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Trial record 5 of 10 for:    "Legg-Calve-Perthes disease"

WOMAC Hip Score in Children and Adolescents With Perthes Disease (WOMAC)

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ClinicalTrials.gov Identifier: NCT02795494
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
Kishore Mulpuri, British Columbia Children's Hospital

Brief Summary:

Patient oriented clinical outcomes have increased in use and popularity and provide a comprehensive assessment of the level of symptoms and function experienced by a patient. Though several measures have been developed and shown to be valid, reliable, and responsive in adults, such efforts have only been rarely undertaken in pediatric populations. Specifically, there has been no validation of the predominant adult hip specific outcome measures, such as the WOMAC and Oxford-12, in children and adolescents. Prior to using such measures in pediatric patients, it is necessary to establish the psychometric properties of these measurements in this population.

The objective of this study is to determine the reliability and validity of the WOMAC hip scores in a pediatric population, between five and nineteen years of age, with Perthes disease. The results of this study will accomplish the above goal, thereby allowing either for widespread use of these measures in pediatric hip disorders or emphasizing the necessity for development of a pediatric hip specific outcome measure.


Condition or disease Intervention/treatment
Legg-Calvé-Perthes Disease Behavioral: WOMAC questionnaire at baseline Behavioral: ASK-P questionnaire at baseline Behavioral: WOMAC questionnaire at 2 weeks

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation and Reliability Testing of the Western Ontario and McMaster Osteoarthritis Scale (WOMAC) Hip Score in Children and Adolescents With Perthes Disease
Study Start Date : May 2007
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020


Group/Cohort Intervention/treatment
Perthes Group
Participants with Perthes disease. Will be given WOMAC questionnaire at baseline and WOMAC questionnaire at 2 weeks, and ASK-P questionnaire at baseline.
Behavioral: WOMAC questionnaire at baseline
Patient-reported pain, stiffness and physical function outcome score

Behavioral: ASK-P questionnaire at baseline
Patient-reported activity level score

Behavioral: WOMAC questionnaire at 2 weeks
Patient-reported pain, stiffness and physical function outcome score

Fracture Control Group
Participants with an upper extremity fracture but no hip-related conditions. Will be given WOMAC questionnaire at baseline.
Behavioral: WOMAC questionnaire at baseline
Patient-reported pain, stiffness and physical function outcome score




Primary Outcome Measures :
  1. Difference in WOMAC questionnaire scores between the five Stulberg classification stages in the Perthes group [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Difference in WOMAC questionnaire scores between baseline and 2 weeks [ Time Frame: Baseline to two weeks ]
  2. Difference in WOMAC questionnaire scores between the Perthes and control group [ Time Frame: Baseline ]
  3. Correlation between WOMAC questionnaire and ASK-P scores in the Perthes group [ Time Frame: Baseline ]


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Ages Eligible for Study:   5 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All children and adolescents, between the ages of five and nineteen years, being followed at the Orthopaedic clinic of a participating center with a diagnosis of an upper extremity fracture or healed Perthes disease will be eligible for inclusion in the study.
Criteria

Inclusion Criteria:

  • All participants will be between 5-19 years
  • Healed Perthes disease. Healed Perthes disease will be defined radiographically, in the accepted fashion, by the appearance of normal bone density of the femoral head. The restriction of those with Perthes disease to only those with resolution of the disease will prevent heterogeneity of the clinical presentation and anticipated functional abilities which would occur by including those in the acute phases of the disease, thereby reducing potential bias.
  • All participants will have to be able to complete the questionnaires in English and, for those with Perthes disease, be able to complete the questionnaires again two weeks following the initial completion.

Exclusion Criteria:

  • Amongst those being followed at the orthopaedic clinic of a participating center with an upper extremity fracture, those with a history of a hip disorder will be excluded. The reason for this is that these subjects will compose a comparison group with normal hip function, consequently a history of hip disorder would bias this comparison.
  • Those with Perthes disease who demonstrate acute phases of the disease will be excluded. Acute phases of the disease will be defined in the accepted fashion, by the radiographic presence of fragmentation or reossification of the femoral head.
  • Those who do not provide consent for participation in the study will be excluded, as will those who either cannot complete the questionnaire in English or are unable to complete a second set of questionnaires at two weeks.
  • Those with cognitive impairment, precluding completion of the questionnaires, will be excluded.
  • All those with concomitant medical problems will be excluded due to possible confounding of the clinical outcome measures.

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): NCT02795494


Contacts
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Contact: Kishore Mulpuri, MBBS, MS(Ortho), MHSc 604-875-2054 kmulpuri@cw.bc.ca
Contact: Emily Schaeffer, PhD 604-875-2359 emily.schaeffer@cw.bc.ca

Locations
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Canada, British Columbia
British Columbia Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Kishore Mulpuri, MBBS, MS(Ortho), MHSc    604-875-2054    kmulpuri@cw.bc.ca   
Sponsors and Collaborators
British Columbia Children's Hospital
Investigators
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Principal Investigator: Kishore Mulpuri, MBBS, MS(Ortho), MHSc Provincial Health Services Authority

Publications:
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Responsible Party: Kishore Mulpuri, Pediatric Orthopaedic Surgeon, British Columbia Children's Hospital
ClinicalTrials.gov Identifier: NCT02795494     History of Changes
Other Study ID Numbers: H0700752
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Legg-Calve-Perthes Disease
Femur Head Necrosis
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases