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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FIN (Flexible intramedullary nail) | Active Comparator | 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. |
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| Long arm cast | Active Comparator | 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. |
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| Patient Choice FIN | Other | 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. |
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| Patient Choice cast | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flexible intramedullary nail (FIN) | Procedure | Both bone FIN |
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| Measure | Description | Time Frame |
|---|---|---|
| PROMIS 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. | 12 months |
| Pro-supination | Difference (percent) in forearm pronation-supination range of motion (ROM) at one-year follow-up in comparison to uninjured side. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks, 3, 6 and 12 months |
| Measurement Model for the Pediatric Quality of Life Inventory (PedsQL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Petra Grahn, MD | Contact | +35894711 | petra.grahn@hus.fi |
| Name | Affiliation | Role |
|---|---|---|
| Ilkka Helenius, MD | Helsinki University Central Hospital | Study Director |
| Petra Grahn, MD | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HUS New Childrens Hospital | Recruiting | Helsinki | 00029HUS | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34417215 | Derived | 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. |
| Label | URL |
|---|---|
| Protocol publication | View source |
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All data will be available upon request. Data will be delivered as anonymized.
Study protocol is published in BMJ open. What can not be found there can be shared by contacting the main investigator.
Please see the study protocol in BMJ open
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multicenter, randomized superiority trial. Parallell patient choice arm.
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| Reduction auder general anesthesia and long arm cast | Procedure | Reduction and cast |
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Minimum value is 0 and maximum value is 100. Higher score indicates better health related quality of life. |
| 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 | 6 weeks, 3, 6 and 12 months |
| Need for re-interventions | Minimum value 0 no maximum value. Lower value indicates better outcome. | 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) | 6 weeks, 3, 6 and 12 months |
| Adverse effects | adverse effects (wound infection, nerve or/and tendon damage) | 6 weeks, 3, 6 and 12 months |
| Cosmetic VAS | Minimum value 0 maximum value 10. Higher value indicates better satisfaction | 6 weeks, 3, 6 and 12 months |
| PROMIS Pediatric Item Bank v2.0 - Upper Extremity | Difference between treatment groups | 6 weeks, 3, 6 months |
| Upper limb ROM | Difference (percent) in elbow, wrist flexion extension and pronation-supination in comparison to uninjured side | 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. | 6 weeks, 3, 6 and 12 months |
| Kuopio University Hospital | Recruiting | Kuopio | Finland |
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| Oulu University Hospital | Not yet recruiting | Oulu | Finland |
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| Tampere University Hospital | Not yet recruiting | Tampere | Finland |
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| Turku University Hospital | Recruiting | Turku | Finland |
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