Human Bone Graft in Epiphysiodesis

Multi-center Observational Study on the Use of a Human Bone Graft in Epiphysiodesis

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.

Study Overview

• Status: Recruiting
• Conditions: Leg Length Differences; Primordial Gigantism
• Intervention / Treatment: Procedure: epiphysiodesis

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Catharina Chiari, Dr.; Phone Number: 40900 +43 1 40400; Email: catharina.chiari@meduniwien.ac.at
• Study Contact Backup: Name: Sandra Hacker, MSc; Phone Number: 40900 +43 1 40400; Email: sandra.hacker@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • General Hospital Vienna
    • Contact: Sandra Hacker, MSc; Phone Number: 40900 +43 1 40400; Email: sandra.hacker@meduniwien.ac.at
    • Principal Investigator: Catharina Chiari, Prof. MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
human bone graft screw; human bone graft screws will be used during the epiphysiodesis	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of surgical revisions	Was a surgical revision done postoperatively? YES/NO	1 year
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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction (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 = very satisfied - 100mm = not satisfied at all). A higher score indicates less satisfaction.	1 year
International Knee Documentation Committee Subjective Knee Form (IKDC Score)	The IKDC Score contains 19 questions (7 questions for symptomatology, 10 concerning function, 2 about sport activity). The lowest function level or the highest symptom level receives the score value 1. The highest function level or the lowest symptom level is given the number n according to the number n of possible answers. With the exception of question 10 "Functioning before knee injury", the remaining 18 response points are summed up. This gives the "raw sum". The lowest possible score is 18 and the maximum possible score is 87. The raw sum is converted into a scale of 0 to 100 using the following formula: ((raw score - lowest possible score)/score range)*100. 0 points mean the greatest possible impairment, while 100 points mean complete freedom from symptoms and functioning. The IKDC score can only be calculated if at least 16 of the 18 questions have been answered.	1 year
evaluation of swelling	Is a swelling in the surgery area visible? NO/MILD/MODERATE/SEVERE	1 year
evaluation of wound healing disorder	Is a disorder of the wound healing recognizable? NO/MILD/MODERATE/SEVERE	1 year
evaluation of hematoma	Is a hematoma in the surgery area visible? NO/MILD/MODERATE/SEVERE	1 year
Knee Outcome Survey - Activities of Daily Living Scale (KOS-ADL)	The KOS ADL score includes 14 questions and is divided in 2 subscales, symptoms (6 items, max. score 30) and functional restrictions (8 items, max. score 40). The scores of the answers range from 0 to 5 points. 0 points mean no impairment of everyday activities, while 5 points represent the greatest possible impairment. All points are summed up. From this, the KOS-ADL score is calculated as the proportion of the total response points from the possible maximum score (70) in percent. KOS ADL Score [%] = ( symptoms pts. + functional restrictions pts.)*100/70. The percentage ranges from 0-100%. 0% means no impairment, while 100% represents the greatest possible impairment.	1 year
Revised questionnaire to assess Health-Related Quality of Life in children and adolescents (KINDL)	The KINDL is a generic instrument for assessing Health-Related Quality of Life in children and adolescents aged 3 years and older. There are 3 versions available for different age groups: Kiddy-KINDL 4-6 years, Kid-KINDL 7-13 years, Kiddo-KINDL 14-17 years. The questionnaires used in this study (Kid-KINDL and Kiddo-KINDL) provide 24 Likert-scaled items associated with 6 dimensions: physical well-being ,emotional well-being, self-esteem, family, friends, and school. All versions also contain an additional section 'disease' with 6 items. They can be completed in case of illness or hospitalization. The items and sub-scales are calculated according to the KINDL manual and a higher score corresponds to a higher health-related quality of life.	1 year

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Surgebright Gmbh

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 6, 2019
• Primary Completion (ANTICIPATED): September 1, 2023
• Study Completion (ANTICIPATED): September 1, 2024

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (ACTUAL): August 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: epiphysiodesis; human bone graft screw; leg length inequality; primordial gigantism
• Additional Relevant MeSH Terms: Endocrine System Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Endocrine; Hyperpituitarism; Pituitary Diseases; Bone Diseases, Developmental; Gigantism
• Other Study ID Numbers: EP1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No