Closed Fracture of Shaft of UlnaLASTNCT03724773
Long-Arm vs Sugar-Tong
A study testing Long-Arm Cast and Sugar-Tong Splint in people with Closed Fracture of Shaft of Ulna and Closed Fracture of Shaft of Radius, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a sugar-tong splint is as effective as a long-arm cast in maintaining reduction of pediatric forearm shaft fractures in a randomized, prospective manner. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Closed Fracture of Shaft of Ulna, Closed Fracture of Shaft of Radius
- What is being tested?
- Long-Arm Cast and Sugar-Tong Splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2019to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Single or both bone forearm shaft fractures, follow-up at the St. Louis Children's Hospital and affiliated branches
Who cannot join
- Children below 4 or above 12 years of age
- Distal radius/ulna fracture(s)
- Distal radius/ulna third shaft fracture(s)
- Proximal radius/ulna third shaft fracture(s)
- Radius/ulna fracture(s) not requiring reduction
- Open radius/ulna fracture(s)
Show all 10Show fewer
- Radius/ulna fracture(s) requiring open reduction in the operating room
- Patient with metabolic defects
- Pathologic radius/ulna fracture(s)
- Previous fractures in the same location (radius/ulna)
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: Outcomes of Long-Arm Casting Versus Sugar-Tong Splinting of Displaced Forearm Shaft Fractures
The purpose of this study is to determine whether a sugar-tong splint is as effective as a long-arm cast in maintaining reduction of pediatric forearm shaft fractures in a randomized, prospective manner. Consented participants will be randomly assigned to be treated with either a sugar-tong splint or a long-arm cast (both standard of care treatments) in REDCap. Each participant will have a 50/50 chance of being assign to either treatment.
Read the detailed description
Forearm fractures are very common in the pediatric population and can often be treated with closed reduction and immobilization. Immobilization techniques include long-arm casting, short-arm casting and sugar-tong splinting. At the time of injury casts are usually split into two using a cast saw, known as bivalving, to allow for swelling and are overwrapped at a later time. By design sugar-tong splints allow for swelling and are overwrapped or converted to a cast at a later time. Traditionally long-arm casts have been used as the standard mode of immobilization for forearm fractures. Recent evidence demonstrates that long-arm casting is equivalent to better tolerated short-arm casting as an immobilization choice for distal third forearm fractures.1 Further work has shown that sugar-tong splints are also appropriate for treatment of distal third forearm fractures. No study has compared the efficacy of using a long-arm cast versus a sugar-tong splint for treatment of forearm shaft fractures.
- Being tested
- Long-Arm Cast, Sugar-Tong Splint
- Keywords
- Closed Reduction, Sugar-Tong Splint, Long-Arm Cast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-Arm CastDevice
A long-arm cast is a circumferential wrapping of the arm from the fingers to above the elbow with casting material.
Sugar-Tong SplintDevice
A sugar-tong splint is the application of hard splinting material on the front and back of the arm.
