Casting Versus Flexible Intramedullary Nailing in Displaced Pediatric Forearm Shaft Fractures

7-12 Year Old Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04664517
• Other study ID #: 78/1801/2020
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2021
• Source: Helsinki University Central Hospital
• Contact: Petra Grahn, MD
• Phone: +35894711
• Email: petra.grahn[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Flexible intramedullary nail (FIN)
Both bone FIN
• Reduction auder general anesthesia and long arm cast
Reduction and cast

Locations

Country	Name	City	State
Finland	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

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Need for re-interventions	Minimum value 0 no maximum value. Lower value indicates better outcome.	6 weeks, 3, 6 and 12 months
Secondary	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
Secondary	Adverse effects	adverse effects (wound infection, nerve or/and tendon damage)	6 weeks, 3, 6 and 12 months
Secondary	Cosmetic VAS	Minimum value 0 maximum value 10. Higher value indicates better satisfaction	6 weeks, 3, 6 and 12 months
Secondary	PROMIS Pediatric Item Bank v2.0 - Upper Extremity	Difference between treatment groups	6 weeks, 3, 6 months
Secondary	Upper limb ROM	Difference (percent) in elbow, wrist flexion extension and pronation-supination in comparison to uninjured side	6 weeks, 3, 6 months
Secondary	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

External Links

•   Protocol publication