NCT04067895

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2019

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

4.1 years

First QC Date

August 22, 2019

Last Update Submit

August 23, 2022

Conditions

Leg Length DifferencesPrimordial Gigantism

Keywords

human bone graft screwepiphysiodesisleg length inequalityprimordial gigantism

Outcome Measures

Primary Outcomes (9)

  • formation of a bone bridge

    based on x-rays or MRI: Is as formation of a bone bridge visible? YES/NO How many millimeters? mm

    1 year

  • incidence of surgical revisions

    Was a surgical revision done postoperatively? YES/NO

    1 year

  • incidence of additional surgery

    Was an additional surgery necessary to stop growth? YES/NO; Which one?

    1 year

  • incidence of cracking of the screw

    based on x-rays or MRI: Is a crack of the screw visible? YES/NO

    1 year

  • incidence of a dislocation of the screw

    based on x-rays or MRI: Is the screw dislocated? YES/NO

    1 year

  • incidence of postoperative inflammatory complications

    Is a postoperative inflammatory complication recognizable? YES/NO

    1 year

  • cystic brightening around the screw

    based on x-rays or MRI: Is a cystic brightening around the screw visible? YES/NO

    1 year

  • sclerosing around the screw

    based on x-rays or MRI: Is a sclerosis around the screw visible? YES/NO

    1 year

  • evaluation of postoperative pain (VAS)

    The visual analogue scale (VAS) is a vertical line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extremes (0mm = no pain - 100mm = worst imaginable pain). A higher score indicates more pain.

    1 year

Secondary Outcomes (7)

  • evaluation of swelling

    1 year

  • evaluation of wound healing disorder

    1 year

  • evaluation of hematoma

    1 year

  • patient satisfaction (VAS)

    1 year

  • Knee Outcome Survey - Activities of Daily Living Scale (KOS-ADL)

    1 year

  • +2 more secondary outcomes

Study Arms (1)

human bone graft screw

human bone graft screws will be used during the epiphysiodesis

Procedure: epiphysiodesis

Interventions

epiphysiodesisPROCEDURE

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.

human bone graft screw

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients from all participating sites scheduled for an epiphysiodesis with humanm bone graft screws get information about this observational study and have the possibiltiy to participate.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Leg Length Inequality

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Catharina Chiari, Dr.

CONTACT

+43 1 40400catharina.chiari@meduniwien.ac.at

Sandra Hacker, MSc

CONTACT

+43 1 40400sandra.hacker@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ. Prof. Dr. Catharina Chiari, MSc

Study Record Dates

First Submitted

August 22, 2019

First Posted

August 28, 2019

Study Start

August 6, 2019

Primary Completion

September 1, 2023

Study Completion

September 1, 2024

Last Updated

August 24, 2022

Record last verified: 2022-08

Locations

AU(1)