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Comparative Trial of Operative Treatment of Distal Pediatric Forearm Fractures With Biodegradable Nails and K-wires

NCT04848818 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2021-04-19

No results posted yet for this study

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 intramedullary implant in children. The primary objective of the trial is to evaluate clinical outcome between Activa IM-Nail™ and K-wire in this indication. The secondary objective is to evaluate potential differences of potential complications in the operative method with either a biodegradable intramedullary PLGA-implant or with conventional K-wires. K-wire osteosynthesis will be made according to the conventional surgical technique by three paediatric trauma centers. Intramedullary PLGA implantation will be made by the Péterfy Hospital. The surgical indication will be the same in all groups, and follow-up will follow standard protocols. In the further clinical course, the patients in the study group treated with PLGA implants spare a subsequent operation for implant removal after 4-8 weeks. The results of different surgeries will be compared based on several criteria.

Conditions

  • Fracture Wrist

Interventions

PROCEDURE

Distal radial metaphyseal fracture fixation with percutaneous K-wires

Pediatric distal metaphyseal fractures which are severly displaced will be operated with percutaneous K-wires..

PROCEDURE

Distal radial and/or ulnar metaphyseal fracture fixation with bidegradable PLGA-based (Activa Im-Nail) implants

Pediatric distal metaphyseal radial and /or ulnar fractures which are severly displaced will be operated with percutaneous bidegradable PLGA-based (Activa Im-Nail) implants.

Sponsors & Collaborators

  • Péterfy Sándor Hospital

    lead OTHER

Principal Investigators

  • Marcell Varga, PhD · Péterfy Hospital, National Trauma Center,Budapest

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2022-03-31
Completion
2022-10-31

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04848818 on ClinicalTrials.gov