Leg Length Differences Clinical Trial
Official title:
Multi-center Observational Study on the Use of a Human Bone Graft in Epiphysiodesis
| NCT number | NCT04067895 |
| Other study ID # | EP1 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 6, 2019 |
| Est. completion date | September 2024 |
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.
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | September 2024 |
| Est. primary completion date | September 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 10 Years to 18 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | General Hospital Vienna | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna | Surgebright Gmbh |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | incidence of surgical revisions | Was a surgical revision done postoperatively? YES/NO | 1 year | |
| Primary | incidence of additional surgery | Was an additional surgery necessary to stop growth? YES/NO; Which one? | 1 year | |
| Primary | incidence of cracking of the screw | based on x-rays or MRI: Is a crack of the screw visible? YES/NO | 1 year | |
| Primary | incidence of a dislocation of the screw | based on x-rays or MRI: Is the screw dislocated? YES/NO | 1 year | |
| Primary | incidence of postoperative inflammatory complications | Is a postoperative inflammatory complication recognizable? YES/NO | 1 year | |
| Primary | cystic brightening around the screw | based on x-rays or MRI: Is a cystic brightening around the screw visible? YES/NO | 1 year | |
| Primary | sclerosing around the screw | based on x-rays or MRI: Is a sclerosis around the screw visible? YES/NO | 1 year | |
| Primary | 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 | evaluation of swelling | Is a swelling in the surgery area visible? NO/MILD/MODERATE/SEVERE | 1 year | |
| Secondary | evaluation of wound healing disorder | Is a disorder of the wound healing recognizable? NO/MILD/MODERATE/SEVERE | 1 year | |
| Secondary | evaluation of hematoma | Is a hematoma in the surgery area visible? NO/MILD/MODERATE/SEVERE | 1 year | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |