Radius FracturesUNIFE/GC01NCT04062110
Below-elbow or Above-elbow Cast for Extra-articular Distal Radius Fractures
A study testing plaster cast in people with Radius Fractures, run by University Hospital of Ferrara at 1 site in Italy.
Trial summary
The aim of this prospective randomised study was to shed more light on the issue by comparing the capacity of long plaster casts (above-elbow, LC) and short plaster casts (below-elbow, SC) to maintain the reduction of extra-articular distal radius fractures with dorsal displacement (2R3A2.2, according to the AO/OTA… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radius Fractures
- What is being tested?
- plaster cast
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2017to 15 May 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- extra-articular fractures of the distal radius with dorsal displacement (type 2R3A2.2 according to the AO classification).
- eligible for conservative treatment with plaster
Who cannot join
- open fractures
- extra-articular distal radius fracture with volar displacement
- a history of allergy to the cast material
- patients scheduled for surgical treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Below-elbow or Above-elbow Cast for Conservative Treatment of Extra-articular Distal Radius Fractures With Dorsal Displacement: a Prospective Randomized Trial
The aim of this prospective randomised study was to shed more light on the issue by comparing the capacity of long plaster casts (above-elbow, LC) and short plaster casts (below-elbow, SC) to maintain the reduction of extra-articular distal radius fractures with dorsal displacement (2R3A2.2, according to the AO/OTA classification). The initial hypothesis was that the short cast would be equally as effective as the long cast in treating this type of fracture. The secondary objective of the study was to determine whether or not there is a direct correlation between radiological parameters and functional outcomes in such patients.
Read the detailed description
Distal radial fractures are common traumatic injuries, but their management remains controversial, Hence, we conducted a two-arm, parallel-group, prospective randomised trial to compare the capacity of long casts (above-elbow) and short casts (below-elbow) to maintain the reduction of extra-articular distal radius fractures with dorsal displacement (AO/OTA classification: 2R3A2.2). Eligible patients with AO/OTA 2R3A2.2 fractures treated with closed reduction and cast immobilization were randomized to the long cast group or to the short cast group. Baseline radiological parameters, radial inclination (RI), radial height (RH), ulnar variance (UV) and palmar tilt (PT) were taken, and compared with clinical (DASH, Mayo Wrist and Mayo Elbow) and radiological scores taken at 7-10 days, 4 weeks and 12 weeks. Furthermore, to evaluate correlations between radiological parameters and functional outcomes, patients were divided into two groups according to whether or not their radiological parameters at Follow-ups 2 and 3 were acceptable, i.e. within the range 11-12 mm for RH, 16°-28° for IR, -4-+2 mm for UV, and 0°-22° for PT.
- Conditions
- Radius Fractures
- Being tested
- plaster cast
- Keywords
- distal radius fractures, above-elbow cast, below-elbow cast, conservative treatment, extra-articular fractures
- Medical subject headings
- Radius Fractures, Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plaster castDevice
Closed Reduction of Fracture and Application of Plaster Cast
| Study group | Role | What they receive |
|---|---|---|
| Long plaster casts for type AO 2R3A2.2 | Active comparator | Closed reduction of the fracture and immobilization with long plaster casts (above-elbow, Long plaster casts). Receives: Device: plaster cast |
| Short plaster casts for type AO 2R3A2.2 | Active comparator | Closed reduction of the fracture and immobilization with short plaster casts (below-elbow, Short plaster casts) Receives: Device: plaster cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the maintenance of fracture reduction according to radial inclination (Long plaster casts Vs Short plaster casts)
Radial inclination: angle of the distal radial surface with respect to a line perpendicular to the shaft, a normal 16° - 18°
Measured: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
To measure the maintenance of fracture reduction according to radial height (Long plaster casts Vs Short plaster casts)
Radial height: distance between two parallel lines drawn perpendicular to the long axis of the radial shaft, one from the tip of the radial styloid and the other from the ulnar corner of the lunate fossa, normal 11-12 mm
Measured: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
To measure the maintenance of fracture reduction according to ulnar variance (Long plaster casts Vs Short plaster casts)
Ulnar variance: refers to the relative lengths of the distal articular surfaces of the radius and ulna, normal -4-+2 mm
Measured: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
To measure the maintenance of fracture reduction according to palmar tilt (Long plaster casts Vs Short plaster casts)
Palmar tilt: can be measured by obtaining the angle of intersection between a line drawn tangentially across the most distal points of the radial articular surface and a perpendicular to the midshaft of the radius, normal 0°-22°
Measured: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
Secondary outcomes (1)
Correlation RX parameters Vs functional outcomes
To determine whether or not there is a direct correlation between radiological parameters and functional outcomes in conservatively treated patients for extra-articular distal radius fractures with dorsal displacement. The following will be used for the clinical evaluation: DASH, Mayo Wrist and Mayo Elbow scores.
Measured: twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start1 Jun 2017
- Primary completion30 Nov 2018
- Study completion15 May 2019
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 FracturesStudies 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
- two-arm, parallel-group, prospective randomised trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaetano Caruso, MD, Principal investigator, Azienda Ospedaliero Universitaria di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062110
- Sponsor's protocol ID
- 161184
- Acronym
- UNIFE/GC01
- Status last verified
- Jun 2019
- First submitted
- 21 Jun 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caruso G, Tonon F, Gildone A, Andreotti M, Altavilla R, Valentini A, Valpiani G, Massari L. Below-elbow or above-elbow cast for conservative treatment of extra-articular distal radius fractures with dorsal displacement: a prospective randomized trial. J Orthop Surg Res. 2019 Dec 30;14(1):477. doi: 10.1186/s13018-019-1530-1.
