Casting Versus Flexible Intramedullary Nailing in Displaced Pediatric Forearm Shaft Fractures
- Conditions
- 7-12 Year OldBoth Bone Forearm FractureAO Classification 22D/2.1-5.2
- Interventions
- Procedure: Flexible intramedullary nail (FIN)Procedure: Reduction auder general anesthesia and long arm cast
- Registration Number
- NCT04664517
- Lead Sponsor
- Helsinki University Central Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FIN (Flexible intramedullary nail) Flexible intramedullary nail (FIN) Fracture reduction and fixation using flexible intramedullary nails. Nails size is 0.4 times the smallest diameter of the medullary canal of radius or ulna measured in radiographs. Long arm cast Reduction auder general anesthesia and long arm cast Fractures are reduced under general anesthesia within 3 days from injury and a synthetic circular above elbow cast in neutral pro-supination is applied for six weeks. Patient Choice FIN Flexible intramedullary nail (FIN) Fracture reduction and fixation using flexible intramedullary nails. Nails size is 0.4 times the smallest diameter of the medullary canal of radius or ulna measured in radiographs. Patient Choice cast Reduction auder general anesthesia and long arm cast Fractures are reduced under general anesthesia within 3 days from injury and a synthetic circular above elbow cast in neutral pro-supination is applied for six weeks.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Cosmetic VAS 6 weeks, 3, 6 and 12 months Minimum value 0 maximum value 10. Higher value indicates better satisfaction
PROMIS Pediatric Item Bank v2.0 - Upper Extremity 6 weeks, 3, 6 months Difference between treatment groups
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.
Need for re-interventions 6 weeks, 3, 6 and 12 months Minimum value 0 no maximum value. Lower value indicates better outcome.
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.
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
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.
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)
Trial Locations
- Locations (5)
Kuopio University Hospital
🇫🇮Kuopio, Finland
HUS New Childrens Hospital
🇫🇮Helsinki, Finland
Oulu University Hospital
🇫🇮Oulu, Finland
Tampere University Hospital
🇫🇮Tampere, Finland
Turku University Hospital
🇫🇮Turku, Finland