| Study group | Role | What they receive |
|---|---|---|
| Long-Arm Cast | Active comparator | Reduction and long-arm cast application will be performed by PGY-1 and up residents with adequate training and/or supervision in the required techniques. Receives: Device: Long-Arm Cast |
| Sugar-Tong Splint | Active comparator | Reduction and sugar-tong splint application will be performed by PGY-1 and up residents with adequate training and/or supervision in the required techniques. Receives: Device: Sugar-Tong Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic measurements
Measure sagittal angulation
Measured: 1 week
Radiographic measurements
Measure sagittal angulation
Measured: 2 weeks
Radiographic measurements
Measure sagittal angulation
Measured: 4 weeks
Radiographic measurements
Measure sagittal angulation
Measured: 6 weeks
Radiographic measurements
Coronal angulation
Measured: 1 week
Radiographic measurements
Coronal angulation
Measured: 2 weeks
Radiographic measurements
Coronal angulation
Measured: 4 weeks
Radiographic measurements
Coronal angulation
Measured: 6 weeks
Radiographic measurements
Displacement
Measured: 1 week
Radiographic measurements
Displacement
Measured: 2 weeks
Radiographic measurements
Displacement
Measured: 4 weeks
Radiographic measurements
Displacement
Measured: 6 weeks
Radiographic measurements
Percent displacement
Measured: 1 week
Radiographic measurements
Percent displacement
Measured: 2 weeks
Radiographic measurements
Percent displacement
Measured: 4 weeks
Radiographic measurements
Percent displacement
Measured: 6 weeks
Secondary outcomes (4)
Clinical follow-up
Treatment information
Measured: 1 week
Clinical follow-up
Treatment information
Measured: 2 weeks
Clinical follow-up
Treatment information
Measured: 4 weeks
Clinical follow-up
Treatment information
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study startMar 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionSep 2020 (estimated)
Why it stopped: Decided not to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Closed Fracture of Shaft of UlnaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724773
- Sponsor's protocol ID
- 201807196
- Acronym
- LAST
- Status last verified
- Oct 2019
- First submitted
- 22 Oct 2018
- Last updated
- 24 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Bohm ER, Bubbar V, Yong Hing K, Dzus A. Above and below-the-elbow plaster casts for distal forearm fractures in children. A randomized controlled trial. J Bone Joint Surg Am. 2006 Jan;88(1):1-8. doi: 10.2106/JBJS.E.00320.
PubMed 16391243Levy J, Ernat J, Song D, Cook JB, Judd D, Shaha S. Outcomes of long-arm casting versus double-sugar-tong splinting of acute pediatric distal forearm fractures. J Pediatr Orthop. 2015 Jan;35(1):11-7. doi: 10.1097/BPO.0000000000000196.
PubMed 24787302Kamat AS, Pierse N, Devane P, Mutimer J, Horne G. Redefining the cast index: the optimum technique to reduce redisplacement in pediatric distal forearm fractures. J Pediatr Orthop. 2012 Dec;32(8):787-91. doi: 10.1097/BPO.0b013e318272474d.
PubMed 23147621Alemdaroglu KB, Iltar S, Cimen O, Uysal M, Alagoz E, Atlihan D. Risk factors in redisplacement of distal radial fractures in children. J Bone Joint Surg Am. 2008 Jun;90(6):1224-30. doi: 10.2106/JBJS.G.00624.
PubMed 18519314
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Long-Arm Casting Versus Sugar-Tong Splinting of Displaced Forearm Shaft Fractures
- ClinicalTrials.gov ID
- NCT03724773
- Acronym / sponsor ID
- LAST / 201807196
- Keywords
- Closed Reduction, Sugar-Tong Splint, Long-Arm Cast
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decided not to enroll
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 30 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a sugar-tong splint is as effective as a long-arm cast in maintaining reduction of pediatric forearm shaft fractures in a randomized, prospective manner. Consented participants will be randomly assigned to be treated with either a sugar-tong splint or a long-arm cast (both standard of care treatments) in REDCap. Each participant will have a 50/50 chance of being assign to either treatment.
