Clinical trial NCT04664517: Casting Versus Flexible Intramedullary Nailing in Displaced Pediatric Forearm Shaft Fractures
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Both Bone Forearm Fracture
AO Classification 22D/2.1-5.2
7-12 Year Old
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 90
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicenter, randomized superiority trial. Parallell patient choice arm.
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: PROMIS Pediatric Item Bank v2.0 - Upper Extremity
timeFrame: 12 months
measure: Pro-supination
timeFrame: 12 months
Secondary outcomes:
measure: Quick Disabilities of the Arm, Shoulder and Hand score
timeFrame: 6 weeks, 3, 6 and 12 months
measure: Measurement Model for the Pediatric Quality of Life Inventory (PedsQL)
timeFrame: 6 weeks, 3, 6 and 12 months
measure: Measurement Model for the Pediatric Quality of Life Inventory Pediatric Pain Questionaire (PEDS QL PPQ)
timeFrame: 6 weeks, 3, 6 and 12 months
measure: Need for re-interventions
timeFrame: 6 weeks, 3, 6 and 12 months
measure: Rate of participants with malunion
timeFrame: 6 weeks, 3, 6 and 12 months
measure: Adverse effects
timeFrame: 6 weeks, 3, 6 and 12 months
measure: Cosmetic VAS
timeFrame: 6 weeks, 3, 6 and 12 months
measure: PROMIS Pediatric Item Bank v2.0 - Upper Extremity
timeFrame: 6 weeks, 3, 6 months
measure: Upper limb ROM
timeFrame: 6 weeks, 3, 6 months
measure: Return to sport/musical instrument and level
timeFrame: 6 weeks, 3, 6 and 12 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: HUS New Childrens Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Ilkka Helenius, MD
role: STUDY_DIRECTOR
affiliation: Helsinki University Central Hospital
name: Petra Grahn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.