Clinical trial NCT04062110: Below-elbow or Above-elbow Cast for Extra-articular Distal Radius Fractures
Official title: Below-elbow or Above-elbow Cast for Conservative Treatment of Extra-articular Distal Radius Fractures With Dorsal Displacement: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radius Fractures
Keywords: distal radius fractures
above-elbow cast
below-elbow cast
conservative treatment
extra-articular fractures
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two-arm, parallel-group, prospective randomised trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To measure the maintenance of fracture reduction according to radial inclination (Long plaster casts Vs Short plaster casts)
timeFrame: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
measure: To measure the maintenance of fracture reduction according to radial height (Long plaster casts Vs Short plaster casts)
timeFrame: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
measure: To measure the maintenance of fracture reduction according to ulnar variance (Long plaster casts Vs Short plaster casts)
timeFrame: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
measure: To measure the maintenance of fracture reduction according to palmar tilt (Long plaster casts Vs Short plaster casts)
timeFrame: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
Secondary outcomes:
measure: Correlation RX parameters Vs functional outcomes
timeFrame: twelve weeks
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Azienda Ospedaliero Universitaria di Ferrara
Study officials:
affiliation: Azienda Ospedaliero Universitaria di Ferrara
name: Gaetano Caruso, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.