An interventional study of plaster cast in Radius Fractures, sponsored by University Hospital of Ferrara. Completed at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-20.
Sponsored by University Hospital of Ferrara · Not applicable, Interventional, and Treatment
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.
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 74 is close to the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →University Hospital of Ferrara is the lead sponsor of 110 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
Closed reduction of the fracture and immobilization with long plaster casts (above-elbow, Long plaster casts).
Device: plaster cast
Closed reduction of the fracture and immobilization with short plaster casts (below-elbow, Short plaster casts)
Device: plaster cast
Closed Reduction of Fracture and Application of Plaster Cast
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°
Time frame: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
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
Time frame: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
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
Time frame: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
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°
Time frame: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks
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.
Time frame: twelve weeks
Plan to share: No
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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University Hospital of Ferrara