type | Receives |
|---|---|---|
| Short arm cast | Experimental | Procedure: Short arm castPatient treated with below-elbow cast |
| Long arm cast | Active comparator | Procedure: Long arm castPatients treated with above-elbow cast |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of distal radius fracture
- Indication to conservative treatment
- Need for manipulation to reduce fracture
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short arm castAlso: below-elbow cast, antebrachio-metacarpal castApplication of a below-elbow cast | Procedure or surgery | Short arm cast |
| Long arm castAlso: above-elbow cast, brachio-metacarpal castApplication of an above-elbow cast | Procedure or surgery | Long arm cast |
Primary outcome
Secondary displacement ratio
Time frame: 35 days
Percentage of fractures that displace during treatment as subjectively assessed on radiographs by investigators.
Variation of radial length
Time frame: 35 days
Difference between radial length values as objectively measured on postreduction radiographs and endtreatment radiographs.
Variation of radial inclination
Time frame: 35 days
Difference between radial inclination values as objectively measured on postreduction radiographs and endtreatment radiographs.
Variation of volar tilt
Time frame: 35 days
Difference between volar tilt vaues as objectively measured on postreduction radiographs and endtreatment radiographs.
3 secondary outcomes
Post-treatment elbow range of motion (ROM)
Time frame: 35 days
DASH score
Time frame: 35 days
SF-12
Time frame: 35 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Derived from this study: PubMed 36189333Dib 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short arm cast and Long arm cast in people with Radius Fracture Distal, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Secondary displacement ratio (time frame: 35 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03468023, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.