Casting Versus Flexible Intramedullary Nailing in Displaced Pediatric Forearm Shaft Fractures

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

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.

Study Overview

• Status: Recruiting
• Conditions: Both Bone Forearm Fracture; AO Classification 22D/2.1-5.2; 7-12 Year Old
• Intervention / Treatment: Procedure: Flexible intramedullary nail (FIN); Procedure: Reduction auder general anesthesia and long arm cast

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Petra Grahn, MD; Phone Number: +35894711; Email: petra.grahn@hus.fi

Study Locations

• Finland
  • Helsinki, Finland, 00029HUS
    • Recruiting
    • HUS New Childrens Hospital
    • Contact: Petra Grahn, MD; Phone Number: +358 9 4711
    • Contact: Matti Ahonen, MD; Phone Number: + 358 9 4711
  • Kuopio, Finland
    • Recruiting
    • Kuopio University Hospital
    • Contact: Yrjänä Nietosvaara, MD
  • Oulu, Finland
    • Not yet recruiting
    • Oulu University Hospital
    • Contact: Juha-Jaakko Sinikumpu, MD
  • Tampere, Finland
    • Not yet recruiting
    • Tampere University Hospital
    • Contact: Anne Salonen, MD
  • Turku, Finland
    • Recruiting
    • Turku University Hospital
    • Contact: Johanna Syvänen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FIN (Flexible intramedullary nail); 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.	Procedure: Flexible intramedullary nail (FIN); Both bone FIN
Active Comparator: 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.	Procedure: Reduction auder general anesthesia and long arm cast; Reduction and cast
Other: Patient Choice 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.	Procedure: Flexible intramedullary nail (FIN); Both bone FIN
Other: Patient Choice 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.	Procedure: Reduction auder general anesthesia and long arm cast; Reduction and cast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Study Director: Ilkka Helenius, MD, Helsinki University Central Hospital; Principal Investigator: Petra Grahn, MD, Helsinki University Central Hospital

Publications and helpful links

General Publications

• Grahn P, Sinikumpu JJ, Nietosvaara Y, Syvänen 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.

Helpful Links

• Protocol publication

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: December 6, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): July 30, 2021
• Last Update Submitted That Met QC Criteria: July 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 78/1801/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All data will be available upon request. Data will be delivered as anonymized.
• IPD Sharing Time Frame: Study protocol is published in BMJ open. What can not be found there can be shared by contacting the main investigator.
• IPD Sharing Access Criteria: Please see the study protocol in BMJ open
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No