Trial Outcomes & Findings for Randomized Trial of Casting Techniques for Displaced Forearm Fractures (NCT NCT00823823)

NCT ID: NCT00823823

Last Updated: 2014-09-09

Results Overview

The number of participants that experienced radiographic loss of reduction by four weeks post-randomization.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 202 participants
• Primary outcome timeframe: 4 weeks post-randomization
• Results posted on: 2014-09-09

Participant Flow

Participant milestones

Measure	Bivalved Cast Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast	Circumferential Cast Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
Overall Study STARTED	109	107
Overall Study COMPLETED	101	101
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Measure	Bivalved Cast Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast	Circumferential Cast Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
Overall Study Lost to Follow-up	3	1
Overall Study Protocol Violation	5	5

Baseline Characteristics

Randomized Trial of Casting Techniques for Displaced Forearm Fractures

Baseline characteristics by cohort

Measure	Bivalved Cast n=101 Participants Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast	Circumferential Cast n=101 Participants Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast	Total n=202 Participants Total of all reporting groups
Age, Categorical <=18 years	101 Participants n=93 Participants	101 Participants n=4 Participants	202 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	9 years STANDARD_DEVIATION 6 • n=93 Participants	10 years STANDARD_DEVIATION 6 • n=4 Participants	10 years STANDARD_DEVIATION 3 • n=27 Participants
Sex: Female, Male Female	34 Participants n=93 Participants	33 Participants n=4 Participants	67 Participants n=27 Participants
Sex: Female, Male Male	67 Participants n=93 Participants	68 Participants n=4 Participants	135 Participants n=27 Participants
Region of Enrollment United States	101 participants n=93 Participants	101 participants n=4 Participants	202 participants n=27 Participants

PRIMARY outcome

Timeframe: 4 weeks post-randomization

Population: All subjects who completed the four-week follow-up period with no protocol violations.

The number of participants that experienced radiographic loss of reduction by four weeks post-randomization.

Outcome measures

Measure	Bivalved Cast n=101 Participants Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast	Circumferential Cast n=101 Participants Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
Loss of Radius Fracture Reduction Loss of reduction	35 participants	35 participants
Loss of Radius Fracture Reduction No Loss of reduction	66 participants	66 participants

SECONDARY outcome

Timeframe: Up to 4 weeks post-randomization

Population: All subjects who completed the four-week follow-up period with no protocol violations.

The number of participants that experienced compartment syndrome or neurovascular compromise, saw burn and/or laceration within four weeks post-randomization.

Outcome measures

Measure	Bivalved Cast n=101 Participants Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast	Circumferential Cast n=101 Participants Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations Compartment syndrome	0 participants	0 participants
Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations Cast saw burn	0 participants	0 participants
Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations Laceration	0 participants	0 participants
Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations Infection	0 participants	0 participants

Adverse Events

Bivalved Cast

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Circumferential Cast

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Bivalved Cast n=109 participants at risk Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast	Circumferential Cast n=107 participants at risk Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
Injury, poisoning and procedural complications Cast saw burn	0.92% 1/109 • Number of events 1 • Approximately 6 weeks (from time of ED visit to last clinical follow-up visit)	0.00% 0/107 • Approximately 6 weeks (from time of ED visit to last clinical follow-up visit)

Additional Information

Dr. Donald Bae

Children's Hospital Boston

Phone: 617-355-6808

Email: donald.bae@childrens.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place