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Below-elbow or Above-elbow Cast for Extra-articular Distal Radius Fractures (UNIFE/GC01)

Primary Purpose

Radius Fractures

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
plaster cast
Sponsored by
University Hospital of Ferrara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radius Fractures focused on measuring distal radius fractures, above-elbow cast, below-elbow cast, conservative treatment, extra-articular fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Azienda Ospedaliero Universitaria di Ferrara

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Long plaster casts for type AO 2R3A2.2

Short plaster casts for type AO 2R3A2.2

Arm Description

Closed reduction of the fracture and immobilization with long plaster casts (above-elbow, Long plaster casts).

Closed reduction of the fracture and immobilization with short plaster casts (below-elbow, Short plaster casts)

Outcomes

Primary Outcome Measures

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°
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
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
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°

Secondary Outcome Measures

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.

Full Information

First Posted
June 21, 2019
Last Updated
August 19, 2019
Sponsor
University Hospital of Ferrara
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1. Study Identification

Unique Protocol Identification Number
NCT04062110
Brief Title
Below-elbow or Above-elbow Cast for Extra-articular Distal Radius Fractures
Acronym
UNIFE/GC01
Official Title
Below-elbow or Above-elbow Cast for Conservative Treatment of Extra-articular Distal Radius Fractures With Dorsal Displacement: a Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
May 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of Ferrara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius Fractures
Keywords
distal radius fractures, above-elbow cast, below-elbow cast, conservative treatment, extra-articular fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two-arm, parallel-group, prospective randomised trial
Masking
Participant
Masking Description
randomised trial
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Long plaster casts for type AO 2R3A2.2
Arm Type
Active Comparator
Arm Description
Closed reduction of the fracture and immobilization with long plaster casts (above-elbow, Long plaster casts).
Arm Title
Short plaster casts for type AO 2R3A2.2
Arm Type
Active Comparator
Arm Description
Closed reduction of the fracture and immobilization with short plaster casts (below-elbow, Short plaster casts)
Intervention Type
Device
Intervention Name(s)
plaster cast
Intervention Description
Closed Reduction of Fracture and Application of Plaster Cast
Primary Outcome Measure Information:
Title
To measure the maintenance of fracture reduction according to radial inclination (Long plaster casts Vs Short plaster casts)
Description
Radial inclination: angle of the distal radial surface with respect to a line perpendicular to the shaft, a normal 16° - 18°
Time Frame
compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
Title
To measure the maintenance of fracture reduction according to radial height (Long plaster casts Vs Short plaster casts)
Description
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
Time Frame
compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
Title
To measure the maintenance of fracture reduction according to ulnar variance (Long plaster casts Vs Short plaster casts)
Description
Ulnar variance: refers to the relative lengths of the distal articular surfaces of the radius and ulna, normal -4-+2 mm
Time Frame
compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
Title
To measure the maintenance of fracture reduction according to palmar tilt (Long plaster casts Vs Short plaster casts)
Description
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°
Time Frame
compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
Secondary Outcome Measure Information:
Title
Correlation RX parameters Vs functional outcomes
Description
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.
Time Frame
twelve weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Caruso, MD
Organizational Affiliation
Azienda Ospedaliero Universitaria di Ferrara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliero Universitaria di Ferrara
City
Ferrara
ZIP/Postal Code
44124
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31888682
Citation
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.
Results Reference
derived

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Below-elbow or Above-elbow Cast for Extra-articular Distal Radius Fractures

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