PubMed 31888682
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Below-elbow or Above-elbow Cast for Conservative Treatment of Extra-articular Distal Radius Fractures With Dorsal Displacement: a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04062110
- Acronym / sponsor ID
- UNIFE/GC01 / 161184
- Conditions
- Radius Fractures
- Keywords
- distal radius fractures, above-elbow cast, below-elbow cast, conservative treatment, extra-articular fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 20 Aug 2019 (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.
The aim of this prospective randomised study was to shed more light on the issue by comparing the capacity of long plaster casts (above-elbow, LC) and short plaster casts (below-elbow, SC) to maintain the reduction of extra-articular distal radius fractures with dorsal displacement (2R3A2.2, according to the AO/OTA classification). The initial hypothesis was that the short cast would be equally as effective as the long cast in treating this type of fracture. The secondary objective of the study was to determine whether or not there is a direct correlation between radiological parameters and functional outcomes in such patients.
Detailed description
Distal radial fractures are common traumatic injuries, but their management remains controversial, Hence, we conducted a two-arm, parallel-group, prospective randomised trial to compare the capacity of long casts (above-elbow) and short casts (below-elbow) to maintain the reduction of extra-articular distal radius fractures with dorsal displacement (AO/OTA classification: 2R3A2.2). Eligible patients with AO/OTA 2R3A2.2 fractures treated with closed reduction and cast immobilization were randomized to the long cast group or to the short cast group. Baseline radiological parameters, radial inclination (RI), radial height (RH), ulnar variance (UV) and palmar tilt (PT) were taken, and compared with clinical (DASH, Mayo Wrist and Mayo Elbow) and radiological scores taken at 7-10 days, 4 weeks and 12 weeks. Furthermore, to evaluate correlations between radiological parameters and functional outcomes, patients were divided into two groups according to whether or not their radiological parameters at Follow-ups 2 and 3 were acceptable, i.e. within the range 11-12 mm for RH, 16°-28° for IR, -4-+2 mm for UV, and 0°-22° for PT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two-arm, parallel-group, prospective randomised trial
| Arm | Type | Receives |
|---|---|---|
| Long plaster casts for type AO 2R3A2.2 | Active comparator | Device: plaster castClosed reduction of the fracture and immobilization with long plaster casts (above-elbow, Long plaster casts). |
| Short plaster casts for type AO 2R3A2.2 | Active comparator | Device: plaster castClosed reduction of the fracture and immobilization with short plaster casts (below-elbow, Short plaster casts) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- extra-articular fractures of the distal radius with dorsal displacement (type 2R3A2.2 according to the AO classification).
- eligible for conservative treatment with plaster
Key exclusion criteria (4 listed)
- open fractures
- extra-articular distal radius fracture with volar displacement
- a history of allergy to the cast material
- patients scheduled for surgical treatment
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 |
|---|---|---|
| plaster castClosed Reduction of Fracture and Application of Plaster Cast | Device | Long plaster casts for type AO 2R3A2.2, Short plaster casts for type AO 2R3A2.2 |
Primary outcome
To measure the maintenance of fracture reduction according to radial inclination (Long plaster casts Vs Short plaster casts)
Time frame: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
Radial inclination: angle of the distal radial surface with respect to a line perpendicular to the shaft, a normal 16° - 18°
To measure the maintenance of fracture reduction according to radial height (Long plaster casts Vs Short plaster casts)
Time frame: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
Radial height: distance between two parallel lines drawn perpendicular to the long axis of the radial shaft, one from the tip of the radial styloid and the other from the ulnar corner of the lunate fossa, normal 11-12 mm
To measure the maintenance of fracture reduction according to ulnar variance (Long plaster casts Vs Short plaster casts)
Time frame: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
Ulnar variance: refers to the relative lengths of the distal articular surfaces of the radius and ulna, normal -4-+2 mm
To measure the maintenance of fracture reduction according to palmar tilt (Long plaster casts Vs Short plaster casts)
Time frame: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
Palmar tilt: can be measured by obtaining the angle of intersection between a line drawn tangentially across the most distal points of the radial articular surface and a perpendicular to the midshaft of the radius, normal 0°-22°
1 secondary outcome
Correlation RX parameters Vs functional outcomes
Time frame: twelve weeks
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 20 Aug 2019.
- Derived from this study: PubMed 31888682Caruso G, Tonon F, Gildone A, Andreotti M, Altavilla R, Valentini A, Valpiani G, Massari L. Below-elbow or above-elbow cast for conservative treatment of extra-articular distal radius fractures with dorsal displacement: a prospective randomized trial. J Orthop Surg Res. 2019 Dec 30;14(1):477. doi: 10.1186/s13018-019-1530-1.
- Individual participant dataSharing planned: No
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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.
Gaetano Caruso, MD principal investigator
Azienda Ospedaliero Universitaria di Ferrara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plaster cast in people with Radius Fractures, run by University Hospital of Ferrara 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 2 inclusion and 4 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 20 Aug 2019. 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?
To measure the maintenance of fracture reduction according to radial inclination (Long plaster casts Vs Short plaster casts) (time frame: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks). 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 NCT04062110, 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 20 Aug 2019.