Forearm Fractures (Both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft)CRABB-YNCT06799377
Complications Related To Activity After Pediatric Both Bone Fractures: Exploring the Effects of Activity on Fracture Displacement
A study testing Restricted Activity Reccomendations and Full Activity/Limited Activity Reccomendations in people with Forearm Fractures (Both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft), run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The goal of this randomized clinical study is to understand the effect of activity on the re-displacement of pediatric forearm fractures in patients ages 8-18 years old excluding those with known metabolic bone disease or obvious refracture. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Forearm Fractures (Both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft)
- What is being tested?
- Restricted Activity Reccomendations and Full Activity/Limited Activity Reccomendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2025to 1 Aug 2028
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Isolated Distal Radius Metaphyseal Fx (with or without ulna styloid)
- Distal Third (<4 cm from physis) Radius and Ulna fracture (i.e. without obvious physeal involvement)
- Insolated Radial Shaft Fracture (diaphyseal)
- Radial and Ulna Shaft Fracture (diaphyseal)
Who cannot join
- Initial presentation >7 days from the time of injury
- Pathologic fracture
- Any patient with metabolic bone disease (ex. Osteoporosis, skeletal dysplasias)
- Any patient with known bone fragility condition (ex. Osteogenesis imperfecta)
- If operative treatment is required at initial presentation
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Children's Hospital Orthopedics Clinic
Nashville, Tennessee, 37232
About this study
Official title: Complications Related to Activity After Both Bone Fractures: Why do we Restrict Activity?
The goal of this randomized clinical study is to understand the effect of activity on the re-displacement of pediatric forearm fractures in patients ages 8-18 years old excluding those with known metabolic bone disease or obvious refracture. The main questions the study aims to answer are:
Does increased activity lead to increased re-displacement rates during the treatment of pediatric forearm fractures? Are there complications associated with increased levels of activity during the treatment of pediatric forearm fractures (skin irritation, need for re-casting, operation)? Do activity restrictions provided for pediatric forearm fractures influence patient activity levels?
Participants will be randomized into activity-restricted vs activity-limited (no contact sports). Some patients will be provided an ActiGraph Activity tracker to monitor patient activity. Every patient will complete a validated activity survey (PAQ) to assess activity at each follow-up appointment. Activity data and any complications will be recorded from time of initial presentation to cast removal.
- Conditions
- Forearm Fractures (Both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft)
- Being tested
- Restricted Activity Reccomendations, Full Activity/Limited Activity Reccomendations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restricted Activity ReccomendationsBehavioural
Patients in this respective group will be given restricted activity recommendations over the casting period. They will be told "Your child has a forearm/wrist fracture. It is unknown if remaining active while in a cast affects the risk of complications after this type of fracture. Your child has been randomized to the "restricted activity" group. We ask that you limit sprinting, jumping, and organized sports during the time of cast immobilization. As a rule of thumb, we recommend "feet on the floor" activities while playing and avoiding playgrounds and gym class if possible. While it is not realistic to restrict a young child entirely, do your best to avoid strenuous or intense exercise until cleared by your physician or nurse practitioner"
Full Activity/Limited Activity ReccomendationsBehavioural
Patients in this respective group will be allowed to engage in most activities. They will be read "Your child has a forearm/wrist fracture. It is unknown if remaining active while in a cast affects the risk of complications after this type of fracture. Your child has been randomized to the "activity as tolerated" group. Your child may participate in all desired activities except contact sports. Your child does not need to increase his/her activity level but should participate in activities as they feel comfortable doing so. Sprinting, jumping, and organized sports are acceptable as long as your child is not experiencing pain. Your child may use playgrounds and participate in gym class as desired. Do your best to avoid restricting your child from activities unless they are experiencing pain or you have concerns about their safety."
| Study group | Role | What they receive |
|---|---|---|
| Restricted Activity Group | Active comparator | This group of patients will be given restricted activity recommendations. They will be told: "Your child has a forearm/wrist fracture. It is unknown if remaining active while in a cast affects the risk of complications after this type of fracture. Your child has been randomized to the "restricted activity" group. We ask that you limit sprinting, jumping, and organized sports during the time of cast immobilization. As a rule of thumb, we recommend "feet on the floor" activities while playing and avoiding playgrounds and gym class if possible. While it is not realistic to restrict a young child entirely, do your best to avoid strenuous or intense exercise until cleared by your physician or nurse practitioner" Receives: Behavioral: Restricted Activity Reccomendations |
| Activity (Limited) Group | Active comparator | This group of patients will be given limited activity recommendations. They will be told "Your child has a forearm/wrist fracture. It is unknown if remaining active while in a cast affects the risk of complications after this type of fracture. Your child has been randomized to the "activity as tolerated" group. Your child may participate in all desired activities except contact sports. Your child does not need to increase his/her activity level but should participate in activities as they feel comfortable doing so. Sprinting, jumping, and organized sports are acceptable as long as your child is not experiencing pain. Your child may use playgrounds and participate in gym class as desired. Do your best to avoid restricting your child from activities unless they are experiencing pain or you have concerns about their safety." Receives: Behavioral: Full Activity/Limited Activity Reccomendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-Displacement
Re-displacement will be defined as a change in angulation of greater than 10 degrees.
