Below-elbow or Above-elbow Cast for Extra-articular Distal Radius Fractures (UNIFE/GC01)
August 19, 2019 updated by: University Hospital of Ferrara
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ferrara, Italy, 44124
- Azienda ospedaliero Universitaria di Ferrara
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- extra-articular fractures of the distal radius with dorsal displacement (type 2R3A2.2 according to the AO classification).
- eligible for conservative treatment with plaster
Exclusion Criteria:
- open fractures
- extra-articular distal radius fracture with volar displacement
- a history of allergy to the cast material
- patients scheduled for surgical treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Long plaster casts for type AO 2R3A2.2
Closed reduction of the fracture and immobilization with long plaster casts (above-elbow, Long plaster casts).
|
Closed Reduction of Fracture and Application of Plaster Cast
|
|
Active Comparator: Short plaster casts for type AO 2R3A2.2
Closed reduction of the fracture and immobilization with short plaster casts (below-elbow, Short plaster casts)
|
Closed Reduction of Fracture and Application of Plaster Cast
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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°
|
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)
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
|
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)
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
|
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)
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°
|
compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation RX parameters Vs functional outcomes
Time Frame: twelve weeks
|
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.
|
twelve weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gaetano Caruso, MD, Azienda Ospedaliero-Universitaria di Ferrara
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2017
Primary Completion (Actual)
November 30, 2018
Study Completion (Actual)
May 15, 2019
Study Registration Dates
First Submitted
June 21, 2019
First Submitted That Met QC Criteria
August 19, 2019
First Posted (Actual)
August 20, 2019
Study Record Updates
Last Update Posted (Actual)
August 20, 2019
Last Update Submitted That Met QC Criteria
August 19, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 161184
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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