Perthes Disease in Norway

Legg Calve Perthes Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03885960
• Other study ID #: 2018/1924
• Status: Enrolling by invitation
• Start date: November 1, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2022
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 425
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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,

Related Conditions & MeSH terms

• Legg Calve Perthes Disease

Locations

Country	Name	City	State
Norway	Oslo University Hospital - Rikshospitalet	Oslo	Sognsvannsveien 20

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Sophies Minde Foundation

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hip osteoarthritis	radiographic measurement of weight bearing zone	an average of 20 years follow-up
Primary	Hip function	PROMS HOOS	an average of 20 years follow-up
Secondary	Hip ROM	functional test of range of motion of the hip	an average of 20 years follow-up
Secondary	Gluteal muscle strength	Trendelenburg test	an average of 20 years follow-up
Secondary	Hip strength	single leg hop test - 6 meters	an average of 20 years follow-up