Swedish Age Assessment Study

Not Applicable

Completed

• Conditions: Age Determination by Skeleton
• Interventions: Diagnostic Test: MRI scan of knee, ankle and wrist

• Registration Number: NCT03242811
• Lead Sponsor: Berit Larsson

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

Study Timeline

• Study Start: 2017-06-16
• Study First Submitted: 2017-07-23
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-08
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-05
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 958

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Examination by MRI	MRI scan of knee, ankle and wrist	MRI scan of knee, ankle and wrist

Primary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (2)

Karolinska Institute; 🇸🇪 Stockholm, Sweden

Blekinge Institute of Technology; 🇸🇪 Karlskrona, Sweden