Skip to main content
OpenTrials
Completed

NCT Number: NCT04062110

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Radius Fractures Arm Injuries Forearm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero Universitaria di Ferrara

Ferrara, 44124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plaster cast

Device

Closed Reduction of Fracture and Application of Plaster Cast

Primary outcomes

  1. To measure the maintenance of fracture reduction according to radial inclination (Long plaster casts Vs Short plaster casts)

    Time frame: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks

    Radial inclination: angle of the distal radial surface with respect to a line perpendicular to the shaft, a normal 16° - 18°

  2. To measure the maintenance of fracture reduction according to radial height (Long plaster casts Vs Short plaster casts)

    Time frame: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks

    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

  3. To measure the maintenance of fracture reduction according to ulnar variance (Long plaster casts Vs Short plaster casts)

    Time frame: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks

    Ulnar variance: refers to the relative lengths of the distal articular surfaces of the radius and ulna, normal -4-+2 mm

  4. To measure the maintenance of fracture reduction according to palmar tilt (Long plaster casts Vs Short plaster casts)

    Time frame: compared at baseline, at 7-10 days, at 4 weeks and at 12 weeks

    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°

Secondary outcomes

  1. Correlation RX parameters Vs functional outcomes

    Time frame: twelve weeks

    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.

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Official study title

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

Acronym: UNIFE/GC01

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 20, 2019
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.