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Prospective Evaluation of Sport Activity and the Development of Femoroacetabular Impingement in the Adolescent Hip (PREVIEW)

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ClinicalTrials.gov Identifier: NCT03891563
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : August 25, 2020
Sponsor:
Collaborators:
McMaster Surgical Association
Arthroscopy Association of North America
Conmed
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University

Brief Summary:
Femoroacetabular impingement (FAI) is a condition of the hip where there is a mis-fit between the femoral head (ball) and hip acetabulum (socket). The abnormalities on the hip bones collide or "impinge" during movements such as hip flexion and rotation. Typically, patients with this condition are young adults who present with hip pain, loss of hip function, and in many cases, osteoarthritis later in life. The rate of diagnoses of FAI has dramatically risen across all age groups, but it has been especially notable within adolescent populations. There has been a corresponding increase in the number of surgeries performed on younger and younger hips to treat pain and loss of function due to this condition. Preliminary small-scale research has hypothesized that increased activity, such as sport specialization (i.e. playing only one sport for most of the year) at an early age when the hip is still developing, may be the cause. In the past 20 years, sport injuries among children have dramatically increased, where close to 45 million young athletes participate in organized sports annually in Canada and the US alone. There is a current trend among coaches and parents to have children focus on one sport with the thought that this dedication will allow them to reach an elite level. We are proposing the first international, longitudinal cohort study to determine the effect of sport specialization on the development of FAI during the critical phase of hip development (i.e. between the ages of 12-14 years). Volunteer participants will be recruited across Canada and internationally and will be evaluated clinically and radiographically (i.e. using MRI) over 2 years. This study will not only prospectively evaluate the role of sport activity the development of FAI, but also inform preventative training protocols to potentially reduce its incidence among adolescents, and later as adults, as well as identify parameters to detect hips that are at risk for developing FAI.

Condition or disease
Femoroacetabular Impingement

Detailed Description:
This is a multi-centre, international longitudinal cohort study evaluating 200 participants between the ages of 12-14 that include sport specialists at the moderate to vigorous physical activity (MVPA) level and non-sport specialists at any activity level. Participant groups will be defined according to the AOSSM and AMSSM early sport specialization criteria (2016). We will monitor physical activity levels of all participants using an activity log and a wrist-mounted activity tracker, with synced data collected every 3 months during the study period. In addition, participants will be evaluated clinically and radiographically at time of enrollment and 6, 12, 18, and 24 months. The primary study outcome is the incidence of FAI between groups at 2 years, determined via MRI. Secondary outcomes include hip function and health-related quality of life between subjects diagnosed with FAI versus no FAI at 2 years, as determined by the HOS and PedsQL questionnaires.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Sport Activity and the Development of Femoroacetabular Impingement in the Adolescent Hip (PREVIEW)
Actual Study Start Date : October 18, 2017
Estimated Primary Completion Date : January 10, 2023
Estimated Study Completion Date : January 10, 2024

Group/Cohort
Sport specialists, MVPA

AOSSM Criteria:

  1. Participation in intensive training and/or competition in organized sports greater than 8 months per year (essentially year round)
  2. Participation in 1 sport to the exclusion of participation in other sports (limited free play overall)
  3. Involving prepubertal (seventh grade or roughly age 12 years) children.

AND

Activity Tracker Criteria:

Greater than 180 accumulated minutes of moderate-to-vigorous physical activity (MVPA) during participation in one sport type across one week of activity tracking

- Meets these criteria within either one or both years of follow-up

Non-sport specialist, any activity level

AOSSM Criteria:

  1. Participation in more than 1 sport at any physical activity level OR
  2. Participation in none or low training and/or competition in organized sports for any period of time.
  3. Involving prepubertal children.

AND

Activity Tracker Criteria:

Greater than or less than 180 accumulated minutes of MVPA across one week of activity tracking

- Meets these criteria during both years of follow-up




Primary Outcome Measures :
  1. Incidence of radiographic FAI [ Time Frame: 2 years ]
    The primary outcome is the incidence of radiographic FAI between groups at 2 years, as determined by the dedicated MRI of the hip. We will identify both symptomatic and asymptomatic cases, where asymptomatic FAI can become symptomatic in young adulthood, and/or could be associated with idiopathic osteoarthritis later in life.


Secondary Outcome Measures :
  1. Hip function [ Time Frame: 2 years ]
    As determined by the Hip Outcome Score

  2. Health-related quality of life [ Time Frame: 2 years ]
    As determined by the Pediatric Quality of Life questionnaire



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Ages Eligible for Study:   12 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will be comprised of adolescents aged 12-14 with no prior or ongoing hip comorbidities, and consent to receiving MRI scans at baseline and 2 years.
Criteria

Inclusion Criteria:

  1. asymptomatic males and females between the ages of 12-14 years
  2. ability to speak, understand, and read the language of the clinical site
  3. provision of informed child assent (if applicable) and parental consent.

Exclusion Criteria:

  1. hip is mature (i.e. closed physes) based on the baseline MRI scan
  2. hip complaints or pain in the hip
  3. previous trauma to the hip
  4. previous surgery on the hip
  5. significant medical co-morbidities (requiring daily assistance for ADLs)
  6. history of or ongoing paediatric hip disease (Legg-Calve-Perthes; slipped capital femoral epiphysis, hip dysplasia)
  7. participants that have contraindications and/or are unwilling to undergo an MRI (e.g. claustrophobia)
  8. participants who will likely have problems, in the judgment of the investigator, with maintaining follow-up
  9. any other reasons the investigator feels is relevant for excluding the subject.

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): NCT03891563


Contacts
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Contact: Nicole Simunovic, MSc ‭(289) 237-3224 simunon@mcmaster.ca
Contact: Andrew Duong, MSc 9059232126 duonga@mcmaster.ca

Locations
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Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada, L8N3Z5
Contact: Olufemi R Ayeni, MD, PhD    9059232126    duonga@mcmaster.ca   
Contact: Nicole Simunovic, MSc    9059232126    simunon@mcmaster.ca   
Canada, Quebec
Chu du Quebec Active, not recruiting
Québec, Quebec, Canada, G1J1Z4
Korea, Republic of
Kyungpook National University Hospital Active, not recruiting
Daegu, North Gyeongsang, Korea, Republic of, 41944
Netherlands
Erasmus Medical Centre Active, not recruiting
Rotterdam, Netherlands
Sponsors and Collaborators
McMaster University
McMaster Surgical Association
Arthroscopy Association of North America
Conmed
Canadian Institutes of Health Research (CIHR)
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03891563    
Other Study ID Numbers: PREVIEW
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Femoracetabular Impingement
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes