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

Below-elbow or Above-elbow Cast for Conservative Treatment of Extra-articular Distal Radius Fractures With Dorsal Displacement: a Prospective Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04062110
Acronym
UNIFE/GC01
Enrollment
74
Registered
2019-08-20
Start date
2017-06-01
Completion date
2019-05-15
Last updated
2019-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radius Fractures

Keywords

distal radius fractures, above-elbow cast, below-elbow cast, conservative treatment, extra-articular fractures

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.

Interventions

Closed Reduction of Fracture and Application of Plaster Cast

Sponsors

University Hospital of Ferrara
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

randomised trial

Intervention model description

two-arm, parallel-group, prospective randomised trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
To measure the maintenance of fracture reduction according to ulnar variance (Long plaster casts Vs Short plaster casts)compared at baseline, at 7-10 days, at 4 weeks and at 12 weeksUlnar 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 radial inclination (Long plaster casts Vs Short plaster casts)compared at baseline, at 7-10 days, at 4 weeks and at 12 weeksRadial 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)compared at baseline, at 7-10 days, at 4 weeks and at 12 weeksRadial 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 palmar tilt (Long plaster casts Vs Short plaster casts)compared at baseline, at 7-10 days, at 4 weeks and at 12 weeksPalmar 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

MeasureTime frameDescription
Correlation RX parameters Vs functional outcomestwelve weeksTo 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026