Clinical trial NCT03242811: Swedish Age Assessment Study
Official title: Swedish Age Assessment Study -SAAS Study to Deepen the Knowledge of Magnetic Camera Examinations as a Method for Medical Age Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age Determination by Skeleton
Keywords: Medical age assessment
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Blekinge Institute of Technology
name: Ministry of Health and Social Affairs, Sweden
name: Karolinska Institutet
First posted: 2017-08-08
Enrollment: 958
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: It is important that asylum seekers should have as accurate age assessment as possible and that children's fundamental rights are met by choosing methods based on best available knowledge. The aim is to provide, on the basis of best available knowledge, suggestions for methods of medical age assessment of whether a person is over or under 18 years of age.

The primary issue is to investigate whether five selected growth zones in knee joint, ankle and wrist individually or in combination can better determine the 18-year limit compared with previous research.

Detailed description: Swedish Age Assessment study is conducted with the aim of

* Deepening the knowledge of age-assessment methodology with magnetic camera examinations among born and registered in Sweden aged 14.0 through 21.5 years
* With a magnetic camera, investigate whether five selected growth zones in the knee joint and ankle joint (distal femur, proximal tibia, distal tibia and calcaneus) and distal radius (wrist) individually or in combination can better determine the 18-year limit compared with previous research
* To investigate how gender and growing environment can affect the end of growth zones

Eligibility criteria: Inclusion Criteria:

* Healthy children / young adults without prior illness (such as asthma, growth hormone treatment, prolonged peroral cortisone treatment, cancer treatment, diabetes, rheumatic disease) that may have affected growth can be included in the study.

Exclusion Criteria:

* Children or adolescents with ongoing drug treatment for chronic disease.
* Contraindication against MRI examination
* Pregnancy

Primary outcomes:
measure: Number of participants with correctly classified age (below or above 18 years) when 5 different growth zones in the knee, ankle and wrist are examined by MRI and analysed individually and in combination to determine the maturity.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Karlskrona
country: Sweden
facility: Blekinge Institute of Technology
city: Stockholm
country: Sweden
facility: Karolinska Institute
Study officials:
affiliation: Karolinska Institutet
name: Sandra Diaz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Blekinge Institute of Technology
name: Johan Sanmartin Berglund, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ministry of Health and Social Affairs, Sweden
name: Carl-Erik Flodmark, MD, PhD
role: STUDY_DIRECTOR
References: