Casting Versus Flexible Intramedullary Nailing in Displaced Pediatric Forearm Shaft Fractures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Flexible intramedullary nail (FIN), Reduction auder general anesthesia and long arm cast.
- Who it may be relevant to
- Registry conditions: Both Bone Forearm Fracture, AO Classification 22D/2.1-5.2, 7-12 Year Old. Basic parameters: 7 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Casting Versus Flexible Intramedullary Nailing in Displaced Forearm Shaft Fractures in 7 to 12 Years Old Children: A Study Protocol for a Randomized Controlled Trial
Overview
The forearm is the most common fracture location in children, with an increasing incidence. Displaced forearm shaft fractures have traditionally been treated with closed reduction and cast immobilization. Diaphyseal fractures in children have poor remodeling capacity, and malunion can thus cause permanent cosmetic and functional disability. Internal fixation especially with flexible intramedullary nails has gained increasing popularity, without evidence of a better outcome compared to closed reduction and cast immobilization.
Detailed description
This is a multicenter, randomized superiority trial comparing closed reduction and cast immobilization to flexible intramedullary nails in 7-12 year old children with \> 10° of angulation and/or \> 10mm of shortening in displaced both bone forearm shaft fractures (AO-pediatric classification: 22D/2.1-5.2). A total of 78 patients with minimum 2 years of expected growth left are randomized in 1:1 ratio to either treatment group. The study has a parallel non-randomized patient preference arm. Both treatments are performed under general anesthesia. In the cast group a long arm cast is applied for 6 weeks. The flexible intramedullary nail group is immobilized in a collar and cuff sling for 4 weeks. Data is collected at baseline and at each follow-up until 1 year.
Primary outcome is 1) PROMIS Pediatric Item Bank v2.0 - Upper Extremity and 2) forearm pronation-supination range of motion at one-year follow-up. Secondary outcomes are Quick DASH, Pediatric pain questionnaire, Cosmetic VAS, wrist range of motion as well as any complications (malunion, delayed union, non-union or deep wound infection, peripheral nerve injury, need for re-intervention during 1-year follow-up) and costs of treatment.
The investigators hypothesize that flexible intramedullary nailing results in a superior outcome.
Interventions
- Procedure Flexible intramedullary nail (FIN)
Both bone FIN - Procedure Reduction auder general anesthesia and long arm cast
Reduction and cast
Primary outcome measures
- PROMIS Pediatric Item Bank v2.0 - Upper Extremity [Time frame: 12 months]
- Pro-supination [Time frame: 12 months]
Secondary outcome measures (10)
- Quick Disabilities of the Arm, Shoulder and Hand score [Time frame: 6 weeks, 3, 6 and 12 months]
- Measurement Model for the Pediatric Quality of Life Inventory (PedsQL) [Time frame: 6 weeks, 3, 6 and 12 months]
- Measurement Model for the Pediatric Quality of Life Inventory Pediatric Pain Questionaire (PEDS QL PPQ) [Time frame: 6 weeks, 3, 6 and 12 months]
- Need for re-interventions [Time frame: 6 weeks, 3, 6 and 12 months]
- Rate of participants with malunion [Time frame: 6 weeks, 3, 6 and 12 months]
- Adverse effects [Time frame: 6 weeks, 3, 6 and 12 months]
- Cosmetic VAS [Time frame: 6 weeks, 3, 6 and 12 months]
- PROMIS Pediatric Item Bank v2.0 - Upper Extremity [Time frame: 6 weeks, 3, 6 months]
- Upper limb ROM [Time frame: 6 weeks, 3, 6 months]
- Return to sport/musical instrument and level [Time frame: 6 weeks, 3, 6 and 12 months]
Eligibility criteria
Inclusion criteria
- 7 to12 year old children
- Open distal radial physis
- Both bone forearm shaft fractures (AO-pediatric classification: 22D/2.1-5.2)
- More than 10 degrees of angulation
- with or without less than 10mm of shortening
Exclusion criteria
- Patients with bilateral fractures
- Gustilo-Anderson grade I-III open fracture
- Neurovascular deficit
- Compartment syndrome
- Pathologic fracture
- Patient not able to give a written informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Finland · 5 centers
- HUS New Childrens Hospital — Helsinki
- Kuopio University Hospital — Kuopio
- Oulu University Hospital — Oulu
- Tampere University Hospital — Tampere
- Turku University Hospital — Turku
Publications
- Grahn P, Sinikumpu JJ, Nietosvaara Y, Syvanen J, Salonen A, Ahonen M, Helenius I. Casting versus flexible intramedullary nailing in displaced forearm shaft fractures in children aged 7-12 years: a study protocol for a randomised controlled trial. BMJ Open. 2021 Aug 20;11(8):e048248. doi: 10.1136/bmjopen-2020-048248. PMID 34417215
Identifiers
NCT: NCT04664517 · 78/1801/2020