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NCT Number: NCT04664517

Casting Versus Flexible Intramedullary Nailing in Displaced Pediatric Forearm Shaft Fractures

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.

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Key information

Conditions

Both Bone Forearm Fracture 7-12 Year Old AO Classification 22D/2.1-5.2

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HUS New Childrens Hospital, Helsinki, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flexible intramedullary nail (FIN)

Procedure

Both bone FIN

Reduction auder general anesthesia and long arm cast

Procedure

Reduction and cast

Primary outcomes

  1. PROMIS Pediatric Item Bank v2.0 - Upper Extremity

    Time frame: 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.

  2. Pro-supination

    Time frame: 12 months

    Difference (percent) in forearm pronation-supination range of motion (ROM) at one-year follow-up in comparison to uninjured side.

Secondary outcomes

  1. Quick Disabilities of the Arm, Shoulder and Hand score

    Time frame: 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.

  2. Measurement Model for the Pediatric Quality of Life Inventory (PedsQL)

    Time frame: 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.

  3. Measurement Model for the Pediatric Quality of Life Inventory Pediatric Pain Questionaire (PEDS QL PPQ)

    Time frame: 6 weeks, 3, 6 and 12 months

    Minimum value 0 maximum value 10. Higher value indicates higher pain intensity

  4. Need for re-interventions

    Time frame: 6 weeks, 3, 6 and 12 months

    Minimum value 0 no maximum value. Lower value indicates better outcome.

  5. Rate of participants with malunion

    Time frame: 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)

  6. Adverse effects

    Time frame: 6 weeks, 3, 6 and 12 months

    adverse effects (wound infection, nerve or/and tendon damage)

  7. Cosmetic VAS

    Time frame: 6 weeks, 3, 6 and 12 months

    Minimum value 0 maximum value 10. Higher value indicates better satisfaction

  8. PROMIS Pediatric Item Bank v2.0 - Upper Extremity

    Time frame: 6 weeks, 3, 6 months

    Difference between treatment groups

  9. Upper limb ROM

    Time frame: 6 weeks, 3, 6 months

    Difference (percent) in elbow, wrist flexion extension and pronation-supination in comparison to uninjured side

  10. Return to sport/musical instrument and level

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Petra Grahn, MD

CONTACT

[email protected]

+35894711

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

Casting Versus Flexible Intramedullary Nailing in Displaced Forearm Shaft Fractures in 7 to 12 Years Old Children: A Study Protocol for a Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 11, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.