Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04664517
Status:
RECRUITING
Last Update Posted:
2021-07-30
First Post:
2020-12-06
Brief Title:
Casting Versus Flexible Intramedullary Nailing in Displaced Pediatric Forearm Shaft Fractures
Sponsor:
Helsinki University Central Hospital
Organization:
Helsinki University Central Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 10mm of shortening in displaced both bone forearm shaft fractures AO-pediatric classification 22D21-52 A total of 78 patients with minimum 2 years of expected growth left are randomized in 11 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 v20 - 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
Primary outcome is 1 PROMIS Pediatric Item Bank v20 - 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None