Femoroacetabular ImpingementNCT01799200
Hip Pathomorphology in Collegiate Athletes and Controls
An observational study of Femoroacetabular Impingement and Dysplasia, run by University of Utah.
Trial summary
The primary objective of this study is to investigate factors hypothesized to influence the prevalence of hip pathomorphology (femoroacetabular impingement, dysplasia) in young adults. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Femoroacetabular Impingement, Dysplasia
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Feb 2015
- Phase
- Observational
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Study population: Male and Female 18-30 years old and athletes. Age matched controls.
Who may be able to join
- Athletes:
- Males and females aged 18-30 years
- All athletes participating in Division 1A collegiate sports or club sports at the University of Utah
- All students in the Ballet and Modern Dance departments at the University of Utah
- All individuals on cheerleading teams
- Control Subjects:
- Volunteers in the same age range as the athletic subjects (18-30 years)
- Students attending the University of Utah at all academic departments except Ballet, Modern Dance and Exercise and Sport Science.
Who cannot join
- Minors (under age 18)
- mentally disabled
- persons incarcerated
- on parole, probation awaiting trial
- pregnant women
- A positive human Chorionic Gonadotropin (hCG) urine pregnancy test
Show all 12Show fewer
- Athletes:
- Players from the University of Utah football team
- Control Subjects:
- Any individual who participated in varsity sports during high school
- Currently participating in collegiate or club sports
- Students in the Ballet, Modern Dance and Exercise and Sport Science departments, or on the cheerleading team
About this study
Official title: Prevalence of Hip Pathomorphology in Collegiate Athletes and Age-Matched Controls: Radiographic and Physical Exam Findings
The primary objective of this study is to investigate factors hypothesized to influence the prevalence of hip pathomorphology (femoroacetabular impingement, dysplasia) in young adults. To complete this objective, we will quantify the prevalence of radiographic measures indicative of hip pathomorphology in collegiate athletes and age-matched controls. This data will allow us to test our main hypothesis, that the prevalence of hip pathomorphology is higher in collegiate athletes than age-matched controls. To further elucidate the factors which may increase the prevalence of hip pathomorphology, we will correlate the radiographic measures to sport involvement history, hip function and demographics, as collected by means of a questionnaire.
The secondary objective of this study is to determine if physical exams (range of motion, impingement test) could be used to screen for radiographic measures of hip pathomorphology in athletes and age-matched controls. To complete this objective, we will correlate range physical exam results to the radiographic measures and determine each exam's sensitivity and specificity to detect abnormal morphology.
Read the detailed description
Overview of Hip Pathomorphology. Osteoarthritis (OA) of the hip is the loss of articular cartilage in the load bearing areas of the joint. OA affects one in six adults, with hip OA affecting 9 million US citizens. Abnormal bony morphology of the femur and/or acetabulum (herein called pathomorphology) is believed to initiate damage to the articular cartilage and acetabular labrum and may predispose the hip to early OA. This study focuses on two types of hip pathomorphology: femoroacetabular impingement (FAI) and acetabular dysplasia. FAI is characterized by reduced clearance between the femoral head and acetabulum due to femoral head/neck asphericity (cam FAI), acetabular overcoverage (pincer FAI), or a combination of the two (mixed FAI). Dysplasia is characterized by a shallow or maloriented acetabulum.
Elevated Risk of Hip Pathomorphology in Athletes. Hip pathomorphology is a common cause of hip pain in athletes, and can limit or end sports participation. Collegiate and professional athletes are considered at high risk for symptomatic FAI and dysplasia due to demands placed on their hips during repetitive sport-specific motions. Sports which require supra-physiologic hip motion may cause underlying bony abnormalities to become symptomatic by initiating and/or aggravating chondrolabral damage. For example, hockey requires repetitive hip flexion with internal rotation that is hypothesized to lead to increased incidence and pain related to FAI.
Athletes are also considered at high risk for the development of symptomatic FAI because they are hypothesized to have a higher prevalence of underlying bony abnormalities. Radiographic findings consistent with hip pathomorphology are present not only in symptomatic patients but also in asymptomatic individuals. In general population, previous estimates of prevalence are 15-30% for FAI and 6-7% for dysplasia. It is hypothesized that the prevalence of FAI in some athletes may be much higher, but the prevalence of dysplasia is equivalent. High physical demand during the critical stages of hip development or beyond may initiate remodeling, leading to abnormalities consistent with FAI. This remodeling is not hypothesized to occur with dysplasia, but has not been investigated.
Diagnosis and Treatment of Hip Pathomorphology. Arthroscopic and open surgical treatment of symptomatic FAI and dysplasia seeks to reduce pain, improve function and prevent/delay osteoarthritis by restoring normal joint morphology. If surgery is performed before radiographic evidence of osteoarthritis exists, most professional athletes can return to their pre-surgery level of play. For example, 28 hockey players who underwent arthroscopic treatment of FAI return to sports at a mean of 3.8 months. Interestingly, those who had already developed arthritis or experienced a delay in treatment from the onset of hip pain had a delayed return to sport. Thus, early diagnosis and prompt treatment may be important to optimize clinical outcomes and facilitate the return to sport for athletic patients.
While the timeliness of a proper diagnosis continues to improve, misdiagnosis can occur by clinicians not familiar with hip pathomorphology. For example, prior to being diagnosed with FAI, many patients consult multiple health-care providers and even undergo unnecessary surgical procedures. Even professional athletes are not treated immediately, with the average time from onset of symptoms to treatment reported to be 29.6 months.
Motivation. While no study has supported prophylactic treatment of abnormal bony morphology in asymptomatic hips, symptomatic hips could benefit from early treatment to prevent further chondrolabral damage. The overall goal of this study is to improve the diagnosis and timeliness of treatment of hip pathomorphology by 1) identifying "at-risk" populations and 2) determining if physical exams could be used to screen members of "at-risk" populations for underlying abnormalities.
- Conditions
- Femoroacetabular Impingement, Dysplasia
- Keywords
- Collegiate Athletes, Hip Pathomorphology, Age-Matched Controls, Femoroacetabular Impingement, Dysplasia
- Medical subject headings
- Femoracetabular Impingement
What is being measured
The primary outcome is the main question the study is designed to answer.
X-ray Measurements of Femoroacetabular Impingement
Provides a method to quantify the type and extent of hip pathomorphology and is central to the diagnosis of patients presenting to the clinic with hip pain.
Measured: 5 years
Secondary outcomes (1)
Asymptomatic Femoroacetabular Impingement Abnormalities
Clinical Exams may provide a non-invasive tool to diagnosis FAI and Dysplasia.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startJun 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Pelt, University of Utah
- Investigators
- Chris Pelt, Principal investigator, Orthopedic Surgery Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799200
- Sponsor's protocol ID
- 55028
- Status last verified
- Aug 2015
- First submitted
- 5 Feb 2013
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kapron AL, Peters CL, Aoki SK, Beckmann JT, Erickson JA, Anderson MB, Pelt CE. The prevalence of radiographic findings of structural hip deformities in female collegiate athletes. Am J Sports Med. 2015 Jun;43(6):1324-30. doi: 10.1177/0363546515576908. Epub 2015 Mar 31.
PubMed 25828079
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hip Pathomorphology in Collegiate Athletes and Age-Matched Controls: Radiographic and Physical Exam Findings
- ClinicalTrials.gov ID
- NCT01799200
- Acronym / sponsor ID
- 55028
- Conditions
- Femoroacetabular Impingement, Dysplasia
- Keywords
- Collegiate Athletes, Hip Pathomorphology, Age-Matched Controls, Femoroacetabular Impingement, Dysplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 26 Feb 2013 (estimated)
- 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.
The primary objective of this study is to investigate factors hypothesized to influence the prevalence of hip pathomorphology (femoroacetabular impingement, dysplasia) in young adults. To complete this objective, we will quantify the prevalence of radiographic measures indicative of hip pathomorphology in collegiate athletes and age-matched controls. This data will allow us to test our main hypothesis, that the prevalence of hip pathomorphology is higher in collegiate athletes than age-matched controls. To further elucidate the factors which may increase the prevalence of hip pathomorphology, we will correlate the radiographic measures to sport involvement history, hip function and demographics, as collected by means of a questionnaire.
The secondary objective of this study is to determine if physical exams (range of motion, impingement test) could be used to screen for radiographic measures of hip pathomorphology in athletes and age-matched controls. To complete this objective, we will correlate range physical exam results to the radiographic measures and determine each exam's sensitivity and specificity to detect abnormal morphology.
Detailed description
Overview of Hip Pathomorphology. Osteoarthritis (OA) of the hip is the loss of articular cartilage in the load bearing areas of the joint. OA affects one in six adults, with hip OA affecting 9 million US citizens. Abnormal bony morphology of the femur and/or acetabulum (herein called pathomorphology) is believed to initiate damage to the articular cartilage and acetabular labrum and may predispose the hip to early OA. This study focuses on two types of hip pathomorphology: femoroacetabular impingement (FAI) and acetabular dysplasia. FAI is characterized by reduced clearance between the femoral head and acetabulum due to femoral head/neck asphericity (cam FAI), acetabular overcoverage (pincer FAI), or a combination of the two (mixed FAI). Dysplasia is characterized by a shallow or maloriented acetabulum.
Elevated Risk of Hip Pathomorphology in Athletes. Hip pathomorphology is a common cause of hip pain in athletes, and can limit or end sports participation. Collegiate and professional athletes are considered at high risk for symptomatic FAI and dysplasia due to demands placed on their hips during repetitive sport-specific motions. Sports which require supra-physiologic hip motion may cause underlying bony abnormalities to become symptomatic by initiating and/or aggravating chondrolabral damage. For example, hockey requires repetitive hip flexion with internal rotation that is hypothesized to lead to increased incidence and pain related to FAI.
Athletes are also considered at high risk for the development of symptomatic FAI because they are hypothesized to have a higher prevalence of underlying bony abnormalities. Radiographic findings consistent with hip pathomorphology are present not only in symptomatic patients but also in asymptomatic individuals. In general population, previous estimates of prevalence are 15-30% for FAI and 6-7% for dysplasia. It is hypothesized that the prevalence of FAI in some athletes may be much higher, but the prevalence of dysplasia is equivalent. High physical demand during the critical stages of hip development or beyond may initiate remodeling, leading to abnormalities consistent with FAI. This remodeling is not hypothesized to occur with dysplasia, but has not been investigated.
Diagnosis and Treatment of Hip Pathomorphology. Arthroscopic and open surgical treatment of symptomatic FAI and dysplasia seeks to reduce pain, improve function and prevent/delay osteoarthritis by restoring normal joint morphology. If surgery is performed before radiographic evidence of osteoarthritis exists, most professional athletes can return to their pre-surgery level of play. For example, 28 hockey players who underwent arthroscopic treatment of FAI return to sports at a mean of 3.8 months. Interestingly, those who had already developed arthritis or experienced a delay in treatment from the onset of hip pain had a delayed return to sport. Thus, early diagnosis and prompt treatment may be important to optimize clinical outcomes and facilitate the return to sport for athletic patients.
While the timeliness of a proper diagnosis continues to improve, misdiagnosis can occur by clinicians not familiar with hip pathomorphology. For example, prior to being diagnosed with FAI, many patients consult multiple health-care providers and even undergo unnecessary surgical procedures. Even professional athletes are not treated immediately, with the average time from onset of symptoms to treatment reported to be 29.6 months.
Motivation. While no study has supported prophylactic treatment of abnormal bony morphology in asymptomatic hips, symptomatic hips could benefit from early treatment to prevent further chondrolabral damage. The overall goal of this study is to improve the diagnosis and timeliness of treatment of hip pathomorphology by 1) identifying "at-risk" populations and 2) determining if physical exams could be used to screen members of "at-risk" populations for underlying abnormalities.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Male and Female 18-30 years old and athletes. Age matched controls.
Key inclusion criteria (8 listed)
- Males and females aged 18-30 years
- All athletes participating in Division 1A collegiate sports or club sports at the University of Utah
- All students in the Ballet and Modern Dance departments at the University of Utah
- All individuals on cheerleading teams
- Volunteers in the same age range as the athletic subjects (18-30 years)
Key exclusion criteria (12 listed)
- Minors (under age 18)
- mentally disabled
- persons incarcerated
- on parole, probation awaiting trial
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
X-ray Measurements of Femoroacetabular Impingement
Time frame: 5 years
Provides a method to quantify the type and extent of hip pathomorphology and is central to the diagnosis of patients presenting to the clinic with hip pain.
1 secondary outcome
Asymptomatic Femoroacetabular Impingement Abnormalities
Time frame: 5 years
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 13 Aug 2015.
- Results publication: PubMed 25828079Kapron AL, Peters CL, Aoki SK, Beckmann JT, Erickson JA, Anderson MB, Pelt CE. The prevalence of radiographic findings of structural hip deformities in female collegiate athletes. Am J Sports Med. 2015 Jun;43(6):1324-30. doi: 10.1177/0363546515576908. Epub 2015 Mar 31.
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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.
Chris Pelt principal investigator
Orthopedic Surgery Operations
Questions about this trial
What is this clinical trial studying?
An observational study of Femoroacetabular Impingement and Dysplasia, run by University of Utah.
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 8 inclusion and 12 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 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
X-ray Measurements of Femoroacetabular Impingement (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01799200, which also lists 1 linked publication.
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 13 Aug 2015.