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Behavioural Intervention

Activity Levels for Forearm Fractures (CRABB-Y Trial)

Nashville, TN

N/A

Recruiting

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must not have

Any patient with known bone fragility condition (e.g. Osteogenesis imperfecta)

Pathologic fracture

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from casting to cast removal, approximately 6-8 weeks.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the effect of activity on the re-displacement of forearm fractures in children aged 8-18 years old. They want to know if increased activity leads to more re-displacement

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Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

There are no medicinal side effects as this trial involves activity recommendations rather than drugs. However, potential risks include skin irritation, need for re-casting, or surgery due to increased activity possibly affecting fracture displacement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a broken wrist near the end of the bone.

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

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

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I have fractures in the middle of my forearm bones.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have a bone condition like osteoporosis.

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I needed surgery as my first treatment.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from casting to cast removal, approximately 6-8 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from casting to cast removal, approximately 6-8 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from casting to cast removal, approximately 6-8 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Re-Displacement

Secondary study objectives

Activity Level as measured by patient-completed validated activity surveys (PAQ)

Activity Level as measured by patient-worn activity trackers

Complications

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Restricted Activity GroupActive Control1 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) GroupActive Control1 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."

0 / 8Eligibility criteria met