Status:
COMPLETED
Treatment of Children's Forearm Shaft Fractures With Biodegradable Intramedullary Nailing, Compared With Elastic Stable Intramedullary Nailing
Lead Sponsor:
Oulu University Hospital
Collaborating Sponsors:
Kanta-Häme Central Hospital
Bioretec Ltd.
Conditions:
Fractures, Bone
Injury Arm
Eligibility:
All Genders
4-16 years
Phase:
NA
Brief Summary
The study purpose is to investigate long-term biodegradation process of the polylactide-co-glycolide (PLGA) intramedullary nails, used in treating the forearm shaft fractures in children. The primary ...
Detailed Description
This is a prospective observational clinical study in two centers in Finland. The study cannot be executed in a blinded fashion, because all patients treated by the study method will be invited. The ...
Eligibility Criteria
Inclusion
- • Patients who have participated in the previous study, concerning the surgical treatment of forearm shaft fracture and have been treated by biodegradable intramedullary nailing (BIN), using the polylactide-co-glycolide nails (ActivaNail).
Exclusion
- • The cases that have primarily been enrolled but interrupted the first study because of new fracture and been therefore surgically fixed with traditional (metallic) implants will be excluded.
Key Trial Info
Start Date :
January 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04385745
Start Date
January 5 2019
End Date
January 1 2023
Last Update
June 15 2023
Active Locations (1)
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1
Oulu University Hospital and University of Oulu
Oulu, Finland, 90140