Understanding how activity affects healing in children's forearm fractures
Complications Related to Activity After Both Bone Fractures: Why do we Restrict Activity?
This study is testing how different levels of activity affect the healing of forearm fractures in children aged 8-18 to see if being more active leads to more problems with healing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06799377 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to investigate the impact of activity levels on the re-displacement of pediatric forearm fractures in children aged 8-18 years. Participants will be randomly assigned to either an activity-restricted group or an activity-limited group, with some using an ActiGraph Activity tracker to monitor their activity. The study will assess whether increased activity correlates with higher rates of re-displacement and other complications during treatment. Additionally, it will evaluate how activity restrictions influence overall patient activity levels.
Who should consider this trial
Good fit: Ideal candidates are children aged 8-18 with specific types of forearm fractures who do not have metabolic bone diseases.
Not a fit: Patients with known metabolic bone diseases or those requiring surgical intervention for their fractures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved guidelines for activity levels during the healing process of pediatric forearm fractures.
How similar studies have performed: While similar studies have explored activity levels in fracture healing, this specific approach focusing on pediatric forearm fractures is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Where this trial is running
Nashville, Tennessee
- Vanderbilt Children's Hospital Orthopedics Clinic — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Nathaniel Lempert, M.D.
- Email: nathaniel.lempert@vumc.org
- Phone: 419-344-3993
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.