Measured: From Cast Placement to Cast Removal, aproximately 6-8 weeks.
Secondary outcomes (3)
Complications
The rate of complications including skin irritation/breakdown, the need for re-casting, and the need for operative management.
Measured: From casting to cast removal, approximately 6-8 weeks.
Activity Level as measured by patient-completed validated activity surveys (PAQ)
Activity levels based on patient-completed validated activity surveys (PAQ)
Measured: Time of clinic presentation to cast removal, approximately 6-8 weeks.
Activity Level as measured by patient-worn activity trackers
Activity levels based on patient-worn activity trackers
Measured: Time of clinic presentation to cast removal, approximately 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start16 Jan 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Why it stopped: Funding for software licensing is no longer available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Forearm Fractures (Both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft)Studies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Model description
- Randomized Clinical Trial with two group that receive different activity restrictions
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathaniel Lempert, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799377
- Sponsor's protocol ID
- 241179
- Acronym
- CRABB-Y
- Status last verified
- Sep 2026
- First submitted
- 16 Jan 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We do not plan to submit to International Committee of Medical Journal Editors (ICMJE)
Publications
Alagoz E, Gulec MA. Factors affecting re-displacement in pediatric forearm fractures and the role of cast indices. Jt Dis Relat Surg. 2020;31(1):95-101. doi: 10.5606/ehc.2020.71523.
PubMed 32160501Ting BL, Kalish LA, Waters PM, Bae DS. Reducing Cost and Radiation Exposure During the Treatment of Pediatric Greenstick Fractures of the Forearm. J Pediatr Orthop. 2016 Dec;36(8):816-820. doi: 10.1097/BPO.0000000000000560.
PubMed 26057068Sara Peiffer, Samuel J. Dressler, William L. Hennrikus; Outcomes of Displaced Forearm Fractures in Children Treated With Closed Reduction and Casting and a Loop and Sling Attached to the Cast Proximal to the Fracture Site. Pediatrics March 2021; 147 (3_MeetingAbstract): 798. 10.1542/peds.147.3MA8.798a
Sengab A, Krijnen P, Schipper IB. Displaced distal radius fractures in children, cast alone vs additional K-wire fixation: a meta-analysis. Eur J Trauma Emerg Surg. 2019 Dec;45(6):1003-1011. doi: 10.1007/s00068-018-1011-y. Epub 2018 Oct 1.
PubMed 30276723Knopp BW, Harris M. Pediatric Forearm Fracture Characteristics as Prognostic Indicators of Healing. Cureus. 2023 Feb 7;15(2):e34741. doi: 10.7759/cureus.34741. eCollection 2023 Feb.
PubMed 36913227
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications Related to Activity After Both Bone Fractures: Why do we Restrict Activity?
- ClinicalTrials.gov ID
- NCT06799377
- Acronym / sponsor ID
- CRABB-Y / 241179
- Conditions
- Forearm Fractures (Both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft)
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Funding for software licensing is no longer available.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 29 Jan 2025 (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 goal of this randomized clinical study is to understand the effect of activity on the re-displacement of pediatric forearm fractures in patients ages 8-18 years old excluding those with known metabolic bone disease or obvious refracture. The main questions the study aims to answer are:
Does increased activity lead to increased re-displacement rates during the treatment of pediatric forearm fractures? Are there complications associated with increased levels of activity during the treatment of pediatric forearm fractures (skin irritation, need for re-casting, operation)? Do activity restrictions provided for pediatric forearm fractures influence patient activity levels?
Participants will be randomized into activity-restricted vs activity-limited (no contact sports). Some patients will be provided an ActiGraph Activity tracker to monitor patient activity. Every patient will complete a validated activity survey (PAQ) to assess activity at each follow-up appointment. Activity data and any complications will be recorded from time of initial presentation to cast removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial with two group that receive different activity restrictions
| Arm | Type | Receives |
|---|---|---|
| Restricted Activity Group | Active comparator | Behavioral: Restricted Activity ReccomendationsThis group of patients will be given restricted activity recommendations. They will be told: "Your child has a forearm/wrist fracture. It is unknown if remaining active while in a cast affects the risk of complications after this type of fracture. Your child has been randomized to the "restricted activity" group. We ask that you limit sprinting, jumping, and organized sports during the time of cast immobilization. As a rule of thumb, we recommend "feet on the floor" activities while playing and avoiding playgrounds and gym class if possible. While it is not realistic to restrict a young child entirely, do your best to avoid strenuous or intense exercise until cleared by your physician or nurse practitioner" |
| Activity (Limited) Group | Active comparator | Behavioral: Full Activity/Limited Activity ReccomendationsThis group of patients will be given limited activity recommendations. They will be told "Your child has a forearm/wrist fracture. It is unknown if remaining active while in a cast affects the risk of complications after this type of fracture. Your child has been randomized to the "activity as tolerated" group. Your child may participate in all desired activities except contact sports. Your child does not need to increase his/her activity level but should participate in activities as they feel comfortable doing so. Sprinting, jumping, and organized sports are acceptable as long as your child is not experiencing pain. Your child may use playgrounds and participate in gym class as desired. Do your best to avoid restricting your child from activities unless they are experiencing pain or you have concerns about their safety." |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Isolated Distal Radius Metaphyseal Fx (with or without ulna styloid)
- Distal Third (<4 cm from physis) Radius and Ulna fracture (i.e. without obvious physeal involvement)
- Insolated Radial Shaft Fracture (diaphyseal)
- Radial and Ulna Shaft Fracture (diaphyseal)
Key exclusion criteria (5 listed)
- Initial presentation >7 days from the time of injury
- Pathologic fracture
- Any patient with metabolic bone disease (ex. Osteoporosis, skeletal dysplasias)
- Any patient with known bone fragility condition (ex. Osteogenesis imperfecta)
- If operative treatment is required at initial presentation
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 |
|---|---|---|
| Restricted Activity ReccomendationsPatients in this respective group will be given restricted activity recommendations over the casting period. They will be told "Your child has a forearm/wrist fracture. It is unknown if remaining active while in a cast affects the risk of complications after this type of fracture. Your child has been randomized to the "restricted activity" group. We ask that you limit sprinting, jumping, and organized sports during the time of cast immobilization. As a rule of thumb, we recommend "feet on the floor" activities while playing and avoiding playgrounds and gym class if possible. While it is not realistic to restrict a young child entirely, do your best to avoid strenuous or intense exercise until cleared by your physician or nurse practitioner" | Behavioural | Restricted Activity Group |
| Full Activity/Limited Activity ReccomendationsPatients in this respective group will be allowed to engage in most activities. They will be read "Your child has a forearm/wrist fracture. It is unknown if remaining active while in a cast affects the risk of complications after this type of fracture. Your child has been randomized to the "activity as tolerated" group. Your child may participate in all desired activities except contact sports. Your child does not need to increase his/her activity level but should participate in activities as they feel comfortable doing so. Sprinting, jumping, and organized sports are acceptable as long as your child is not experiencing pain. Your child may use playgrounds and participate in gym class as desired. Do your best to avoid restricting your child from activities unless they are experiencing pain or you have concerns about their safety." | Behavioural | Activity (Limited) Group |
Primary outcome
Re-Displacement
Time frame: From Cast Placement to Cast Removal, aproximately 6-8 weeks.
Re-displacement will be defined as a change in angulation of greater than 10 degrees.
3 secondary outcomes
Complications
Time frame: From casting to cast removal, approximately 6-8 weeks.
Activity Level as measured by patient-completed validated activity surveys (PAQ)
Time frame: Time of clinic presentation to cast removal, approximately 6-8 weeks.
Activity Level as measured by patient-worn activity trackers
Time frame: Time of clinic presentation to cast removal, approximately 6-8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 32160501Alagoz E, Gulec MA. Factors affecting re-displacement in pediatric forearm fractures and the role of cast indices. Jt Dis Relat Surg. 2020;31(1):95-101. doi: 10.5606/ehc.2020.71523.
- Background: PubMed 26057068Ting BL, Kalish LA, Waters PM, Bae DS. Reducing Cost and Radiation Exposure During the Treatment of Pediatric Greenstick Fractures of the Forearm. J Pediatr Orthop. 2016 Dec;36(8):816-820. doi: 10.1097/BPO.0000000000000560.
- BackgroundSara Peiffer, Samuel J. Dressler, William L. Hennrikus; Outcomes of Displaced Forearm Fractures in Children Treated With Closed Reduction and Casting and a Loop and Sling Attached to the Cast Proximal to the Fracture Site. Pediatrics March 2021; 147 (3_MeetingAbstract): 798. 10.1542/peds.147.3MA8.798a
- Background: PubMed 30276723Sengab A, Krijnen P, Schipper IB. Displaced distal radius fractures in children, cast alone vs additional K-wire fixation: a meta-analysis. Eur J Trauma Emerg Surg. 2019 Dec;45(6):1003-1011. doi: 10.1007/s00068-018-1011-y. Epub 2018 Oct 1.
- Background: PubMed 36913227Knopp BW, Harris M. Pediatric Forearm Fracture Characteristics as Prognostic Indicators of Healing. Cureus. 2023 Feb 7;15(2):e34741. doi: 10.7759/cureus.34741. eCollection 2023 Feb.
- Individual participant dataSharing planned: Undecided. We do not plan to submit to International Committee of Medical Journal Editors (ICMJE)
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 Restricted Activity Reccomendations and Full Activity/Limited Activity Reccomendations in people with Forearm Fractures (Both Bone Forearm Fractures, Isolated Ulnar Shaft, Isolated Radial Shaft), run by Vanderbilt University Medical Center 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 4 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: paused, as of the sponsor's last update on 30 Sep 2026. 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?
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?
Re-Displacement (time frame: From Cast Placement to Cast Removal, aproximately 6-8 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 NCT06799377, which also lists 5 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 30 Sep 2026.