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NCT Number: NCT03885960

Perthes Disease in Norway

Calvé-Legg-Perthes disease (CLP) is a hip disease in children whose femoral head becomes completely or partially necrotic. The disease is most common in five-six years of age. The femoral head is gradually deformed during the active stages of the disease (5-7 years). By healing, the hip joint shape will vary from an approximately normal joint to pronounced changes, the hip joint will be irregular. Such a hip joint is available for osteoarthritis. The purpose of this study is to map the function of the hip, the patient's quality of life and especially the risk factors that affect the outcome of the previous CLP. A nationwide prospective study of CLP was conducted between 1996 and 2000. All children with newly diagnosed Perthes disease (425) were registered. The current study will follow up all these patients with an average follow-up of 20 years. Radiological endpoints are evidence of hip osteoarthritis. Patient-reported outcomes (PROMS) should illuminate the function of the hip and quality of life.

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Key information

Conditions

Legg Calve Perthes Disease Arthritis Bone Diseases Femur Head Necrosis Joint Diseases Legg-Calve-Perthes Disease Musculoskeletal Diseases Osteoarthritis Osteonecrosis Rheumatic Diseases

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital - Rikshospitalet

Oslo, Sognsvannsveien 20, 0372, Norway

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject was diagnosed with Perthes disease between 1996 and 2000 in Norway

Exclusion criteria

  • Death upon follow up
  • Other skeletal dysplasia
  • Patient not able to give consent,

Treatment and study plan

Primary outcomes

  1. Hip osteoarthritis

    Time frame: an average of 20 years follow-up

    radiographic measurement of weight bearing zone

  2. Hip function

    Time frame: an average of 20 years follow-up

    PROMS HOOS

Secondary outcomes

  1. Hip ROM

    Time frame: an average of 20 years follow-up

    functional test of range of motion of the hip

  2. Gluteal muscle strength

    Time frame: an average of 20 years follow-up

    Trendelenburg test

  3. Hip strength

    Time frame: an average of 20 years follow-up

    single leg hop test - 6 meters

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Sophies Minde Ortopedi

Registry information

Official study title

A Prospective Nationwide Study of Perthes' Disease in Norway: Functional and Radiographic Outcomes at a Mean Follow-up of Twenty Years

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Mar 22, 2019
Registry last updated
Mar 18, 2025

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.

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