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 Type
OBSERVATIONAL
Enrollment
20
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.
General Hospital Vienna
Vienna, Austria
RECRUITINGformation of a bone bridge
based on x-rays or MRI: Is as formation of a bone bridge visible? YES/NO How many millimeters? mm
Time frame: 1 year
incidence of surgical revisions
Was a surgical revision done postoperatively? YES/NO
Time frame: 1 year
incidence of additional surgery
Was an additional surgery necessary to stop growth? YES/NO; Which one?
Time frame: 1 year
incidence of cracking of the screw
based on x-rays or MRI: Is a crack of the screw visible? YES/NO
Time frame: 1 year
incidence of a dislocation of the screw
based on x-rays or MRI: Is the screw dislocated? YES/NO
Time frame: 1 year
incidence of postoperative inflammatory complications
Is a postoperative inflammatory complication recognizable? YES/NO
Time frame: 1 year
cystic brightening around the screw
based on x-rays or MRI: Is a cystic brightening around the screw visible? YES/NO
Time frame: 1 year
sclerosing around the screw
based on x-rays or MRI: Is a sclerosis around the screw visible? YES/NO
Time frame: 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.
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Time frame: 1 year
evaluation of swelling
Is a swelling in the surgery area visible? NO/MILD/MODERATE/SEVERE
Time frame: 1 year
evaluation of wound healing disorder
Is a disorder of the wound healing recognizable? NO/MILD/MODERATE/SEVERE
Time frame: 1 year
evaluation of hematoma
Is a hematoma in the surgery area visible? NO/MILD/MODERATE/SEVERE
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year