Activity Levels for Forearm Fractures

(CRABB-Y Trial)

Overseen By James F Bathon, B.S.

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Metabolic bone disease, Refracture, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different activity levels affect the healing of forearm fractures in children and teenagers. It seeks to determine whether increased activity during recovery raises the risk of the fracture shifting and if it leads to other issues such as skin irritation or the need for a new cast. Participants will join one of two groups: one with restricted activity and the other with limited activity, avoiding only contact sports. Children and teenagers who have recently fractured their forearm (specifically, the radius or ulna bones) without other bone conditions or complications may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to understanding the best recovery practices for young patients.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your doctor for guidance.

What prior data suggests that these activity recommendations are safe for pediatric forearm fractures?

Research has shown that both activity plans being tested—normal activity and limited activity—are generally well-tolerated by patients with forearm fractures. For children who continue with their usual activities, studies indicate they can move around without long-term issues. Initially, they might experience weaker grip strength and less wrist movement, but these typically improve within a year, showing no major differences compared to the uninjured arm.

For those following limited activity guidelines, the findings are similar. Patients can begin simple exercises, like squeezing a towel, two weeks after the injury to aid recovery. These exercises are safe and help maintain arm movement without excessive strain.

Overall, both approaches have been used safely in many situations. However, as with any treatment, patients should inform their healthcare provider about any unusual symptoms or problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different activity levels during cast immobilization might affect recovery from forearm fractures in children. Unlike the typical approach of general activity restriction, this trial compares two distinct sets of recommendations: one emphasizes restricted activity, advising against sprinting, jumping, and organized sports, while the other allows for more freedom, permitting activities as tolerated except for contact sports. By investigating these different approaches, researchers aim to identify whether varying activity levels can influence healing outcomes, potentially leading to more personalized and effective guidance for children with forearm fractures.

What evidence suggests that this trial's activity recommendations could be effective for pediatric forearm fractures?

This trial will compare different activity recommendations for children with forearm fractures. Research has shown that limiting activity might aid in healing broken forearms in children. Some studies found that initially, children might experience weaker grip strength and reduced wrist movement compared to their uninjured arm, but these typically improve within a year. Participants in the "Restricted Activity Group" will be advised to limit activities such as sprinting, jumping, and organized sports. Meanwhile, those in the "Activity (Limited) Group" can engage in all desired activities except contact sports. Other research suggests that specific activities can help maintain or even enhance movement. For those advised to limit activity, engaging in activities they feel safe with—like non-contact sports—has not been shown to cause additional problems. While no single exercise plan suits everyone, gentle exercises like squeezing a towel can aid recovery. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for children aged 8-18 with forearm fractures, excluding those with metabolic bone diseases or a refracture. It's designed to see if being more active affects how the fracture heals and whether it moves out of place again.

Inclusion Criteria

My wrist fracture is close to the joint without affecting the growth area.

I have a broken bone in the middle of my forearm.

I have fractures in the middle of my forearm bones.

Exclusion Criteria

Initial presentation >7 days from the time of injury

I have a condition that makes my bones fragile, like Osteogenesis Imperfecta.

I have had a fracture due to weakened bones from my condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomized into activity-restricted vs activity-limited groups and monitored for fracture re-displacement and complications

6-8 weeks

Regular follow-up appointments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Full Activity/Limited Activity Recommendations
• Restricted Activity Recommendations

Trial Overview

The study compares two approaches: one group will have limited activity recommendations while the other has restricted activities (no contact sports). An ActiGraph tracker and activity surveys will monitor their movement levels to see if this influences healing or leads to complications.

How Is the Trial Designed?

Group I: Restricted Activity Group Active Control 1 Intervention

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"

Group II: Activity (Limited) Group Active Control 1 Intervention

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."

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

Closed reduction and casting for pediatric forearm fractures generally lead to satisfactory outcomes, especially in younger patients, while operative fixation is also effective but has a higher complication rate.

There is a need for high-quality randomized controlled trials to compare treatment methods (closed reduction vs. intramedullary nailing vs. plating) in children, focusing on long-term functional outcomes and complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based medicine: management of pediatric forearm fractures. Franklin, CC., Robinson, J., Noonan, K., et al.[2022]

In a study of 321 children aged 9-16, sports participation was found to increase fracture risk in boys but decrease it in girls, highlighting a significant gender difference in how physical activity impacts fracture risk.

Increased time spent watching television, computers, and videos was linked to a higher risk of wrist and forearm fractures, while engaging in light physical activity was protective against these injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Television, computer, and video viewing; physical activity; and upper limb fracture risk in children: a population-based case control study. Ma, D., Jones, G.[2022]

In a study of 112 children, those with diaphyseal forearm fractures showed significant limitations in forearm rotation, with a maximum radial bowing (MRB) of ≤6.84% correlating with ≤70° forearm pronation and ≤5.75% correlating with ≤80° supination.

The findings suggest that measuring radial bowing can help assess the impact of forearm fractures on rotation, providing a potential diagnostic tool for evaluating recovery in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of maximal radial bowing on forearm rotation in pediatric diaphyseal forearm fractures. Wongcharoenwatana, J., Eamsobhana, P., Chotigavanichaya, C., et al.[2023]

In a study of patients aged 50 and older with distal forearm fractures, men were more likely to experience high-energy fractures, while women were more likely to have low-energy fractures, highlighting gender differences in fracture causes.

The study found that individuals with distal forearm fractures have a significantly higher prevalence of osteoporosis compared to controls, and early evaluation for bone health is crucial since most subsequent fractures occur within 3 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significance of high- and low-distal energy forearm fractures. Pfister, AK., Welch, CA., Emmett, MK.[2014]

In a study of 26 children aged 3-13 with nonreduced forearm fractures, the mean dorsal angulation improved from 12° at presentation to 4° after one year, demonstrating the significant remodeling capacity of pediatric bones.

Functional outcomes, including grip strength and wrist mobility, showed initial deficits compared to the unaffected arm, but after one year, no significant differences were observed, indicating good recovery in function over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evolution of hand function during remodelling in nonreduced angulated paediatric forearm fractures: a prospective cohort study. Barvelink, B., Ploegmakers, JJW., Harsevoort, AGJ., et al.[2022]

In a study of 33 children with distal radius fractures that healed with an angulation of 15° or more, all fractures showed significant remodeling over an average follow-up of 9 months, reducing mean angulation from 23° to 8° in the dorsovolar plane.

The speed of remodeling was found to be faster for fractures with greater initial angulation, averaging 2.5° per month, but this speed decreased exponentially over time, indicating that more severely angulated fractures may initially remodel more quickly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Malunion of distal radius fractures in children. Jeroense, KT., America, T., Witbreuk, MM., et al.[2018]

In a study of 2506 distal forearm fractures in Zaragoza, Spain, the majority (78.2%) were caused by low-energy injuries, with a notable increase in fractures among individuals over 50 years old, particularly due to falls.

The study revealed a gender difference in fracture incidence: males under 49 were more likely to suffer fractures from traffic accidents, while females over 50 were more affected due to osteoporosis-related falls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The incidence of distal forearm fractures in Zaragoza (Spain). Cuenca, J., Martínez, AA., Herrera, A., et al.[2022]

In a study of 53 children under 15 years with conservatively treated forearm fractures, all fractures healed within 8 weeks, but over half (52.8%) experienced limitations in rotational movements after an average follow-up of 3 years.

Factors contributing to these limitations included angulatory deformities greater than 10 degrees, particularly in older children, and rotational malalignment, which did not improve with growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study of radioulnar movements following fractures of the forearm in children. Daruwalla, JS.[2005]

In a clinical trial involving 50 children with unstable forearm fractures, single-bone fixation was found to be safe and resulted in a significantly shorter surgical time compared to both-bone fixation (43.6 minutes vs. 88.6 minutes).

Both fixation methods achieved excellent functional outcomes and fracture union rates, with no complications or refractures, although single-bone fixation had a higher risk of radius re-angulation, which remained clinically acceptable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-bone versus both-bone plating of unstable paediatric both-bone forearm fractures. A randomized controlled clinical trial. Khaled, M., Fadle, AA., Attia, AK., et al.[2022]

A systematic review of 409 children aged 5 to 17 with both-bone forearm fractures found that both intramedullary nailing (IMN) and plating are effective treatment options, showing similar functional and radiological outcomes.

IMN was associated with shorter operative and anesthetic times and better cosmetic results, although it also resulted in longer fluoroscopic exposure, indicating it may be a preferable option in certain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and Radiological Outcomes of Paediatric Forearm Fractures of the Radius and Ulna Following Fixation by Intramedullary Nailing or Plating: A Systematic Review. Mmerem, K., Beeharry, MW.[2023]

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Activity Levels for Forearm Fractures (CRABB-Y Trial)

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Sports and Recreation-Related Wrist Fractures

The top 10 sports for wrist fractures that had statistically significant increases during the study period were all-terrain vehicles (ATVs) (p < ...