Radius Fractures Clinical Trial
— UNIFE/GC01Official title:
Below-elbow or Above-elbow Cast for Conservative Treatment of Extra-articular Distal Radius Fractures With Dorsal Displacement: a Prospective Randomized Trial
NCT number | NCT04062110 |
Other study ID # | 161184 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2017 |
Est. completion date | May 15, 2019 |
Verified date | June 2019 |
Source | University Hospital of Ferrara |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliero Universitaria di Ferrara | Ferrara |
Lead Sponsor | Collaborator |
---|---|
University Hospital of Ferrara |
Italy,
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 |
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