Leg Length DifferencesNCT04067895
Human Bone Graft in Epiphysiodesis
An observational study of Leg Length Differences and Primordial Gigantism, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Leg Length Differences, Primordial Gigantism
- What is being tested?
- epiphysiodesis
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 6 Aug 2019to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
General Hospital Vienna
Vienna, 1090
Sandra Hacker, MSc, +43 1 40400 ext. 40900, sandra.hacker@meduniwien.ac.at
Catharina Chiari, Prof. MD
About this study
Official title: 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.
- Conditions
- Leg Length Differences, Primordial Gigantism
- Being tested
- epiphysiodesis
- Keywords
- human bone graft screw, epiphysiodesis, leg length inequality, primordial gigantism
- Medical subject headings
- Leg Length Inequality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epiphysiodesisProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| human bone graft screw | human bone graft screws will be used during the epiphysiodesis Receives: Procedure: epiphysiodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
incidence of surgical revisions
Was a surgical revision done postoperatively? YES/NO
Measured: 1 year
incidence of additional surgery
Was an additional surgery necessary to stop growth? YES/NO; Which one?
Measured: 1 year
incidence of cracking of the screw
based on x-rays or MRI: Is a crack of the screw visible? YES/NO
Measured: 1 year
incidence of a dislocation of the screw
based on x-rays or MRI: Is the screw dislocated? YES/NO
Measured: 1 year
incidence of postoperative inflammatory complications
Is a postoperative inflammatory complication recognizable? YES/NO
Measured: 1 year
cystic brightening around the screw
based on x-rays or MRI: Is a cystic brightening around the screw visible? YES/NO
Measured: 1 year
sclerosing around the screw
based on x-rays or MRI: Is a sclerosis around the screw visible? YES/NO
Measured: 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.
Measured: 1 year
Secondary outcomes (7)
evaluation of swelling
Is a swelling in the surgery area visible? NO/MILD/MODERATE/SEVERE
Measured: 1 year
evaluation of wound healing disorder
Is a disorder of the wound healing recognizable? NO/MILD/MODERATE/SEVERE
Measured: 1 year
evaluation of hematoma
Is a hematoma in the surgery area visible? NO/MILD/MODERATE/SEVERE
Measured: 1 year
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start6 Aug 2019
- Primary completionSep 2023 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg Length DifferencesStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Surgebright Gmbh
- Responsible party
- Principal investigator, Catharina Chiari, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067895
- Sponsor's protocol ID
- EP1
- Status last verified
- Aug 2022
- First submitted
- 22 Aug 2019
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Observational Study on the Use of a Human Bone Graft in Epiphysiodesis
- ClinicalTrials.gov ID
- NCT04067895
- Acronym / sponsor ID
- EP1
- Conditions
- Leg Length Differences, Primordial Gigantism
- Keywords
- human bone graft screw, epiphysiodesis, leg length inequality, primordial gigantism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Surgebright Gmbh
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| human bone graft screw | – | Procedure: epiphysiodesishuman bone graft screws will be used during the epiphysiodesis |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epiphysiodesisAll 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. | Procedure or surgery | human bone graft screw |
Primary outcome
formation of a bone bridge
Time frame: 1 year
based on x-rays or MRI: Is as formation of a bone bridge visible? YES/NO How many millimeters? mm
incidence of surgical revisions
Time frame: 1 year
Was a surgical revision done postoperatively? YES/NO
incidence of additional surgery
Time frame: 1 year
Was an additional surgery necessary to stop growth? YES/NO; Which one?
incidence of cracking of the screw
Time frame: 1 year
based on x-rays or MRI: Is a crack of the screw visible? YES/NO
incidence of a dislocation of the screw
Time frame: 1 year
based on x-rays or MRI: Is the screw dislocated? YES/NO
incidence of postoperative inflammatory complications
Time frame: 1 year
Is a postoperative inflammatory complication recognizable? YES/NO
cystic brightening around the screw
Time frame: 1 year
based on x-rays or MRI: Is a cystic brightening around the screw visible? YES/NO
sclerosing around the screw
Time frame: 1 year
based on x-rays or MRI: Is a sclerosis around the screw visible? YES/NO
evaluation of postoperative pain (VAS)
Time frame: 1 year
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.
7 secondary outcomes
evaluation of swelling
Time frame: 1 year
evaluation of wound healing disorder
Time frame: 1 year
evaluation of hematoma
Time frame: 1 year
patient satisfaction (VAS)
Time frame: 1 year
Knee Outcome Survey - Activities of Daily Living Scale (KOS-ADL)
Time frame: 1 year
International Knee Documentation Committee Subjective Knee Form (IKDC Score)
Time frame: 1 year
Revised questionnaire to assess Health-Related Quality of Life in children and adolescents (KINDL)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leg Length Differences and Primordial Gigantism, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catharina Chiari, Dr. (+43 1 40400 ext. 40900, catharina.chiari@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
formation of a bone bridge (time frame: 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.