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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
Both bone FIN
Reduction and cast
HUS New Childrens Hospital
Helsinki, Finland
RECRUITINGKuopio University Hospital
Kuopio, Finland
RECRUITINGOulu University Hospital
Oulu, Finland
NOT_YET_RECRUITINGTampere University Hospital
Tampere, Finland
NOT_YET_RECRUITINGTurku University Hospital
Turku, Finland
RECRUITINGPROMIS Pediatric Item Bank v2.0 - Upper Extremity
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.
Time frame: 12 months
Pro-supination
Difference (percent) in forearm pronation-supination range of motion (ROM) at one-year follow-up in comparison to uninjured side.
Time frame: 12 months
Quick Disabilities of the Arm, Shoulder and Hand score
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.
Time frame: 6 weeks, 3, 6 and 12 months
Measurement Model for the Pediatric Quality of Life Inventory (PedsQL)
Minimum value is 0 and maximum value is 100. Higher score indicates better health related quality of life.
Time frame: 6 weeks, 3, 6 and 12 months
Measurement Model for the Pediatric Quality of Life Inventory Pediatric Pain Questionaire (PEDS QL PPQ)
Minimum value 0 maximum value 10. Higher value indicates higher pain intensity
Time frame: 6 weeks, 3, 6 and 12 months
Need for re-interventions
Minimum value 0 no maximum value. Lower value indicates better outcome.
Time frame: 6 weeks, 3, 6 and 12 months
Rate of participants with malunion
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)
Time frame: 6 weeks, 3, 6 and 12 months
Adverse effects
adverse effects (wound infection, nerve or/and tendon damage)
Time frame: 6 weeks, 3, 6 and 12 months
Cosmetic VAS
Minimum value 0 maximum value 10. Higher value indicates better satisfaction
Time frame: 6 weeks, 3, 6 and 12 months
PROMIS Pediatric Item Bank v2.0 - Upper Extremity
Difference between treatment groups
Time frame: 6 weeks, 3, 6 months
Upper limb ROM
Difference (percent) in elbow, wrist flexion extension and pronation-supination in comparison to uninjured side
Time frame: 6 weeks, 3, 6 months
Return to sport/musical instrument and level
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.
Time frame: 6 weeks, 3, 6 and 12 months
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