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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 201

Contacts and Locations

• Study Contact: Name: Nicole Simunovic, MSc; Phone Number: (289) 237-3224; Email: simunon@mcmaster.ca
• Study Contact Backup: Name: Andrew Duong, MSc; Phone Number: 9059232126; Email: duonga@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N3Z5
      • McMaster University
  • Quebec
    • Québec, Quebec, Canada, G1J1Z4
      • Chu du Quebec
• Korea, Republic of
  • North Gyeongsang
    • Daegu, North Gyeongsang, Korea, Republic of, 41944
      • Kyungpook National University Hospital
• Netherlands
  • Rotterdam, Netherlands
    • Erasmus Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 14 years (Child)
• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Sport specialists, MVPA; AOSSM Criteria: Participation in intensive training and/or competition in organized sports greater than 8 months per year (essentially year round); Participation in 1 sport to the exclusion of participation in other sports (limited free play overall); 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: Participation in more than 1 sport at any physical activity level OR; Participation in none or low training and/or competition in organized sports for any period of time.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of radiographic FAI	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip function	As determined by the Hip Outcome Score	2 years
Health-related quality of life	As determined by the Pediatric Quality of Life questionnaire	2 years

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Canadian Institutes of Health Research (CIHR); McMaster Surgical Association; Arthroscopy Association of North America; Conmed

Publications and helpful links

General Publications

• Ohlin A, Simunovic N, Duong A, Ayeni OR; PREVIEW investigators. Protocol for a multicenter prospective cohort study evaluating sport activity and development of femoroacetabular impingement in the adolescent hip. BMC Musculoskelet Disord. 2020 Apr 11;21(1):221. doi: 10.1186/s12891-020-03220-6.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2017
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (Actual): March 27, 2019

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Femoracetabular Impingement
• Other Study ID Numbers: PREVIEW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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