Perthes Disease in Norway

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Legg Calve Perthes Disease

• Study Type: Observational
• Enrollment (Anticipated): 425

Contacts and Locations

Study Locations

• Norway
  • Sognsvannsveien 20
    • Oslo, Sognsvannsveien 20, Norway, 0372
      • Oslo University Hospital - Rikshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients which have been diagnosed with Perthes disease in between 1996 and 2000 in Norway were registered and follow at least 5 years after diagnosis. All hospitals throughout Norway with orthopaedic service were included in the registration. Our study is a 20 years follow-up of the original study.

Description

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,

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip osteoarthritis	radiographic measurement of weight bearing zone	an average of 20 years follow-up
Hip function	PROMS HOOS	an average of 20 years follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip ROM	functional test of range of motion of the hip	an average of 20 years follow-up
Gluteal muscle strength	Trendelenburg test	an average of 20 years follow-up
Hip strength	single leg hop test - 6 meters	an average of 20 years follow-up

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Sophies Minde Foundation
• Investigators: Principal Investigator: Stefan Huhnstock, Phd, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ANTICIPATED): December 31, 2025
• Study Completion (ANTICIPATED): December 31, 2025

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (ACTUAL): March 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: osteoarthritis; quality of life; function; Hip; Perthes; LCPD
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Femur Head Necrosis; Osteonecrosis; Legg-Calve-Perthes Disease
• Other Study ID Numbers: 2018/1924

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No