Human Bone Graft in Epiphysiodesis

NCT ID: NCT04067895

Last Updated: 2022-08-24

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

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-06

Study Completion Date

2024-09-30

Brief Summary

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This observational study is to document the application of human bone graft in the surgical treatment (epiphysiodesis) of leg length discrepancy or primordial gigantism and its subsequent healing process.

Detailed Description

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Conditions

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Leg Length Differences Primordial Gigantism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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human bone graft screw

human bone graft screws will be used during the epiphysiodesis

epiphysiodesis

Intervention Type PROCEDURE

All patients undergo surgical treatment of leg lengths discrepancies or primordial gigantism. Human bone graft screws will be used to stop the distraction of the growth plate.

Interventions

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epiphysiodesis

All patients undergo surgical treatment of leg lengths discrepancies or primordial gigantism. Human bone graft screws will be used to stop the distraction of the growth plate.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Planned epiphysiodesis to stop the growing of a bone indicated by leg length discrepancies or primordial gigantism
* Age 10-18 years
* Written consent to participate in the study after previous written and oral education (additional consent for the participation of minors in the study after prior written and oral education by at least one parent)

Exclusion Criteria

* Insufficient knowledge of the german language
* Foreseeable compliance issues
* Neoplastic diseases, malignant bone tumors, rheumatoid arthritis
* Patients with non-treated pre-existing conditions, which could be the cause of leg length differences
* Active osteomyelitis
* Ulcerations in the area of the skin of the surgical area
* Immunosuppressive drugs that can not be discontinued
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Surgebright Gmbh

INDUSTRY

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Catharina Chiari

Univ. Prof. Dr. Catharina Chiari, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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General Hospital Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Catharina Chiari, Dr.

Role: CONTACT

+43 1 40400 ext. 40900

Sandra Hacker, MSc

Role: CONTACT

+43 1 40400 ext. 40900

Facility Contacts

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Sandra Hacker, MSc

Role: primary

+43 1 40400 ext. 40900

Other Identifiers

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EP1

Identifier Type: -

Identifier Source: org_study_id

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