Displaced distal radius fractures in children, cast alone vs additional K-wire fixation: a meta-analysis.
Alysia Sengab, Pieta Krijnen, Inger Birgitta Schipper
https://pubmed.ncbi.nlm.nih.gov/30276723/Actively Recruiting
Led by Vanderbilt University Medical Center · Updated on 2025-07-10
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
Researchers are studying how activity levels affect the risk of re-displacement and complications in children aged 8 to 18 years with forearm fractures. The study aims to find out whether increased activity during cast treatment leads to more re-displacements or other issues like skin irritation, re-casting, or surgery. It also examines if activity restrictions influence how active children really are during recovery. Participants are randomly assigned to one of two groups a restricted activity group advised to avoid strenuous play and sports, focusing on feet on the floor activities or a limited activity group allowed to engage in most activities except contact sports, with guidance to avoid pain or safety risks. Some children will wear activity trackers, and all will complete activity surveys at follow-up visits. The study period covers from casting to cast removal, about 6 to 8 weeks. Throughout the study, children will have regular follow-up appointments where researchers will collect data on activity levels via surveys and trackers, and monitor for complications or re-displacement of the fracture. The main measure is whether the fracture moves again during treatment. Secondary measures include activity levels and any complications. The total participation duration is approximately 6 to 8 weeks from initial presentation to cast removal.
CONDITIONS
Complications Related To Activity After Pediatric Both Bone Fractures: Exploring the Effects of Activity on Fracture Displacement
N
Nathaniel Lempert, M.D.
J
James F Bathon, B.S.
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Vanderbilt University Medical Center
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Activity Restriction During Casting | Activity as Tolerated During Casting |
|---|---|---|
| What it is | Participants follow explicit "restricted activity" recommendations, avoiding sprinting, jumping, organized sports, playgrounds, and gym class, with an emphasis on "feet on the floor" play during casting. | Participants are advised to participate in all typical activities as comfortable (except contact sports), including sprinting, jumping, and playground use, unless they experience pain, throughout the casting period. |
| Role in this trial | Tests whether restricting activity during immobilization lowers the risk of fracture displacement or other complications in children with both-bone forearm fractures. | Serves as the control group where activity is permitted as comfort allows, testing whether unrestricted movement increases risk of re-displacement or other issues. |
| Main purpose or use | To examine if activity limitation prevents re-displacement and additional complications during the healing period with a cast. | To assess if activity as tolerated leads to higher rates of complications or supports safe participation without strict limitations during casting. |
| How it is performed | Families are instructed to limit the child’s strenuous activity, avoid gyms and playgrounds, and follow guidance emphasizing non-strenuous play while wearing a cast. | Families are advised to allow the child to participate in all desired activities except contact sports, ceasing activity only if the child experiences pain or safety concerns. |
| Evidence status | Ongoing clinical trial; results regarding complication rates with strict activity limitation during casting are not yet established in this population. | Ongoing clinical trial; rates of fracture re-displacement and other complications with activity as tolerated during casting in this group remain under study. |
| Important limitations | Strict adherence to activity restriction may be challenging for some families. The optimal degree of limitation and its influence on healing or real-world outcomes is still being determined. | It remains uncertain whether allowing increased physical activity while in a cast increases complication rates or impacts healing, and the study is ongoing. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Approximately 6 to 8 weeks (duration of cast immobilization)
Participants follow activity recommendations during the casting period to study the effects of activity on fracture displacement and complications.
Regular clinic visits during casting period for monitoring
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Alysia Sengab, Pieta Krijnen, Inger Birgitta Schipper
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https://pubmed.ncbi.nlm.nih.gov/26057068/Vanderbilt University Medical Center
Lead Sponsor