Status:
UNKNOWN
Comparative Trial of Operative Treatment of Distal Pediatric Forearm Fractures With Biodegradable Nails and K-wires
Lead Sponsor:
Péterfy Sándor Hospital
Conditions:
Fracture Wrist
Eligibility:
All Genders
3-13 years
Phase:
NA
Brief Summary
The study is designed as a multicenter trial for the treatment of distal pediatric forearm fractures (=severely displaced distal metaphyseal forearm fractures) with a PLGA-based biodegradable intramed...
Detailed Description
Over the last decade, there has been an increasing demand to overcome the disadvantages associated with conventional implant materials, by developing new, alternative materials and material production...
Eligibility Criteria
Inclusion
- Clinical diagnosis of distal radial or complete forearm fracture Metaphyseal radial/or distal forearm fractures with complete displacement and shortening.
- Age between of 3-13 years. Open physeal plates on X-rays. Closed or Grade I. open fractures Ability and willingness to give an informed consent
Exclusion
- Pathological fractures (e.g. bone cyst) Poly-traumatized patient Inability or unwillingness to give informed consent Closed physeal plates on X-rays. Active skin infection in the surgical area
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT04848818
Start Date
March 1 2020
End Date
October 1 2022
Last Update
April 19 2021
Active Locations (4)
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1
Szent János Hospital
Budapest, Diós Árok 1., Hungary, 1125
2
Péterfy Hospital
Budapest, Fiumei Út 17, Hungary, 1081
3
Medical University of Pécs, Pediatric Surgery
Pécs, József Attila U 7., Hungary, 7623
4
Heim Pál Hospital
Budapest, Üllöi Út 86, Hungary, 1089