Distal Radius FracturesPhase 4NCT00610220
Cast Versus Splint in Children With Acceptably Angulated Wrist Fractures
A Phase 4 study testing Fiberglass short arm cast and Prefabricated wrist splint in people with Distal Radius Fractures, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The study will compare the effectiveness of a prefabricated wrist splint with thermoplast reinforcements versus a short arm cast in skeletally immature children. The hypothesis is that the commercially available wrist splint is at least as effective as traditional casting with respect to recovery of physical function. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- Fiberglass short arm cast and Prefabricated wrist splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2007to Oct 2009
- Phase
- Phase 4
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Skeletally immature children.
- Children must have a bone age of ≥ 5 years of age.
- Less than or equal to 15° angulation in the sagittal plane and ≤ 0.5 cm displacement in the frontal plane.
- Therefore, all skeletally immature children ≥ 5 years and with a bone age of ≤ 11 years who present to the ED of HSC with acute distal metaphyseal radius +/- ulnar fractures that meet criteria for acceptable angulation and displacement will be eligible for enrollment.
Who cannot join
- Age < 5 years or > 12
- The following diagnoses of distal radius fracture: buckle fracture, growth plate fractures of any kind, distal radius metaphyseal fractures with greater than 15° of angulation in the sagittal plane and/or more than 0.5 cm of displacement in the frontal plane.
- All open fractures which require a surgical debridement.
- All children at risk for pathological fractures such as those with congenital or acquired generalized bony disease. Stricter immobilization and a different prognosis may be applicable to this population.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cast Versus Splint in Children With Minimally Angulated Fractures of the Distal Radius: a Randomized Controlled Trial.
The study will compare the effectiveness of a prefabricated wrist splint with thermoplast reinforcements versus a short arm cast in skeletally immature children.
The hypothesis is that the commercially available wrist splint is at least as effective as traditional casting with respect to recovery of physical function.
Read the detailed description
Acceptability angulated wrist bone fractures in children carry an excellent long-term prognosis because of the unique capacity of skeletally immature bones to heal via remodeling. Their management varies widely and there is virtually no scientific evidence supporting one treatment modality over another. Importantly, the most common treatment modality of cast application for four to six weeks is associated with many inconveniences. There are commercially available wrist splints that offer a more convenient alternative. Wrist splints likely have comparable immobilization and symptom relief, while simultaneously allowing for easier bathing and less reliance on subspeciality care. Preliminary adult evidence suggests that, in a comparable adult fracture, splinting may offer a safe alternative to casting, with earlier resumption of the usual activities. However, this treatment modality needs to be compared to the traditional casting management in the pediatric population before it can be recommended for clinical practice.
This study will be the first to challenge the current practice of routine casting and compare it to a commercially available wrist splint with respect to recovery of physical function in children with acceptably angulated wrist fractures. In addition, standardized treatment of these fractures with a splint may be associated with lower morbidity, reduced use of health care resources, and have the potential for cost savings.
This study will compare, in skeletally immature children, the functional outcomes that result from treatment with a prefabricated wrist splint versus a short arm cast in acceptably angulated distal radius fractures. Secondly, the cost-effectiveness of the splint relative to the cast will be evaluated.
- Conditions
- Distal Radius Fractures
- Being tested
- Fiberglass short arm cast, Prefabricated wrist splint
- Keywords
- pediatrics, wrist fractures, casting, wrist splint
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiberglass short arm castDevice
Cast will be applied for a 4-week period
Prefabricated wrist splintDevice
Splint will be applied for a 4-week period
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Device: Fiberglass short arm cast |
| 2 | Experimental | Not described Receives: Device: Prefabricated wrist splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified performance Activities Scale for Kids (ASKp) score
Measured: 6 weeks
Secondary outcomes (6)
Changes in Angulation and/or displacement
Measured: 1 and 4 weeks
Pain
Measured: 1 and 4 weeks
Duration of immobilization device
Measured: 1 and 4 week follow-up visits
Grip Strength
Measured: 6 week follow-up visit
Range of Motion
Measured: Week 6
Patient Preference for their Device
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startJan 2007
- Primary completionJul 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathy Boutis, The Hospital for Sick Children
- Investigators
- Kathy Boutis, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610220
- Sponsor's protocol ID
- 1000010377
- Status last verified
- May 2014
- First submitted
- 24 Jan 2008
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boutis K, Willan A, Babyn P, Goeree R, Howard A. Cast versus splint in children with minimally angulated fractures of the distal radius: a randomized controlled trial. CMAJ. 2010 Oct 5;182(14):1507-12. doi: 10.1503/cmaj.100119. Epub 2010 Sep 7.
