Use of the Bioabsorbable Activa IM-Nail™ in Pediatric Dia... | NCT04941612

Studies
Use of the Bioabsorbable Activa IM-Nail™ in Pediatric Diaphyseal Forearm Fractures

NCT04941612

Sponsor

Children's Fractures Interest Group, Denmark

Status

Unknown status

Last Update Posted

Jun 28, 2021Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Fracture Fixation, Intramedullary
Forearm Fracture
Fracture Healing
Child, Only
Implant Complication

Interventions

Activa IM-Nail

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 25, 2021Actual

Primary Completion Date

Aug 31, 2023Estimated

Completion Date

May 25, 2025Estimated

First Submitted Date

May 24, 2021

First Submission Date that Met QC Criteria

Jun 23, 2021

First Posted Date

Jun 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2021

Last Update Posted Date

Jun 28, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Morten Jon Andersen, Consultant Orthopedic Surgeon, Children's Fractures Interest Group, DenmarkPrincipal Investigator

Lead Sponsor

Children's Fractures Interest Group, DenmarkOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Background

Pediatric diaphyseal forearm fractures are common and one of the most frequent reasons for orthopedic care. Fractures in need of surgery are often treated with metal Elastic Stable Intramedullary Nails (ESIN). Nail removal after 6-12 months is generally advocated. Surgical hardware removal has few complications; however, it is a substantial burden on the child, the family and healthcare economy. Bioabsorbable Intramedullary Nails (BIN) have been developed for the same indications as metal ESIN. The use of bioabsorbable implants would deem hardware removal unnecessary and relieve the child of further surgery and reduce healthcare costs.

Methods

The investigators aim to recruit all children in the catchment area of Herlev and Gentofte University Hospital (Copenhagen, Denmark) with acute unstable diaphyseal forearm fractures. Participants will be operated with BIN and followed consecutively for 2 years with interim analysis of data after 6 months. The investigators will report radiological healing using the Radiographic Union Score (RUS) 3 months after surgery together with any adverse events during follow-up.

Discussion

This study will provide important preliminary data and asses the feasibility of using the bioabsorbable Activa IM-Nail™ in pediatric diaphyseal forearm fractures. This study is a pilot study for initiating an RCT comparing BIN to metal ESIN hypothesizing that BIN is not an inferior treatment.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Activa IM-Nail	Experimental	Activa IM-Nail	Device: Activa IM-Nail

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Activa IM-Nail	Device	PLGA bioabsorbable intramedullary nail	Activa IM-Nail

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiographic Union Score (RUS)	RUS is a score derived from assessing AP and lateral radiographs. Each bone cortex (anterior, posterior, medial and lateral) is assigned a score of 1 to 3. A cortex with a visible fracture line and no callus is given a score of 1, a cortex with callus but a visible fracture line is scored as 2 and a cortex with bridging callus and no visible fracture line is scored as 3. Scores are added to give a minimum score of 4 (definitely not healed) and a maximum of 12 (definitely healed). 12 is best.	3 months

Secondary Outcomes

Measure	Description	Time Frame
Faces Pain Scale - Revised (FPS-R)	To measure the outcome of pain in children below 8 years of age. Pain evaluated by the child selecting 1 of 6 faces that represents their feeling of pain. Faces are scored 0, 2, 4, 6, 8 or 10. Scale 0-10 with 2 point increments. 0 = no pain, 10= very much pain. 0 is best.	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute traumatic diaphyseal forearm fracture of the radius, ulna or both
Fractures need to be complete (not unicortical or green stick)
Displaced more than 50% of bone width or angulated more than 10° in any plane or irreducible or unstable after reduction

Exclusion Criteria:

We exclude patients

with fractures that are well managed conservatively (undisplaced or minimally displaced)
with previous ipsilateral forearm fracture
with fractures unsuited for intramedullary nailing (e.g. multifragmentary, metaphyseal or epiphyseal)
with fractures with ipsilateral wrist or elbow involvement (e.g. Monteggia or Galeazzi variants)
unable to participate in follow-up
with existing bone pathology (e.g. tumor, osteogenesis imperfecta, degenerative disease)
in whom internal fixation is otherwise contraindicated (e.g. active or potential infection)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Morten J Andersen, MD	Contact	004538681479		mortenjonandersen@gmail.com

Overall Officials

Name	Affiliation	Role
Morten J Andersen, MD		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herlev and Gentofte University Hospital	Recruiting	Herlev	Capital Region	2730	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided