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

Radius Fractures Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04062110
• Other study ID #: 161184
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Fractures, Bone
• Radius Fractures

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