Casting Versus Flexible Intramedullary Nailing in Displaced Pediatric Forearm Shaft Fractures

Not Applicable

Recruiting

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

• 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.

Study Timeline

• Study First Submitted: 2020-12-06
• Study First Submitted QC: 2020-12-10
• Study First Posted: 2020-12-11
• Study Start: 2021-05-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-23
• Last Update Posted: 2021-07-30
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

HUS New Childrens Hospital; 🇫🇮 Helsinki, Finland

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland

Turku University Hospital; 🇫🇮 Turku, Finland