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

NCT04062110 | Completed DMC

• 1 other identifier: 161184
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Radius Fractures

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• Correlation RX parameters Vs functional outcomes

  twelve weeks

Study Arms (2)

Long plaster casts for type AO 2R3A2.2

ACTIVE COMPARATOR

Closed reduction of the fracture and immobilization with long plaster casts (above-elbow, Long plaster casts).

Device: plaster cast

Short plaster casts for type AO 2R3A2.2

ACTIVE COMPARATOR

Closed reduction of the fracture and immobilization with short plaster casts (below-elbow, Short plaster casts)

Device: plaster cast

Interventions

plaster cast DEVICE

Closed Reduction of Fracture and Application of Plaster Cast

Long plaster casts for type AO 2R3A2.2; Short plaster casts for type AO 2R3A2.2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• extra-articular fractures of the distal radius with dorsal displacement (type 2R3A2.2 according to the AO classification).
• eligible for conservative treatment with plaster

You may not qualify if:

• open fractures
• extra-articular distal radius fracture with volar displacement
• a history of allergy to the cast material
• patients scheduled for surgical treatment

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

Azienda Ospedaliero Universitaria di Ferrara

Ferrara, 44124, Italy

Location

Related Publications (1)

• 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.

  PMID: 31888682 DERIVED

MeSH Terms

Conditions

Radius Fractures; Wrist Fractures

Interventions

Casts, Surgical

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Gaetano Caruso, MD

  Azienda Ospedaliero Universitaria di Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: randomised trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two-arm, parallel-group, prospective randomised trial

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: August 20, 2019
• Study Start: June 1, 2017
• Primary Completion: November 30, 2018
• Study Completion: May 15, 2019
• Last Updated: August 20, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)