Casting versus flexible intramedullary nailing in displaced forearm shaft fractures in children aged 7-12 years: a study protocol for a randomised controlled trial

Petra M Grahn-Shahar, Juha-Jaakko Sinikumpu, Yrjänä Nietosvaara, Johanna Syvänen, Anne Salonen, Matti Ahonen, Ilkka Helenius

Research output: Contribution to journalArticleScientificpeer-review

Abstract

Introduction 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 immobilisation. Diaphyseal fractures in children have poor remodelling capacity. Malunion can cause permanent cosmetic and functional disability. Internal fixation with flexible intramedullary nails has gained increasing popularity, without evidence of a better outcome compared with closed reduction and cast immobilisation.

Method and analysis This is a multicentre, randomised superiority trial comparing closed reduction and cast immobilisation to flexible intramedullary nails in children aged 7-12 years with >10 degrees of angulation and/or >10 mm of shortening in displaced both bone forearm shaft fractures (AO-paediatric classification: 22D/2.1-5.2). A total of 78 patients with minimum 2 years of expected growth left are randomised in 1:1 ratio to either treatment group. The study has a parallel non-randomised patient preference arm. Both treatments are performed under general anaesthesia. In the cast group a long arm cast is applied for 6 weeks. The flexible intramedullary nail group is immobilised in a collar and cuff sling for 4 weeks. Data are collected at baseline and at each follow-up until 1 year.

Primary outcome is (1) PROMIS paediatric upper extremity and (2) forearm pronation-supination range of motion at 1-year follow-up. Secondary outcomes are Quick DASH, Paediatric Pain Questionnaire, Cosmetic Visual Analogue Scale, wrist and elbow range of motion as well as any complications and costs of treatment. We hypothesise that flexible intramedullary nailing results in a superior outcome.

Ethics and dissemination We have received ethical board approval (number: 78/1801/2020) and permissions to conduct the study from all five participating university hospitals. Informed consent is obtained from the parent(s). Results will be disseminated in peer-reviewed publications.

Original languageEnglish
Article number048248
JournalBMJ Open
Volume11
Issue number8
Number of pages7
ISSN2044-6055
DOIs
Publication statusPublished - 2021
MoE publication typeA1 Journal article-refereed

Fields of Science

  • 3126 Surgery, anesthesiology, intensive care, radiology
  • paediatric orthopaedics
  • hand & wrist
  • paediatric surgery
  • paediatric orthopaedic & trauma surgery
  • QUALITY-OF-LIFE
  • MALUNITED FRACTURES
  • OPERATIVE TREATMENT
  • OPEN REDUCTION
  • OUTCOMES
  • COMPLICATIONS
  • MANAGEMENT
  • RADIUS
  • BONES
  • ULNA

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