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Perthes Disease in Norway

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ClinicalTrials.gov Identifier: NCT03885960
Recruitment Status : Enrolling by invitation
First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
Sophies Minde Foundation
Information provided by (Responsible Party):
Stefan Huhnstock, Oslo University Hospital

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.

Condition or disease
Legg Calve Perthes Disease

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Study Type : Observational
Estimated Enrollment : 425 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Nationwide Study of Perthes` Disease in Norway: Functional and Radiographic Outcomes at a Mean Follow-up of Twenty Years
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025





Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885960


Locations
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Norway
Oslo University Hospital - Rikshospitalet
Oslo, Sognsvannsveien 20, Norway, 0372
Sponsors and Collaborators
Oslo University Hospital
Sophies Minde Foundation
Investigators
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Principal Investigator: Stefan Huhnstock, Phd Oslo University Hospital
  Study Documents (Full-Text)

Documents provided by Stefan Huhnstock, Oslo University Hospital:
Study Protocol  [PDF] November 1, 2018
Informed Consent Form  [PDF] November 1, 2018


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Responsible Party: Stefan Huhnstock, Principal investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03885960     History of Changes
Other Study ID Numbers: 2018/1924
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stefan Huhnstock, Oslo University Hospital:
Hip
function
quality of life
osteoarthritis
Perthes
LCPD

Additional relevant MeSH terms:
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Legg-Calve-Perthes Disease
Femur Head Necrosis
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases