Human Bone Graft in Epiphysiodesis
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|ClinicalTrials.gov Identifier: NCT04067895|
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : March 11, 2021
|Condition or disease||Intervention/treatment|
|Leg Length Differences Primordial Gigantism||Procedure: epiphysiodesis|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|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 2021|
|Estimated Study Completion Date :||September 2022|
human bone graft screw
human bone graft screws will be used during the 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.
- 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.
- evaluation of swelling [ Time Frame: 1 year ]Is a swelling in the surgery area visible? NO/MILD/MODERATE/SEVERE
- evaluation of wound healing disorder [ Time Frame: 1 year ]Is a disorder of the wound healing recognizable? NO/MILD/MODERATE/SEVERE
- evaluation of hematoma [ Time Frame: 1 year ]Is a hematoma in the surgery area visible? NO/MILD/MODERATE/SEVERE
- 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.
- 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.
- 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.
- 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.
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
|Contact: Catharina Chiari, Dr.||+43 1 40400 ext email@example.com|
|Contact: Sandra Hacker, MSc||+43 1 40400 ext firstname.lastname@example.org|
|General Hospital Vienna||Recruiting|
|Vienna, Austria, 1090|
|Contact: Sandra Hacker, MSc +43 1 40400 ext 40900 email@example.com|
|Principal Investigator: Catharina Chiari, Prof. MD|