Completed

NCT Number: NCT03242811

Swedish Age Assessment Study

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.

Completed

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Key information

Conditions

Age Determination by Skeleton

Age range

14 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blekinge Institute of Technology, Karlskrona, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI scan of knee, ankle and wrist

Diagnostic Test

At the day of the intervention, the subject is informed about the study by a nurse and provides written informed consent.

Girls must leave urine tests to rule out pregnancy. The questionnaire for the study is answered by the subject and weight and length are measured. The subject is asked to self-assess his/her puberty.

After detailed information on how a magnetic camera examination is carried out, an examination of five selected growth zones (knee joint, ankle joint including heel leg and wrist) is performed using 1.5 Tesla magnetic camera with dedicated cartilage sequence.

Other names: Self assessment of puberty by Tanner scale, Questionnaire on socioeconomics

Primary outcomes

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.

Time frame: 1 day

With 1.5 Tesla magnetic camera with dedicated cartilage sequence, selected growth zones will be investigated: knee joint, ankle joint including heel leg and wrist. The non-dominant body half will be investigated. In order to evaluate the growth zone with the highest precision, we have chosen T2-weighted gradient-recalled echo sequence, called mFFE / MERGE® / MEDIC® by various suppliers. The sequence is used in the clinical practice to assess various types of abnormalities in the cartilage. Two independent and blinded child radiologists shall examine MR images of 5 growth zones of each participant. All sections of each growth zone are to be examined and the cut is selected which shows the highest degree of closing / maturity for grading. Each growth zone will be examined and classified as being mature or non-mature.

Sponsors and collaborators

Lead sponsor

Berit Larsson

Other

Collaborators

Blekinge Institute of Technology
Karolinska Institutet
Ministry of Health and Social Affairs, Sweden

Registry information

Official study title

Swedish Age Assessment Study -SAAS Study to Deepen the Knowledge of Magnetic Camera Examinations as a Method for Medical Age Assessment

Acronym: SAAS

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Aug 8, 2017
Registry last updated: Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.