NCT03885960

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

7.2 years

First QC Date

January 9, 2019

Last Update Submit

March 17, 2025

Conditions

Keywords

Hipfunctionquality of lifeosteoarthritisPerthesLCPD

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Hip ROM

    an average of 20 years follow-up

  • Gluteal muscle strength

    an average of 20 years follow-up

  • Hip strength

    an average of 20 years follow-up

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital - Rikshospitalet

Oslo, Sognsvannsveien 20, 0372, Norway

Location

MeSH Terms

Conditions

Legg-Calve-Perthes DiseaseOsteoarthritis

Condition Hierarchy (Ancestors)

Femur Head NecrosisOsteonecrosisBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesRheumatic Diseases

Study Officials

  • Stefan Huhnstock, Phd

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 9, 2019

First Posted

March 22, 2019

Study Start

November 1, 2018

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 18, 2025

Record last verified: 2025-03

Locations