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

NCT ID: NCT04062110

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2019-05-15

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.

Conditions

Radius Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Long plaster casts for type AO 2R3A2.2

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

Group Type: ACTIVE_COMPARATOR

plaster cast

Intervention Type: DEVICE

Closed Reduction of Fracture and Application of Plaster Cast

Short plaster casts for type AO 2R3A2.2

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

Group Type: ACTIVE_COMPARATOR

plaster cast

Intervention Type: DEVICE

Closed Reduction of Fracture and Application of Plaster Cast

Interventions

plaster cast

Closed Reduction of Fracture and Application of Plaster Cast

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital of Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gaetano Caruso, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero Universitaria di Ferrara

Locations

Azienda Ospedaliero Universitaria di Ferrara

Ferrara, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 31888682 (View on PubMed)

Other Identifiers

161184

Identifier Type: -

Identifier Source: org_study_id