NCT03891563

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.

Trial Health

58
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
3 countries

4 active sites

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2024

Enrollment Period

7.8 years

First QC Date

March 25, 2019

Last Update Submit

November 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Hip function

    2 years

  • Health-related quality of life

    2 years

Study Arms (2)

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

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

McMaster University

Hamilton, Ontario, L8N3Z5, Canada

Location

Chu du Quebec

Québec, Quebec, G1J1Z4, Canada

Location

Erasmus Medical Centre

Rotterdam, Netherlands

Location

Kyungpook National University Hospital

Daegu, Gyeongsangbuk-do, 41944, South Korea

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2019

First Posted

March 27, 2019

Study Start

October 18, 2017

Primary Completion

July 31, 2025

Study Completion

December 31, 2025

Last Updated

November 21, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations