Extended vs Flexed Elbow Casting

NCT03935516 | Withdrawn

• 3 other identifiers: 2017-1056SMPH\ORTHOPEDIC&REHAB\ORTHOA536110
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The study design is a prospective, randomized controlled trial comparing extended elbow and flexed elbow casting. This study design will provide the highest quality evidence to investigate our primary hypothesis that extended elbow casting for proximal both bone forearm fractures will result in less loss of fracture alignment. The study population eligible for screening will be patients with open growth plates and both bone forearm fractures.

Conditions

Fracture;Elbow

Keywords

cast; open growth plate; pediatric; both bone

Outcome Measures

Primary Outcomes (1)

• Alignment

  To compare the proportion of proximal both bone forearm fractures that have lost alignment within 6 weeks in patients treated in a flexed elbow cast compared to those treated in an extended elbow cast.

  6 weeks

Secondary Outcomes (3)

• Complication Rate

  approximately 24 weeks

• Range of Motion

  6 weeks and 24 weeks

• Caregiver Satisfaction Scores

  6 weeks

Study Arms (2)

Flexed Elbow

EXPERIMENTAL

The first group will be placed in a cast with the elbow bent.

Other: Cast

Extended Elbow

EXPERIMENTAL

The second will be placed in a cast with the elbow straight.

Other: Cast

Interventions

Cast OTHER

The use of plaster and/or fiberglass for casting of subject arm.

Extended Elbow; Flexed Elbow

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Both bone forearm fractures in which the fracture of the radius and/or ulna is located in the proximal one half of the bone
• The fracture requires a reduction maneuver
• All skeletally immature individuals under the age of 18
• Patient aged greater than three years old
• Patient or patient's consenting parent/guardian competent in English.

You may not qualify if:

• Skeletally mature individuals
• Both fractures are located in the distal one-half of the radius and ulna
• Isolated fractures of the radius or ulna
• The fracture does not require a reduction maneuver
• Any nerve or arterial injury in the injured extremity
• Humerus fracture on the ipsilateral side
• Any open fracture requiring formal surgical debridement
• Patient or patient's consenting parent/guardian not competent in English.
• Patient or patient's consenting parent/guardian not present.
• \. Severe problems with maintaining follow-up (e.g live in different state) 10. Contractures in which applying an extended elbow cast is not possible or practical

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

American Family Children's Hospital

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Elbow Fractures

Interventions

POLR1G protein, human

Condition Hierarchy (Ancestors)

Elbow 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: SPONSOR

Model Details: The study design is a prospective, randomized controlled trial comparing extended elbow and flexed elbow casting.

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: May 2, 2019
• Study Start: December 19, 2017
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: April 7, 2020

Record last verified: 2020-04

Locations

US (1)