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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Full Activity/Limited Activity Recommendations, Restricted Activity Recommendations for forearm fractures?

The research suggests that forearm fractures in children often heal well with conservative treatment, like casting, due to the excellent remodeling ability of young bones. Studies show that even with some initial limitations in movement, children typically regain full function over time, indicating that activity recommendations can be effective in managing recovery. ^{1 2 3 4 5}

How does the treatment for activity levels in forearm fractures differ from other treatments?

This treatment is unique because it focuses on recommending different levels of physical activity (full, limited, or restricted) after a forearm fracture, rather than traditional methods like casting or surgery. It aims to manage recovery by adjusting activity levels, which is not a standard approach for forearm fractures. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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 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 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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evidence-based medicine: management of pediatric forearm fractures. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

The evolution of hand function during remodelling in nonreduced angulated paediatric forearm fractures: a prospective cohort study. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Single-bone versus both-bone plating of unstable paediatric both-bone forearm fractures. A randomized controlled clinical trial. [2022]

5. Sweden pubmed.ncbi.nlm.nih.gov

Malunion of distal radius fractures in children. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Significance of high- and low-distal energy forearm fractures. [2014]

7. France pubmed.ncbi.nlm.nih.gov

The incidence of distal forearm fractures in Zaragoza (Spain). [2022]

8. United States 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. [2022]

9. Italy pubmed.ncbi.nlm.nih.gov

The effects of maximal radial bowing on forearm rotation in pediatric diaphyseal forearm fractures. [2023]

10. United States 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. [2023]