Fractures, BoneNCT03192683
Modified "Providence" Pedi Cast-Sling vs.Cast and Sling
A study testing Providence Pedi Cast-Sling and Regular sling in people with Fractures, Bone and Pediatric ALL, run by Lifespan.
Trial summary
Examining custom made sling vs. off the shelf sling for immobilization following pediatric upper extremity fractures. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Fractures, Bone, Pediatric ALL
- What is being tested?
- Providence Pedi Cast-Sling and Regular sling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 31 Dec 2016
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients aged 0-18 years old who were evaluated in the pediatric emergency department (ED) by the orthopaedic resident on call
- patients with an upper extremity fracture (wrist, forearm or elbow) that required placement of a long-arm cast.
Who cannot join
- open fractures
- fractures at multiple levels (e.g. wrist AND elbow fracture)
- fractures requiring immediate/urgent surgery
- patients requiring admission for any reason
- bivalved LAC's for any reason
About this study
Official title: Patient and Parent Satisfaction With Sling Use After Pediatric Upper Extremity Fractures: A Randomized Controlled Trial
Examining custom made sling vs. off the shelf sling for immobilization following pediatric upper extremity fractures.
- Conditions
- Fractures, Bone, Pediatric ALL
- Being tested
- Providence Pedi Cast-Sling, Regular sling
- Medical subject headings
- Fractures, Bone, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Providence Pedi Cast-SlingDevice
Custom made sling with readily available casting materials
Regular slingDevice
| Study group | Role | What they receive |
|---|---|---|
| Regular sling | Active comparator | Not described Receives: Device: Regular sling |
| Cast-sling | Experimental | Not described Receives: Device: Providence Pedi Cast-Sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction scores
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start1 Apr 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifespan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aristides Cruz, Lifespan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192683
- Sponsor's protocol ID
- 400316
- Status last verified
- Jun 2017
- First submitted
- 18 Jun 2017
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient and Parent Satisfaction With Sling Use After Pediatric Upper Extremity Fractures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03192683
- Acronym / sponsor ID
- 400316
- Conditions
- Fractures, Bone, Pediatric ALL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- LifespanUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 20 Jun 2017 (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.
Examining custom made sling vs. off the shelf sling for immobilization following pediatric upper extremity fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular sling | Active comparator | Device: Regular sling |
| Cast-sling | Experimental | Device: Providence Pedi Cast-Sling |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- patients aged 0-18 years old who were evaluated in the pediatric emergency department (ED) by the orthopaedic resident on call
- patients with an upper extremity fracture (wrist, forearm or elbow) that required placement of a long-arm cast.
Key exclusion criteria (5 listed)
- open fractures
- fractures at multiple levels (e.g. wrist AND elbow fracture)
- fractures requiring immediate/urgent surgery
- patients requiring admission for any reason
- bivalved LAC's for any reason
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 |
|---|---|---|
| Providence Pedi Cast-SlingCustom made sling with readily available casting materials | Device | Cast-sling |
| Regular sling | Device | Regular sling |
Primary outcome
Patient satisfaction scores
Time frame: 1 week
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 20 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Providence Pedi Cast-Sling and Regular sling in people with Fractures, Bone and Pediatric ALL, run by Lifespan.
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 2 inclusion and 5 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 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Patient satisfaction scores (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2017.