Fracture of Shaft of Radius and/or UlnaNCT02614690

Is Univalving or Bivalving of Long Arm Casts for Forearm Fractures Necessary?

A study testing No Split Cast of forearm fractures, Univalve Split Cast of forearm fractures and Bivalve Split Cast of forearm fractures in people with Fracture of Shaft of Radius and/or Ulna and Metaphyseal Fracture of Bone of Upper Limb, run by Connecticut Children's Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to examine the need for univalve or bivalve splitting of casts in pediatric patients with forearm fractures following closed reduction and cast application in a randomized, prospective fashion. Read more about this study

Who is it for?: Ages 3 to 12 years
Conditions the study is for: Fracture of Shaft of Radius and/or Ulna, Metaphyseal Fracture of Bone of Upper Limb, Fracture of Upper Limb, Level Unspecified
What is being tested?: No Split Cast of forearm fractures, Univalve Split Cast of forearm fractures and Bivalve Split Cast of forearm fractures
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Jan 2013to Dec 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

A closed isolated radial and/or ulna fracture of the forearm inclusive of metaphyseal and/or shaft level fractures.
Forearm fractures that require closed reduction (with or without conscious sedation)
Patients between the ages of 3 and 12 years old

Who cannot join

Specific exclusions
Age less than 3 or greater than 12
Patients presenting with an associated neurological or vascular injury caused by the fracture
Patients presenting with an open fracture
Patients requiring operative treatment following the initial fracture evaluation
Ipsilateral upper extremity fracture
Patients intubated or with a pre-existing condition that prevents them from verbalizing symptoms of discomfort
Generic exclusion: "Subjects not meeting all inclusion criteria."

Trial locations and contacts

1 site in 1 country.

United States1 site

Connecticut Children's Medical Center
Hartford, Connecticut, 06016

Other trials in United States

About this study

Read the detailed description

Following cast application, little is known regarding the need to split the cast, either in a univalve (a split along a single side of the cast) or bivalve (a split along both sides of the cast) fashion. Theoretically, the splitting of the cast allows for expansion and soft tissue swelling. However, review of the literature yields a paucity of evidence demonstrating the efficacy of splitting a cast. In a study by Nietosvaara et. al, a retrospective examination of 109 pediatric patients initially treated with closed cylindrical casting for closed forearm fractures were evaluated. Of these 109 patients, one-sixth required the initial cast to be split, trimmed, or removed secondary to post-traumatic swelling.

However, the splitting of a cast is not without risks in itself. Once the initial swelling dissipates, a univalved or bivalved cast can become excessively loose. This loosening has been associated with a loss of reduction. If the loss or reduction is substantial, it may require a re-reduction or operation to correct. In addition, with every use of the cast saw a patient is placed at risk for iatrogenic cast saw injury. Thermal burns and abrasions from cast saws can cause lifelong emotional and physical scars for a patient. They can also be an inciting event for litigation against the hospital and or provider, with settlements averaging greater than $12,000 per centimeter of cast saw injury.

Conditions: Fracture of Shaft of Radius and/or Ulna, Metaphyseal Fracture of Bone of Upper Limb, Fracture of Upper Limb, Level Unspecified
Being tested: No Split Cast of forearm fractures, Univalve Split Cast of forearm fractures, Bivalve Split Cast of forearm fractures
Keywords: Fracture of the upper limb

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No Split Cast of forearm fracturesProcedure or surgery
Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to "No Split Cast" will have a cast that is not split, this is known as closed cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months.
Univalve Split Cast of forearm fracturesProcedure or surgery
Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to "Univalve Cast" will have a cast that is split on only one side of the cast, this is known as univalve cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months.
Bivalve Split Cast of forearm fracturesProcedure or surgery
Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to "Bivalve Cast" will have a cast that is split on both sides of the cast, this is known as bivalve cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months.

Study groups in NCT02614690
Study group	Role	What they receive
No split Cast of forearm fractures	Active comparator	Patient will have a "No split cast" long arm cast applied after a closed reduction of forearm fractures. The cast will not be split. 20 patients will be randomized to this arm. Receives: Procedure: No Split Cast of forearm fractures
Univalve Split Cast of forearm fractures	Active comparator	Patients will have a "Univalve Split Cast" long arm cast applied after undergoing closed reduction of of forearm fractures. This is a cast that is split on only one side of the cast. 20 patients will be randomized to this arm Receives: Procedure: Univalve Split Cast of forearm fractures
Bivalve Split Cast of forearm fractures	Active comparator	Patients will have a "Bivalve Split Cast" long arm cast applied after they have undergone a closed reduction of of forearm fractures. This is a cast that will be split on both sides of the cast. 20 patients will be randomized to the bivalve split arm cast. Receives: Procedure: Bivalve Split Cast of forearm fractures

What is being measured

The primary outcome is the main question the study is designed to answer.

