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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04062110
Other study ID # 161184
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2017
Est. completion date May 15, 2019

Study information

Verified date June 2019
Source University Hospital of Ferrara
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date May 15, 2019
Est. primary completion date November 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
plaster cast
Closed Reduction of Fracture and Application of Plaster Cast

Locations

Country Name City State
Italy Azienda Ospedaliero Universitaria di Ferrara Ferrara

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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° compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
Primary 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 compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
Primary 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 compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
Primary 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° compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
Secondary 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. twelve weeks
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