PubMed 20823169
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cast Versus Splint in Children With Minimally Angulated Fractures of the Distal Radius: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00610220
- Acronym / sponsor ID
- 1000010377
- Conditions
- Distal Radius Fractures
- Keywords
- pediatrics, wrist fractures, casting, wrist splint
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 7 Feb 2008 (estimated)
- 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 study will compare the effectiveness of a prefabricated wrist splint with thermoplast reinforcements versus a short arm cast in skeletally immature children.
The hypothesis is that the commercially available wrist splint is at least as effective as traditional casting with respect to recovery of physical function.
Detailed description
Acceptability angulated wrist bone fractures in children carry an excellent long-term prognosis because of the unique capacity of skeletally immature bones to heal via remodeling. Their management varies widely and there is virtually no scientific evidence supporting one treatment modality over another. Importantly, the most common treatment modality of cast application for four to six weeks is associated with many inconveniences. There are commercially available wrist splints that offer a more convenient alternative. Wrist splints likely have comparable immobilization and symptom relief, while simultaneously allowing for easier bathing and less reliance on subspeciality care. Preliminary adult evidence suggests that, in a comparable adult fracture, splinting may offer a safe alternative to casting, with earlier resumption of the usual activities. However, this treatment modality needs to be compared to the traditional casting management in the pediatric population before it can be recommended for clinical practice.
This study will be the first to challenge the current practice of routine casting and compare it to a commercially available wrist splint with respect to recovery of physical function in children with acceptably angulated wrist fractures. In addition, standardized treatment of these fractures with a splint may be associated with lower morbidity, reduced use of health care resources, and have the potential for cost savings.
This study will compare, in skeletally immature children, the functional outcomes that result from treatment with a prefabricated wrist splint versus a short arm cast in acceptably angulated distal radius fractures. Secondly, the cost-effectiveness of the splint relative to the cast will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Fiberglass short arm cast |
| 2 | Experimental | Device: Prefabricated wrist splint |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Skeletally immature children.
- Children must have a bone age of ≥ 5 years of age.
- Less than or equal to 15° angulation in the sagittal plane and ≤ 0.5 cm displacement in the frontal plane.
- Therefore, all skeletally immature children ≥ 5 years and with a bone age of ≤ 11 years who present to the ED of HSC with acute distal metaphyseal radius +/- ulnar fractures that meet criteria for acceptable angulation and displacement will be eligible for enrollment.
Key exclusion criteria (4 listed)
- Age < 5 years or > 12
- The following diagnoses of distal radius fracture: buckle fracture, growth plate fractures of any kind, distal radius metaphyseal fractures with greater than 15° of angulation in the sagittal plane and/or more than 0.5 cm of displacement in the frontal plane.
- All open fractures which require a surgical debridement.
- All children at risk for pathological fractures such as those with congenital or acquired generalized bony disease. Stricter immobilization and a different prognosis may be applicable to this population.
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 |
|---|---|---|
| Fiberglass short arm castCast will be applied for a 4-week period | Device | 1 |
| Prefabricated wrist splintSplint will be applied for a 4-week period | Device | 2 |
Primary outcome
Modified performance Activities Scale for Kids (ASKp) score
Time frame: 6 weeks
6 secondary outcomes
Changes in Angulation and/or displacement
Time frame: 1 and 4 weeks
Pain
Time frame: 1 and 4 weeks
Duration of immobilization device
Time frame: 1 and 4 week follow-up visits
Grip Strength
Time frame: 6 week follow-up visit
Range of Motion
Time frame: Week 6
Patient Preference for their Device
Time frame: Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Results publication: PubMed 20823169Boutis K, Willan A, Babyn P, Goeree R, Howard A. Cast versus splint in children with minimally angulated fractures of the distal radius: a randomized controlled trial. CMAJ. 2010 Oct 5;182(14):1507-12. doi: 10.1503/cmaj.100119. Epub 2010 Sep 7.
Related trials for Distal Radius Fractures
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Not yet recruiting
One Inch Punch High Impact Training Randomized Control Trial (1'' Punch HIT RCT)
Distal Radius Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
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.
Kathy Boutis, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fiberglass short arm cast and Prefabricated wrist splint in people with Distal Radius Fractures, run by The Hospital for Sick Children at 1 site in Canada.
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 4 inclusion and 4 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 9 Oct 2017. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Modified performance Activities Scale for Kids (ASKp) score (time frame: 6 weeks). 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 NCT00610220, which also lists 1 linked publication.
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 9 Oct 2017.