Complication Rate of the Cast Type
This data will be able to help physicians and ER personnel help this patient population with the least number of cast complications and therefore allow for a more efficient use of resources since cast modifications could be minimized. Metrics used to characterize complications are the radiographic union used to determine speed of healing and the number of unplanned ER or clinic visits for cast modifications.
Measured: <60 days corresponding to total study time and consistent with outcome 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Dec 2015

First posted25 Nov 2015 (estimated)
Study startJan 2013
Primary completionSep 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Fracture of Shaft of Radius and/or UlnaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02614690
Sponsor's protocol ID: SRC118
Status last verified: Jan 2022
First submitted: 26 May 2015
Last updated: 14 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Not sharing individual data. Plan is to publish the data.

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Is Univalving or Bivalving of Long Arm Casts for Forearm Fractures Necessary?
ClinicalTrials.gov ID: NCT02614690
Acronym / sponsor ID: SRC118
Conditions: Fracture of Shaft of Radius and/or Ulna, Metaphyseal Fracture of Bone of Upper Limb, Fracture of Upper Limb, Level Unspecified
Keywords: Fracture of the upper limb
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Connecticut Children's Medical CenterUniversity, hospital or other
Study start: Jan 2013
Primary completion: Sep 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 25 Nov 2015 (estimated)
Results: Posted 28 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
No split Cast of forearm fractures	Active comparator	Procedure: No Split Cast of forearm fracturesPatient will have a "No split cast" long arm cast applied after a closed reduction of forearm fractures. The cast will not be split. 20 patients will be randomized to this arm.
Univalve Split Cast of forearm fractures	Active comparator	Procedure: Univalve Split Cast of forearm fracturesPatients will have a "Univalve Split Cast" long arm cast applied after undergoing closed reduction of of forearm fractures. This is a cast that is split on only one side of the cast. 20 patients will be randomized to this arm
Bivalve Split Cast of forearm fractures	Active comparator	Procedure: Bivalve Split Cast of forearm fracturesPatients will have a "Bivalve Split Cast" long arm cast applied after they have undergone a closed reduction of of forearm fractures. This is a cast that will be split on both sides of the cast. 20 patients will be randomized to the bivalve split arm cast.

Who may qualify

Ages: 3 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

A closed isolated radial and/or ulna fracture of the forearm inclusive of metaphyseal and/or shaft level fractures.
Forearm fractures that require closed reduction (with or without conscious sedation)
Patients between the ages of 3 and 12 years old

Key exclusion criteria (8 listed)

Specific exclusions
Generic exclusion: "Subjects not meeting all inclusion criteria."

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No Split Cast of forearm fracturesEnroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to "No Split Cast" will have a cast that is not split, this is known as closed cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months.	Procedure or surgery	No split Cast of forearm fractures
Univalve Split Cast of forearm fracturesEnroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to "Univalve Cast" will have a cast that is split on only one side of the cast, this is known as univalve cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months.	Procedure or surgery	Univalve Split Cast of forearm fractures
Bivalve Split Cast of forearm fracturesEnroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to "Bivalve Cast" will have a cast that is split on both sides of the cast, this is known as bivalve cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months.	Procedure or surgery	Bivalve Split Cast of forearm fractures

Primary outcome

Complication Rate of the Cast Type
Time frame: <60 days corresponding to total study time and consistent with outcome 6
This data will be able to help physicians and ER personnel help this patient population with the least number of cast complications and therefore allow for a more efficient use of resources since cast modifications could be minimized. Metrics used to characterize complications are the radiographic union used to determine speed of healing and the number of unplanned ER or clinic visits for cast modifications.

Results and safety

Results posted to the registry on 28 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
No Split Cast of Forearm Fractures	20	20
Univalve Split Cast of Forearm Fractures	20	20
Bivalve Split Cast of Forearm Fractures	20	20

Primary outcome: Complication Rate of the Cast Type

Time frame: <60 days corresponding to total study time and consistent with outcome 6. Number. Unit: participants

Measure	No Split Cast of Forearm Fractures n = 20	Univalve Split Cast of Forearm Fractures n = 20	Bivalve Split Cast of Forearm Fractures n = 20
Value	9	12	8

Adverse events

Time frame: Adverse Events were collected 5 to 10 days, and 6 weeks after the initial cast application. Also captured at visit that occurred at the discretion of the provider.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Split Cast of Forearm Fractures	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Univalve Split Cast of Forearm Fractures	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Bivalve Split Cast of Forearm Fractures	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Limitations and caveats (from the sponsor): The study was powered to detect a two patient difference in the incidence of cast related compartment syndrome and neurologic injuries between the three casting groups.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Not sharing individual data. Plan is to publish the data.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Lee, MD principal investigator

Connecticut Children's Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complication Rate of the Cast Type (time frame: <60 days corresponding to total study time and consistent with outcome 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02614690.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.