Femoroacetabular ImpingementCAM-FAI reliaNCT04822571
Investigating the Reliability of Highly Dynamic 3D Motion Analysis Protocol in Adolescence and Adult Males
A study testing Reliability of 3D motion analysis protocol in people with Femoroacetabular Impingement, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- Reliability of 3D motion analysis protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Mar 2021to 11 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 35 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Group 1: adolescent males aged 12-16 years old
- Group 2: adult males aged 25-35 years old
Who cannot join
- Volunteers who received major prior surgery of the lower limbs or with any pathology, injury or disorder known to affect the locomotor system
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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. FAI can be radiologically classified into 3 types of morphology: Pincer, CAM and mixed type. Pincer morphology is mainly characterized on radiological films by an over-coverage of the acetabulum, has a high center edge angle and is seen in females more frequently. CAM morphology is characterized by an increase in bone formation at the femoral head-neck junction and is mainly identified by a large alpha angle on medical imaging scans. Unlike pincer, CAM morphology occurs mainly in males. Mixed morphology is a third type of FAI and consists of a combination of both CAM and pincer impingement characteristics. FAI has been increasingly garnering attention in the last two decades due to two main reasons.
The first reason is its recognition as a leading cause of hip pain in the young economically-active adult. Epidemiological reports show the average age of FAI patients is 28 years old. Furthermore, a significant number of FAI patients are athletes who have professional careers that heavily depend on their physical wellbeing. The second reason FAI has been in the spotlight of orthopedic research recently, is the growing evidence linking it to early cartilage and labral damage, and subsequently to the development of hip osteoarthritis (OA). Ganz and colleagues were the first to make this link and assumed that the presence of the inter-articular morphological abnormality leads to abutment of the femoral head-neck junction against the acetabular rim. This repeated mechanical abutment is assumed to then lead to acetabular labral damage and progressive breakdown of the chondrolabral junction, thereby leading to chondral defects and the eventual onset of OA. Hip OA by itself is an acknowledged source of pain/disability and is associated with an ever-increasing socioeconomic cost.
A recent systematic review on the prevalence of symptomatic hip morphology reported the prevalence of CAM type deformity to be 37%; the prevalence of pincer deformity was 67% in the general population. Interestingly, there was an almost 3:1 ratio of CAM deformity in an athletic population compared with non-athletes. This was not the case for pincer deformity. Furthermore, such morphological findings are increasingly being reported in the adolescent athletic population specifically. A number of recent studies found a markedly higher prevalence of cam deformities in asymptomatic adolescents participating in, specifically, soccer, ice-hockey and basketball as compared with their non-athlete controls. Such reports have led researchers to speculate whether participating in high intensity physical activity at the critical period of bone maturation prior to femoral physis closure (10 - 15 years of age) could cause CAM deformity post femoral physis closure (15 -18 years of age old). It is hypothesized that a CAM in this population could form either due to new bone formation at the anterosuperior head-neck junction, or be induced by changes in the shape of the growth plate due to high shear forces acting on the growing hip during these athletic activities. However, as of date there is no concrete evidence to support this hypothesis. Consequently, the reasons behind the formations of CAM deformity in adolescent athletes remain unclear and call for further research. Such research is imperative to increase our understanding of the effect high training load can have on the wellbeing and long term health of young athletes.
It is with this background in mind that 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.
- Conditions
- Femoroacetabular Impingement
- Being tested
- Reliability of 3D motion analysis protocol
- Keywords
- 3D motion analysis, Reliability
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reliability of 3D motion analysis protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Adolescent volunteers | Other | Adolescent males aged 12-16 years old Receives: Other: Reliability of 3D motion analysis protocol |
| Adult volunteers | Other | Adult males aged 25-35 years old Receives: Other: Reliability of 3D motion analysis protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematic parameters in order for reliability
The construction of all kinematic measurements in order for reliability using 3D motion analysis
Measured: within a time interval of 1 month
Secondary outcomes (2)
Copenhagen Hip and Groin Outcome Score (HAGOS)
The assessment of symptoms, activity limitations, participation restrictions and QOL in physically active, young to middle-aged patients with long-standing hip and/or groin pain
Measured: within a time interval of 1 month
International Hip Outcome Tool (IHOT)
To obtain subjective measures of symptoms, as well as determining emotional and social health status
Measured: within a time interval of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start23 Mar 2021
- Primary completion11 Oct 2024
- Study completion11 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stijn Ghijselings, M.D., Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822571
- Sponsor's protocol ID
- S64417
- Acronym
- CAM-FAI relia
- Status last verified
- Apr 2025
- First submitted
- 16 Mar 2021
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Reliability of Highly Dynamic 3D Motion Analysis Protocol in Adolescence and Adult Males
- ClinicalTrials.gov ID
- NCT04822571
- Acronym / sponsor ID
- CAM-FAI relia / S64417
- Conditions
- Femoroacetabular Impingement
- Keywords
- 3D motion analysis, Reliability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 11 Oct 2024 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. FAI can be radiologically classified into 3 types of morphology: Pincer, CAM and mixed type. Pincer morphology is mainly characterized on radiological films by an over-coverage of the acetabulum, has a high center edge angle and is seen in females more frequently. CAM morphology is characterized by an increase in bone formation at the femoral head-neck junction and is mainly identified by a large alpha angle on medical imaging scans. Unlike pincer, CAM morphology occurs mainly in males. Mixed morphology is a third type of FAI and consists of a combination of both CAM and pincer impingement characteristics. FAI has been increasingly garnering attention in the last two decades due to two main reasons.
The first reason is its recognition as a leading cause of hip pain in the young economically-active adult. Epidemiological reports show the average age of FAI patients is 28 years old. Furthermore, a significant number of FAI patients are athletes who have professional careers that heavily depend on their physical wellbeing. The second reason FAI has been in the spotlight of orthopedic research recently, is the growing evidence linking it to early cartilage and labral damage, and subsequently to the development of hip osteoarthritis (OA). Ganz and colleagues were the first to make this link and assumed that the presence of the inter-articular morphological abnormality leads to abutment of the femoral head-neck junction against the acetabular rim. This repeated mechanical abutment is assumed to then lead to acetabular labral damage and progressive breakdown of the chondrolabral junction, thereby leading to chondral defects and the eventual onset of OA. Hip OA by itself is an acknowledged source of pain/disability and is associated with an ever-increasing socioeconomic cost.
A recent systematic review on the prevalence of symptomatic hip morphology reported the prevalence of CAM type deformity to be 37%; the prevalence of pincer deformity was 67% in the general population. Interestingly, there was an almost 3:1 ratio of CAM deformity in an athletic population compared with non-athletes. This was not the case for pincer deformity. Furthermore, such morphological findings are increasingly being reported in the adolescent athletic population specifically. A number of recent studies found a markedly higher prevalence of cam deformities in asymptomatic adolescents participating in, specifically, soccer, ice-hockey and basketball as compared with their non-athlete controls. Such reports have led researchers to speculate whether participating in high intensity physical activity at the critical period of bone maturation prior to femoral physis closure (10 - 15 years of age) could cause CAM deformity post femoral physis closure (15 -18 years of age old). It is hypothesized that a CAM in this population could form either due to new bone formation at the anterosuperior head-neck junction, or be induced by changes in the shape of the growth plate due to high shear forces acting on the growing hip during these athletic activities. However, as of date there is no concrete evidence to support this hypothesis. Consequently, the reasons behind the formations of CAM deformity in adolescent athletes remain unclear and call for further research. Such research is imperative to increase our understanding of the effect high training load can have on the wellbeing and long term health of young athletes.
It is with this background in mind that 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescent volunteers | Other | Other: Reliability of 3D motion analysis protocolAdolescent males aged 12-16 years old |
| Adult volunteers | Other | Other: Reliability of 3D motion analysis protocolAdult males aged 25-35 years old |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Group 1: adolescent males aged 12-16 years old
- Group 2: adult males aged 25-35 years old
Key exclusion criteria (1 listed)
- Volunteers who received major prior surgery of the lower limbs or with any pathology, injury or disorder known to affect the locomotor system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reliability of 3D motion analysis protocolThe 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. | Other | Adolescent volunteers, Adult volunteers |
Primary outcome
Kinematic parameters in order for reliability
Time frame: within a time interval of 1 month
The construction of all kinematic measurements in order for reliability using 3D motion analysis
2 secondary outcomes
Copenhagen Hip and Groin Outcome Score (HAGOS)
Time frame: within a time interval of 1 month
International Hip Outcome Tool (IHOT)
Time frame: within a time interval of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stijn Ghijselings, M.D. principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reliability of 3D motion analysis protocol in people with Femoroacetabular Impingement, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinematic parameters in order for reliability (time frame: within a time interval of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.