Short-Arm Casting Effective in Type A2 Fractures in the Distal Radius

NCT02286661 | Completed DMC

• 1 other identifier: T1631
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Distal radius fracture (DRF) is among the most common fractures of the long bones, which comprise one sixth of all fractures. Due to its high prevalence, effect on patients' everyday life, and cost on national health resources, its proper management is very important. The investigators performed this prospective randomized clinical trial on 100 patients with DRFs. 50 patients were treated in each group either by short or long arm cast. Patients were visited during the 6th and 18th weeks after the reduction regarding loss of reduction and possible complications.

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

• Range of Motion

  Elbow flexion-extension and forearm supination-pronation

  18 weeks after closed reduction

Secondary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  18 weeks after closed reduction and casting

Study Arms (2)

Short Arm Cast

ACTIVE COMPARATOR

Short arm cast below the elbow

Procedure: Casting (short arm)

Long Arm Cast

ACTIVE COMPARATOR

Long arm cast above the elbow

Procedure: Casting (long arm)

Interventions

Casting (long arm) PROCEDURE

Casting using plaster of paris after closed reduction of distal radius fracture

Long Arm Cast

Casting (short arm) PROCEDURE

Short Arm Cast

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 20 years
• Type A2 according to the AO classification
• Closed distal radial physis
• Initial radiographic evidence of extra articular DRF
• With at least one non-comminuted cortex

You may not qualify if:

• Fractures with dorsal angulations of more than 20 degrees
• Radial shortening of more than 10 millimeters
• Extensive cortical comminution as unstable fractures
• Patients with unstable fractures
• Existence of multiple fractures or open fracture in the affected limb or other limbs
• Cerebral palsy
• Paresthesia of the affected limb due to the pervious cerebro-vascular accidents
• Previous severe deformity of the affected limb diabetes
• Severe osteoporosis
• Less than two consecutive follow-up visits

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 10, 2014
• Study Start: September 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: November 10, 2014

Record last verified: 2014-11