7-12 Year Old, AO Classification 22D/2.1-5.2, Both Bone Forearm Fracture
Conditions
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.
Interventions
PROCEDUREFlexible intramedullary nail (FIN)
Both bone FIN
PROCEDUREReduction auder general anesthesia and long arm cast
Reduction and cast
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
multicenter, randomized superiority trial. Parallell patient choice arm.
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Pediatric Item Bank v2.0 - Upper Extremity | 12 months | We aim to confirm that 75 percent of FIN patients have a better PROMIS UE score than what the mean score of the cast patients will be assuming both groups have the same standard deviation. PROMIS (Patient-Reported Outcomes Measurement Information System) scores are normalized to a mean score of 50, standard deviation of 10, with a theoretical range of 0 to 100. A higher score corresponds to a greater amount of the domain being measured. |
| Pro-supination | 12 months | Difference (percent) in forearm pronation-supination range of motion (ROM) at one-year follow-up in comparison to uninjured side. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement Model for the Pediatric Quality of Life Inventory Pediatric Pain Questionaire (PEDS QL PPQ) | 6 weeks, 3, 6 and 12 months | Minimum value 0 maximum value 10. Higher value indicates higher pain intensity |
| Need for re-interventions | 6 weeks, 3, 6 and 12 months | Minimum value 0 no maximum value. Lower value indicates better outcome. |
| Rate of participants with malunion | 6 weeks, 3, 6 and 12 months | malunion, delayed union (defined as nonunion at 3 months or later), pseudoarthrosis (defined as 3 cortices out of 4 not united at 6 months or later) |
| Adverse effects | 6 weeks, 3, 6 and 12 months | adverse effects (wound infection, nerve or/and tendon damage) |
| Quick Disabilities of the Arm, Shoulder and Hand score | 6 weeks, 3, 6 and 12 months | Minimum value is 0 and maximum 100. Higher value indicates worse function. Statistically significant difference in QuickDASH score is 6.8 (18) at 12 months FU. |
| PROMIS Pediatric Item Bank v2.0 - Upper Extremity | 6 weeks, 3, 6 months | Difference between treatment groups |
| Upper limb ROM | 6 weeks, 3, 6 months | Difference (percent) in elbow, wrist flexion extension and pronation-supination in comparison to uninjured side |
| Return to sport/musical instrument and level | 6 weeks, 3, 6 and 12 months | Level of practiced sport or musical instrument before and at end of trial, as well as time from injury to return to hobby is registered. |
| Cosmetic VAS | 6 weeks, 3, 6 and 12 months | Minimum value 0 maximum value 10. Higher value indicates better satisfaction |
| Measurement Model for the Pediatric Quality of Life Inventory (PedsQL) | 6 weeks, 3, 6 and 12 months | Minimum value is 0 and maximum value is 100. Higher score indicates better health related quality of life. |
Countries
Finland
Contacts
Primary ContactPetra Grahn, MD
Outcome results
None listed