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

University Hospital of Ferrara

Status: Completed

Conditions: Radius Fractures

Treatments: Device: plaster cast

Study type: Interventional

Funder types: Other

Identifiers

NCT04062110

161184

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Long plaster casts for type AO 2R3A2.2

Active Comparator group

Description:

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

Treatment:

Device: plaster cast

Short plaster casts for type AO 2R3A2.2

Active Comparator group

Description:

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

Treatment:

Device: plaster cast