Bioresorbable Intramedullary Nailing of Forearm Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2024-09-30

Brief Summary

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The Activa IM-Nail™ is used in the fixation of forearm fractures with cast to achieve a level of reduction and stabilisation that is appropriate to the age of the child. The post-market clinical follow-up study will be performed to identify the residual risk related to re-fracture and to determine its impact to the risk/benefit ratio of Activa IM-Nail™.

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Detailed Description

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Residual risk related to re-fracture rate will be addressed by this PMCF study. The research question is, if the re-fracture risk with Activa IM-nail is in line with the other treatment methods, namely ESIN.

Primary objective: will be to assess clinical outcome by determining re-fracture rate of all treated patients, difference of re-fracture rate depending on the fracture type determined by X-ray (e.g. greenstick vs. non-greenstick fracture), subject's age, BMI, surgical technique, immobilization time and bony union formation.

Conditions

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Forearm Fracture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MRI scan 1st and 2nd year

Additionally to routinely follow up, there will be an MRI scan of enrolled patients after one and two years in some of the study sites

Group Type OTHER

MRI Scan

Intervention Type OTHER

MRI scan

Interventions

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MRI Scan

MRI scan

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diaphyseal forearm fractures (radius or ulna or both)
* Patients from 3 years to under 13 years, but the age limits depend on the biological development of the child and in addition

Exclusion Criteria

* multifragmentary fractures, metaphyseal and epiphyseal fractures
* Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection, or where a patient's cooperation cannot be guaranteed.

Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No