Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Human Bone Graft in Epiphysiodesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067895
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : February 20, 2020
Sponsor:
Collaborator:
surgebright GmbH
Information provided by (Responsible Party):
Catharina Chiari, Medical University of Vienna

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.

Condition or disease Intervention/treatment
Leg Length Differences Primordial Gigantism Procedure: epiphysiodesis

Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-center Observational Study on the Use of a Human Bone Graft in Epiphysiodesis
Actual Study Start Date : August 6, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

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.




Primary Outcome Measures :
  1. 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

  2. incidence of surgical revisions [ Time Frame: 1 year ]
    Was a surgical revision done postoperatively? YES/NO

  3. incidence of additional surgery [ Time Frame: 1 year ]
    Was an additional surgery necessary to stop growth? YES/NO; Which one?

  4. 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

  5. incidence of a dislocation of the screw [ Time Frame: 1 year ]
    based on x-rays or MRI: Is the screw dislocated? YES/NO

  6. incidence of postoperative inflammatory complications [ Time Frame: 1 year ]
    Is a postoperative inflammatory complication recognizable? YES/NO

  7. 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

  8. sclerosing around the screw [ Time Frame: 1 year ]
    based on x-rays or MRI: Is a sclerosis around the screw visible? YES/NO

  9. 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.


Secondary Outcome Measures :
  1. evaluation of swelling [ Time Frame: 1 year ]
    Is a swelling in the surgery area visible? NO/MILD/MODERATE/SEVERE

  2. evaluation of wound healing disorder [ Time Frame: 1 year ]
    Is a disorder of the wound healing recognizable? NO/MILD/MODERATE/SEVERE

  3. evaluation of hematoma [ Time Frame: 1 year ]
    Is a hematoma in the surgery area visible? NO/MILD/MODERATE/SEVERE

  4. patient satisfaction (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 = very satisfied - 100mm = not satisfied at all). A higher score indicates less satisfaction.

  5. Knee Outcome Survey - Activities of Daily Living Scale (KOS-ADL) [ Time Frame: 1 year ]

    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.


  6. International Knee Documentation Committee Subjective Knee Form (IKDC Score) [ Time Frame: 1 year ]
    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.

  7. Revised questionnaire to assess Health-Related Quality of Life in children and adolescents (KINDL) [ Time Frame: 1 year ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067895


Contacts
Layout table for location contacts
Contact: Catharina Chiari, Dr. +43 1 40400 ext 40900 catharina.chiari@meduniwien.ac.at
Contact: Sandra Hacker, MSc +43 1 40400 ext 40900 sandra.hacker@meduniwien.ac.at

Locations
Layout table for location information
Austria
General Hospital Vienna Recruiting
Vienna, Austria, 1090
Contact: Sandra Hacker, MSc    +43 1 40400 ext 40900    sandra.hacker@meduniwien.ac.at   
Principal Investigator: Catharina Chiari, Prof. MD         
Sponsors and Collaborators
Medical University of Vienna
surgebright GmbH
Layout table for additonal information
Responsible Party: Catharina Chiari, Univ. Prof. Dr. Catharina Chiari, MSc, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04067895    
Other Study ID Numbers: EP1
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Catharina Chiari, Medical University of Vienna:
human bone graft screw
epiphysiodesis
leg length inequality
primordial gigantism
Additional relevant MeSH terms:
Layout table for MeSH terms
Gigantism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hyperpituitarism
Pituitary Diseases
Endocrine System Diseases