Fractures, ClosedCast21 SAPNCT06304649
Clinical Evaluation of Cast21 Short Arm Product During Treatment of Distal Radial or Distal Ulnar Fractures
A study testing Cast or brace alternative in people with Fractures, Closed and Fractures Bone, run by Cast21.
Trial summary
The primary objective of this study will be the collection of preliminary clinical evidence to indicate that Cast21 Short Arm Product is no worse than the current standard of care arm immobilization devices in pediatric patients. Read more about this study
- Who is it for?
- Ages 3 to 21 years
- Conditions the study is for
- Fractures, Closed, Fractures Bone, Fracture
- What is being tested?
- Cast or brace alternative
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Dec 2024
- 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 3 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Demographic characteristics: all persons ages 3 and above, regardless of the race and sex will be eligible to participate in this study
- Medical condition: participants must present with a closed, nondisplaced, or minimally displaced distal radius fracture and/or distal ulnar fracture that does not require a bone reduction procedure within 10 days from the date of injury
- Sizing: participants eligible for the Cast21 Short Arm Product must undergo sizing conducted by the clinical staff to ensure fit into one of the products (sizes XS-L)
Who cannot join
- Participants requiring a surgical intervention
- Participants with moderately displaced or angulated fractures or fractures requiring a bone reduction procedure.
- Participants with a known history of bone diseases e.g. osteogenesis imperfecta or other pathologic bone conditions
- Participants with pathologic fractures e.g., presence of bone cyst
- Participants who smoke
- Participants with pre-existing skin infection or condition of the lower arm (participants exhibiting only minor skin abrasions, lacerations, or skin condition might be eligible per clinical investigator's discretion)
About this study
The primary objective of this study will be the collection of preliminary clinical evidence to indicate that Cast21 Short Arm Product is no worse than the current standard of care arm immobilization devices in pediatric patients.
A secondary objective will be to characterize the clinician and patient experience with the Cast21 Short Arm Product.
- Conditions
- Fractures, Closed, Fractures Bone, Fracture, Fractures, Radius; Fracture, Lower or Distal End, Ulna Fractures
- Being tested
- Cast or brace alternative
- Medical subject headings
- Fractures, Closed, Fractures, Bone, Ulna Fractures, Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cast or brace alternativeDevice
Waterproof alternative to a cast or brace for broken bones
| Study group | Role | What they receive |
|---|---|---|
| Cast21 Short Arm Product | Experimental | Not described Receives: Device: Cast or brace alternative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical determination of healing (standard of care)
A binary determination of healing after the intervention will be asserted by the clinician
Measured: At treatment completion, an average of 4 weeks
Range of Motion (standard of care)
Clinicians will asses patients for a binary determination of Full Range of Motion or Limited Range of Motion
Measured: At treatment completion, an average of 4 weeks
Secondary outcomes (3)
Patient Reported Outcomes - Pain
Patient pain scores with the Wong-Baker FACES Pain Rating Scale will be assessed. The rating scale is 1 (min) to 10 (max) with lower scores being a better outcome.
Measured: Before treatment (0 Days) and at treatment completion, an average of 4 weeks
Patient Reported Outcomes - Satisfaction
A questionnaire adapted from the Patient-Reported Outcomes Measurement Information System (PROMIS) scale will be administered. The scale is 1 (min) to 5 (max), with high scores indicating a better outcome.
Measured: At treatment completion, an average of 4 weeks
Physical Therapy Referral
A binary referral to physical therapy as part of the standard of care will be observed if the patient's range of motion (see Primary Outcome 2) is such that the clinician will refer more care.
Measured: At treatment completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study startApr 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, ClosedStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cast21
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304649
- Sponsor's protocol ID
- Cast21CHLA2023Study1SAP
- Acronym
- Cast21 SAP
- Status last verified
- Mar 2024
- First submitted
- 4 Dec 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Cast21 Short Arm Product During Treatment of Distal Radial or Distal Ulnar Fractures
- ClinicalTrials.gov ID
- NCT06304649
- Acronym / sponsor ID
- Cast21 SAP / Cast21CHLA2023Study1SAP
- Conditions
- Fractures, Closed, Fractures Bone, Fracture, Fractures, Radius; Fracture, Lower or Distal End, Ulna Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cast21Industry (pharma, biotech, devices)
- Study start
- Apr 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Mar 2024 (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 primary objective of this study will be the collection of preliminary clinical evidence to indicate that Cast21 Short Arm Product is no worse than the current standard of care arm immobilization devices in pediatric patients.
A secondary objective will be to characterize the clinician and patient experience with the Cast21 Short Arm Product.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cast21 Short Arm Product | Experimental | Device: Cast or brace alternative |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Demographic characteristics: all persons ages 3 and above, regardless of the race and sex will be eligible to participate in this study
- Medical condition: participants must present with a closed, nondisplaced, or minimally displaced distal radius fracture and/or distal ulnar fracture that does not require a bone reduction procedure within 10 days from the date of injury
- Sizing: participants eligible for the Cast21 Short Arm Product must undergo sizing conducted by the clinical staff to ensure fit into one of the products (sizes XS-L)
Key exclusion criteria (6 listed)
- Participants requiring a surgical intervention
- Participants with moderately displaced or angulated fractures or fractures requiring a bone reduction procedure.
- Participants with a known history of bone diseases e.g. osteogenesis imperfecta or other pathologic bone conditions
- Participants with pathologic fractures e.g., presence of bone cyst
- Participants who smoke
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 |
|---|---|---|
| Cast or brace alternativeWaterproof alternative to a cast or brace for broken bones | Device | Cast21 Short Arm Product |
Primary outcome
Clinical determination of healing (standard of care)
Time frame: At treatment completion, an average of 4 weeks
A binary determination of healing after the intervention will be asserted by the clinician
Range of Motion (standard of care)
Time frame: At treatment completion, an average of 4 weeks
Clinicians will asses patients for a binary determination of Full Range of Motion or Limited Range of Motion
3 secondary outcomes
Patient Reported Outcomes - Pain
Time frame: Before treatment (0 Days) and at treatment completion, an average of 4 weeks
Patient Reported Outcomes - Satisfaction
Time frame: At treatment completion, an average of 4 weeks
Physical Therapy Referral
Time frame: At treatment completion, an average of 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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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 Cast or brace alternative in people with Fractures, Closed and Fractures Bone, run by Cast21.
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 6 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. 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?
Results are not available in the source record.
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?
Clinical determination of healing (standard of care) (time frame: At treatment completion, an average of 4 weeks). The study lists 2 primary outcomes in all. 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 12 Mar 2024.