Detailed description
Forearm fractures are very common in the pediatric population and can often be treated with closed reduction and immobilization. Immobilization techniques include long-arm casting, short-arm casting and sugar-tong splinting. At the time of injury casts are usually split into two using a cast saw, known as bivalving, to allow for swelling and are overwrapped at a later time. By design sugar-tong splints allow for swelling and are overwrapped or converted to a cast at a later time. Traditionally long-arm casts have been used as the standard mode of immobilization for forearm fractures. Recent evidence demonstrates that long-arm casting is equivalent to better tolerated short-arm casting as an immobilization choice for distal third forearm fractures.1 Further work has shown that sugar-tong splints are also appropriate for treatment of distal third forearm fractures. No study has compared the efficacy of using a long-arm cast versus a sugar-tong splint for treatment of forearm shaft fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long-Arm Cast | Active comparator | Device: Long-Arm CastReduction and long-arm cast application will be performed by PGY-1 and up residents with adequate training and/or supervision in the required techniques. |
| Sugar-Tong Splint | Active comparator | Device: Sugar-Tong SplintReduction and sugar-tong splint application will be performed by PGY-1 and up residents with adequate training and/or supervision in the required techniques. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Single or both bone forearm shaft fractures, follow-up at the St. Louis Children's Hospital and affiliated branches
Key exclusion criteria (10 listed)
- Children below 4 or above 12 years of age
- Distal radius/ulna fracture(s)
- Distal radius/ulna third shaft fracture(s)
- Proximal radius/ulna third shaft fracture(s)
- Radius/ulna fracture(s) not requiring reduction
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 |
|---|---|---|
| Long-Arm CastA long-arm cast is a circumferential wrapping of the arm from the fingers to above the elbow with casting material. | Device | Long-Arm Cast |
| Sugar-Tong SplintA sugar-tong splint is the application of hard splinting material on the front and back of the arm. | Device | Sugar-Tong Splint |
Primary outcome
Radiographic measurements
Time frame: 1 week
Measure sagittal angulation
Radiographic measurements
Time frame: 2 weeks
Measure sagittal angulation
Radiographic measurements
Time frame: 4 weeks
Measure sagittal angulation
Radiographic measurements
Time frame: 6 weeks
Measure sagittal angulation
Radiographic measurements
Time frame: 1 week
Coronal angulation
Radiographic measurements
Time frame: 2 weeks
Coronal angulation
Radiographic measurements
Time frame: 4 weeks
Coronal angulation
Radiographic measurements
Time frame: 6 weeks
Coronal angulation
Radiographic measurements
Time frame: 1 week
Displacement
Radiographic measurements
Time frame: 2 weeks
Displacement
Radiographic measurements
Time frame: 4 weeks
Displacement
Radiographic measurements
Time frame: 6 weeks
Displacement
Radiographic measurements
Time frame: 1 week
Percent displacement
Radiographic measurements
Time frame: 2 weeks
Percent displacement
Radiographic measurements
Time frame: 4 weeks
Percent displacement
Radiographic measurements
Time frame: 6 weeks
Percent displacement
4 secondary outcomes
Clinical follow-up
Time frame: 1 week
Clinical follow-up
Time frame: 2 weeks
Clinical follow-up
Time frame: 4 weeks
Clinical follow-up
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2019.
- Background: PubMed 16391243Bohm ER, Bubbar V, Yong Hing K, Dzus A. Above and below-the-elbow plaster casts for distal forearm fractures in children. A randomized controlled trial. J Bone Joint Surg Am. 2006 Jan;88(1):1-8. doi: 10.2106/JBJS.E.00320.
- Background: PubMed 24787302Levy J, Ernat J, Song D, Cook JB, Judd D, Shaha S. Outcomes of long-arm casting versus double-sugar-tong splinting of acute pediatric distal forearm fractures. J Pediatr Orthop. 2015 Jan;35(1):11-7. doi: 10.1097/BPO.0000000000000196.
- Background: PubMed 23147621Kamat AS, Pierse N, Devane P, Mutimer J, Horne G. Redefining the cast index: the optimum technique to reduce redisplacement in pediatric distal forearm fractures. J Pediatr Orthop. 2012 Dec;32(8):787-91. doi: 10.1097/BPO.0b013e318272474d.
- Background: PubMed 18519314Alemdaroglu KB, Iltar S, Cimen O, Uysal M, Alagoz E, Atlihan D. Risk factors in redisplacement of distal radial fractures in children. J Bone Joint Surg Am. 2008 Jun;90(6):1224-30. doi: 10.2106/JBJS.G.00624.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long-Arm Cast and Sugar-Tong Splint in people with Closed Fracture of Shaft of Ulna and Closed Fracture of Shaft of Radius, run by Washington University School of Medicine at 1 site in United States.
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 1 inclusion and 10 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: withdrawn, as of the sponsor's last update on 24 Oct 2019. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Radiographic measurements (time frame: 1 week). The study lists 16 primary outcomes in all. 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 NCT03724773, which also lists 4 linked publications.
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 24 Oct 2019.