Clinical trial NCT04067895: Human Bone Graft in Epiphysiodesis
Official title: Multi-center Observational Study on the Use of a Human Bone Graft in Epiphysiodesis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Leg Length Differences
Primordial Gigantism
Keywords: human bone graft screw
epiphysiodesis
leg length inequality
primordial gigantism
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Surgebright Gmbh
First posted: 2019-08-28
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: formation of a bone bridge
timeFrame: 1 year
measure: incidence of surgical revisions
timeFrame: 1 year
measure: incidence of additional surgery
timeFrame: 1 year
measure: incidence of cracking of the screw
timeFrame: 1 year
measure: incidence of a dislocation of the screw
timeFrame: 1 year
measure: incidence of postoperative inflammatory complications
timeFrame: 1 year
measure: cystic brightening around the screw
timeFrame: 1 year
measure: sclerosing around the screw
timeFrame: 1 year
measure: evaluation of postoperative pain (VAS)
timeFrame: 1 year
Secondary outcomes:
measure: evaluation of swelling
timeFrame: 1 year
measure: evaluation of wound healing disorder
timeFrame: 1 year
measure: evaluation of hematoma
timeFrame: 1 year
measure: patient satisfaction (VAS)
timeFrame: 1 year
measure: Knee Outcome Survey - Activities of Daily Living Scale (KOS-ADL)
timeFrame: 1 year
measure: International Knee Documentation Committee Subjective Knee Form (IKDC Score)
timeFrame: 1 year
measure: Revised questionnaire to assess Health-Related Quality of Life in children and adolescents (KINDL)
timeFrame: 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: General Hospital Vienna
Study officials:
References: