NCT04822571

Brief Summary

Femoroacetabular impingement is an orthopedic condition that is primarily characterized by the presence of anatomic bony abnormalities in the femoral head and/or the acetabulum resulting in an abnormal contact between the two during hip motion, especially in positions of increased hip flexion and rotation, ultimately leading to hip pain. The main study was initiated with the goal of exploring the etiology of FAI in a multidimensional and novel way that addresses the major gaps in literature. Within the main study a 3D motion capture protocol has been designed in line with the latest literature recommendations, which called for more hip ROM specific movements and athlete oriented 3D motion capture protocols that incorporate the spinopelvic complex. While the protocol surely contains movements that have been previously validated and published such as squats and lunges, a unique addition of high velocity soccer kicks and hop- lunges have been included. Such additions elevate the relevancy of the 3D motion analysis protocol, however they also pose questions on how reliable and accurate these additions are. This is especially important a 3D motion analysis has a very subjective component, which is the placement of the skin markers by the clinician. Errors or alteration to markers placement between different sessions or different subjects have been shown to significantly affect the quality of data. Furthermore, not all physical movement can be properly documented using motion analysis. The velocity at which the movement is preformed combined with how complex it is can affect the quality of data collected by the motion analysis system. Also another important component is the uniqueness of the population recruited for the main study. Most studies with highly dynamic motion protocols have been validated and published on adult populations. Thus the investigators cannot use their findings liberally to compare with the adolescent protocol, as differences in patterns of motion between adults and adolescence have been documented. Indeed, a need to test the reliability of the investigators' protocol among their own study groups is highly imperative.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 16, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

March 23, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2024

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

3.6 years

First QC Date

March 16, 2021

Last Update Submit

April 10, 2025

Conditions

Keywords

3D motion analysisReliability

Outcome Measures

Primary Outcomes (1)

  • Kinematic parameters in order for reliability

    The construction of all kinematic measurements in order for reliability using 3D motion analysis

    within a time interval of 1 month

Secondary Outcomes (2)

  • Copenhagen Hip and Groin Outcome Score (HAGOS)

    within a time interval of 1 month

  • International Hip Outcome Tool (IHOT)

    within a time interval of 1 month

Study Arms (2)

Adolescent volunteers

OTHER

Adolescent males aged 12-16 years old

Other: Reliability of 3D motion analysis protocol

Adult volunteers

OTHER

Adult males aged 25-35 years old

Other: Reliability of 3D motion analysis protocol

Interventions

The intrinsic and extrinsic reliability of the designed 3D motion analysis protocol is measured in cases of high velocity dynamic movement such as kicking a soccer ball.

Adolescent volunteersAdult volunteers

Eligibility Criteria

Age12 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Group 1: adolescent males aged 12-16 years old
  • Group 2: adult males aged 25-35 years old

You may not qualify if:

  • \- Volunteers who received major prior surgery of the lower limbs or with any pathology, injury or disorder known to affect the locomotor system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stijn Ghijselings, M.D.

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 30, 2021

Study Start

March 23, 2021

Primary Completion

October 11, 2024

Study Completion

October 11, 2024

Last Updated

April 15, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations