Femoracetabular ImpingementDoD FAI-2NCT04243447
Identification of Predictors for Clinical Outcomes in Femoroacetabular Impingement Surgery
An observational study of Femoracetabular Impingement, run by Washington University School of Medicine at 13 sites in 2 countries.
Trial summary
The overarching goal of the study is to improve the surgical treatment outcomes of FAI, which is affecting an increasing number of military personnel and young active individuals in the general population. Read more about this study
- Who is it for?
- Ages 14 to 40 years
- Conditions the study is for
- Femoracetabular Impingement
- How many people
- 747 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 2 Feb 2020to 29 Nov 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 14 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Skeletally mature patients being treated surgically for FAI after failing conservative treatment.
Who may be able to join
- Age 14 - 40 years
- Skeletally Mature
- Failure of 6 weeks of conservative treatment
- Primary surgery (Hip Arthroscopic Treatment)
- Surgical treatment of FAI with hip arthroscopy
- Tonnis 0 -1 OA, with greater than 2 mm of joint space
- Clinical diagnosis of FAI (cam or combined; alpha >50 degrees)
Who cannot join
- Not a surgical candidate
- Skeletally Immature
- Acetabular Dysplasia (LCEA < 20)
- Tonnis 2+ OA
- Previous ipsilateral hip surgery
- Previous major hip trauma (hip fractures, hip dislocations)
Show all 11Show fewer
- Additional disease processes (e.g., Avascular Necrosis (AVN), synovial disease, Ehlers-Danlos Syndrome (EDS), neuromuscular disorders)
- Unable to consent due to mental faculty
- Pregnant women
- Non-English speaking patients
- Prisoners or other vulnerable populations
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States10 sites
University of Michigan
Ann Arbor, Michigan, 48106
University of Colorado
Aurora, Colorado, 80045
Boston Children's Hospital
Boston, Massachusetts, 02115
Scottish Rite Hospital for Children
Dallas, Texas, 75219
Twin Cities Orthopedics
Edina, Minnesota, 55435
University of Iowa
Iowa City, Iowa, 52242
University of Wisconsin, Madison
Madison, Wisconsin, 53706
Mayo Clinic
Rochester, Minnesota, 55902
San Antonio Military Medical Center
San Antonio, Texas, 78219
Washington University School of Medicine
St Louis, Missouri, 63110
Canada3 sites
Children's Hospital of Eastern Ontario
Ottawa, Ontario, (+4) K1H 8L1
The Ottawa Hospital
Ottawa, Ontario
CHU de Quebec - Universite Laval
Québec, Quebec
About this study
The overarching goal of the study is to improve the surgical treatment outcomes of FAI, which is affecting an increasing number of military personnel and young active individuals in the general population. The proposed study will investigate critical patient, disease, and surgical treatment predictors of FAI surgery outcomes.
Read the detailed description
PROCEDURES:
Potential participants will be identified at their initial PI's outpatient clinic at which the PI will meet with the patient and determine if the patient should be treated surgically due to a diagnosis of FAI. Once the PI identifies the patient as a surgical candidate, the research study team in the clinic will approach the patient with study information to discuss. If the patient would like to participate, the patient will sign an informed consent document (assent document for minors) and begin completing study-specific information. If the patient would like to take the study documents home to consider participation, the research team member will provide his/her contact information to the patient.
SPECIFIC AIMS:
- Determine the predictors of mid-term patient-reported outcomes (PROs) and treatment failures in an established prospective longitudinal cohort of Femoroacetabular Impingement (FAI) surgeries.
- Determine the impact of three-dimensional femoral and acetabular morphology on PROs at short-term follow-up in a novel prospective longitudinal cohort of arthroscopic FAI surgery.
- Determine if the new Patient-Reported Outcome Measurement Information System (PROMIS) correlates with legacy PROs in patients undergoing FAI surgery.
DATA COLLECTION:
- Retrospective Follow-up (FAI-1): The original cohort includes previously consented participants in a closed-to-enrollment study who underwent FAI surgical treatment in the past. This cohort will be followed to investigate the most important predictors of FAI surgery outcomes. In Specific Aim 1, we propose to analyze mid-term follow-up (minimum 8 years) of the FAI-1 cohort to identify important predictors of treatment outcomes and failures in FAI surgery.
- Prospective Enrollment (FAI-2): Consented participants, in the actively enrolling study, will be enrolled in a new multicenter longitudinal prospective arthroscopic FAI surgery cohort and followed to a minimum 2 years post-surgery (T2). The primary outcome measures will be the collection of the patient report outcomes (PROs) that will be analyzed in order to improve surgical care and outcomes. These clinical outcome metrics will be assessed at baseline, 3 months, 6 month, 1 year, and 2 year postoperatively.
- Conditions
- Femoracetabular Impingement
- Keywords
- Femoracetabular Impingement (FAI), Low-dose computed tomography (CT), Patient Reported Outcomes (PROs), Academic Network for Conservational Hip Outcomes Research (ANCHOR), Hip Arthroscopy, Osteoarthritis (OA)
- Medical subject headings
- Femoracetabular Impingement, Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip disability and Osteoarthritis Outcome Score (HOOS)
HOOS is a questionnaire constructed to assess patient-relevant outcomes in five separate sub-scales (pain, symptoms, activity of daily living, sport and recreation function and hip-related quality of life). HOOS is scored 0-100 with higher scores being the best outcome.
Measured: Pre operative (Baseline), change from baseline HOOS at 3 months, change from baseline HOOS at 6 months, change from baseline HOOS at 1 year, and change from baseline HOOS at 2 year.
Short Form Health Survey (SF-12)
The SF-12 is a shortened, validated, patient-reported survey of patient health with questions pulled directly from the longer form SF-36. SF-12 is scored 0-100 with higher scores being the best outcome.
Measured: Pre operative (Baseline), change from baseline SF-12 at 3 months, change from baseline SF-12 at 6 months, change from baseline SF-12 at 1 year, and change from baseline SF-12 at 2 year
Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference (PI)
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's pain interference. PROMIS - PI is scored from 38.7-83.8 with the lower scores being the best outcome.
Measured: Pre operative (Baseline), change from baseline PROMIS - PI at 3 months, change from baseline PROMIS - PI at 6 months, change from baseline PROMIS -PI at 1 year, and change from baseline PROMIS - PI at 2 year
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function (PF)
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's physical function. PROMIS - PF is scored from 14.7-75.6 with the higher scores being the best outcome.
Measured: Pre operative (Baseline), change from baseline PROMIS - PF at 3 months, change from baseline PROMIS - PF at 6 months, change from baseline PROMIS -PF at 1 year, and change from baseline PROMIS - PF at 2 year
Patient-Reported Outcomes Measurement Information System (PROMIS) - Mobility (M)
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's mobility. PROMIS - M is scored from 18.2-60.2 with the higher scores being the best outcome.
Measured: Pre operative (Baseline), change from baseline PROMIS - M at 3 months, change from baseline PROMIS - M at 6 months, change from baseline PROMIS -M at 1 year, and change from baseline PROMIS - M at 2 year
Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression (D)
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's depression. PROMIS - D is scored from 34.2-84.4 with the lower scores being the best outcome.
Measured: Pre operative (Baseline), change from baseline PROMIS - D at 3 months, change from baseline PROMIS - D at 6 months, change from baseline PROMIS - D at 1 year, and change from baseline PROMIS - D at 2 year
Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety (A)
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's anxiety. PROMIS - A is scored from 32.9-84.9 with the lower scores being the best outcome.
Measured: Pre operative (Baseline), change from baseline PROMIS - A at 3 months, change from baseline PROMIS - A at 6 months, change from baseline PROMIS - A at 1 year, and change from baseline PROMIS - A at 2 year
Secondary outcomes (5)
University of California Los Angeles Activity Score (UCLA Score)
UCLA Score represents a reliable tool for assessing the level of physical activity and the return to sport high functional demand after hip surgery. The UCLA Score is scored from 0-10 with higher scores being the best outcome.
Measured: Pre operative (Baseline), change from baseline UCLA Score at 3 months, change from baseline UCLA Score at 6 months, change from baseline UCLA Score at 1 year, and change from baseline UCLA Score at 2 year
International Hip Outcome Tool (iHot-12)
iHOT-12 is a validated 12-item short form of iHot-33. It was designed to measure the impact of hip disease in young, active patients and to measure the effect of treatment of this disease.
Measured: Pre operative (Baseline), change from baseline iHOT-12 at 3 months, change from baseline iHOT-12 at 6 months, change from baseline iHOT-12 at 1 year, and change from baseline iHOT-12 at 2 year
Modified Harris Hip Score (mHHS)
The mHHS is a reliable and valid tool for assessment of functional outcome, post total hip replacement in Indian patients, with a positive correlation with the standard Harris Hip Score. mHHS is scored 0-100 with higher scores being the best outcome.
Measured: Pre operative (Baseline), change from baseline mHHS at 3 months, change from baseline mHHS at 6 months, change from baseline mHHS at 1 year, and change from baseline mHHS at 2 year
Brief Resilience Scale (BRS)
The BRS was created to assess the ability to bounce back or recover from stress.
Measured: Pre operative (Baseline)
Mobility, Stability, and Pain (MSP Question)
Outcome measure to assess a patient's greatest issue with their hip. Asks a patient to rank mobility, stability, and pain from biggest problem to least problem.
Measured: Pre operative (Baseline), 3 months, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start2 Feb 2020
- Primary completion29 Nov 2025 (estimated)
- Study completion29 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoracetabular ImpingementStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 747 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- San Antonio Military Medical Center, Corewell Health East, Boston Children's Hospital, CHU de Quebec-Universite Laval, Mayo Clinic, Twin Cities Orthopedics, University of Michigan, Ottawa Hospital Research Institute, University of Texas Southwestern Medical Center, University of Iowa, University of Colorado, Denver, Children's Hospital of Eastern Ontario, University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- John C Clohisy, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243447
- Sponsor's protocol ID
- 201909174
- Acronym
- DoD FAI-2
- Status last verified
- Sep 2025
- First submitted
- 17 Jan 2020
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Predictors for Clinical Outcomes in Femoroacetabular Impingement Surgery
- ClinicalTrials.gov ID
- NCT04243447
- Acronym / sponsor ID
- DoD FAI-2 / 201909174
- Conditions
- Femoracetabular Impingement
- Keywords
- Femoracetabular Impingement (FAI), Low-dose computed tomography (CT), Patient Reported Outcomes (PROs), Academic Network for Conservational Hip Outcomes Research (ANCHOR), Hip Arthroscopy, Osteoarthritis (OA)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 747 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- San Antonio Military Medical Center, Corewell Health East, Boston Children's Hospital, CHU de Quebec-Universite Laval, Mayo Clinic, Twin Cities Orthopedics, University of Michigan, Ottawa Hospital Research Institute, University of Texas Southwestern Medical Center, University of Iowa, University of Colorado, Denver, Children's Hospital of Eastern Ontario, University of Wisconsin, Madison
- Study start
- 2 Feb 2020 (actual)
- Primary completion
- 29 Nov 2025 (estimated)
- Study completion
- 29 Nov 2025 (estimated)
- First posted
- 28 Jan 2020 (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.
The overarching goal of the study is to improve the surgical treatment outcomes of FAI, which is affecting an increasing number of military personnel and young active individuals in the general population. The proposed study will investigate critical patient, disease, and surgical treatment predictors of FAI surgery outcomes.
Detailed description
PROCEDURES:
Potential participants will be identified at their initial PI's outpatient clinic at which the PI will meet with the patient and determine if the patient should be treated surgically due to a diagnosis of FAI. Once the PI identifies the patient as a surgical candidate, the research study team in the clinic will approach the patient with study information to discuss. If the patient would like to participate, the patient will sign an informed consent document (assent document for minors) and begin completing study-specific information. If the patient would like to take the study documents home to consider participation, the research team member will provide his/her contact information to the patient.
SPECIFIC AIMS:
- Determine the predictors of mid-term patient-reported outcomes (PROs) and treatment failures in an established prospective longitudinal cohort of Femoroacetabular Impingement (FAI) surgeries.
- Determine the impact of three-dimensional femoral and acetabular morphology on PROs at short-term follow-up in a novel prospective longitudinal cohort of arthroscopic FAI surgery.
- Determine if the new Patient-Reported Outcome Measurement Information System (PROMIS) correlates with legacy PROs in patients undergoing FAI surgery.
DATA COLLECTION:
- Retrospective Follow-up (FAI-1): The original cohort includes previously consented participants in a closed-to-enrollment study who underwent FAI surgical treatment in the past. This cohort will be followed to investigate the most important predictors of FAI surgery outcomes. In Specific Aim 1, we propose to analyze mid-term follow-up (minimum 8 years) of the FAI-1 cohort to identify important predictors of treatment outcomes and failures in FAI surgery.
- Prospective Enrollment (FAI-2): Consented participants, in the actively enrolling study, will be enrolled in a new multicenter longitudinal prospective arthroscopic FAI surgery cohort and followed to a minimum 2 years post-surgery (T2). The primary outcome measures will be the collection of the patient report outcomes (PROs) that will be analyzed in order to improve surgical care and outcomes. These clinical outcome metrics will be assessed at baseline, 3 months, 6 month, 1 year, and 2 year postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Skeletally mature patients being treated surgically for FAI after failing conservative treatment.
Key inclusion criteria (7 listed)
- Age 14 - 40 years
- Skeletally Mature
- Failure of 6 weeks of conservative treatment
- Primary surgery (Hip Arthroscopic Treatment)
- Tonnis 0 -1 OA, with greater than 2 mm of joint space
Key exclusion criteria (11 listed)
- Not a surgical candidate
- Skeletally Immature
- Acetabular Dysplasia (LCEA < 20)
- Tonnis 2+ OA
- Previous ipsilateral hip surgery
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
Hip disability and Osteoarthritis Outcome Score (HOOS)
Time frame: Pre operative (Baseline), change from baseline HOOS at 3 months, change from baseline HOOS at 6 months, change from baseline HOOS at 1 year, and change from baseline HOOS at 2 year.
HOOS is a questionnaire constructed to assess patient-relevant outcomes in five separate sub-scales (pain, symptoms, activity of daily living, sport and recreation function and hip-related quality of life). HOOS is scored 0-100 with higher scores being the best outcome.
Short Form Health Survey (SF-12)
Time frame: Pre operative (Baseline), change from baseline SF-12 at 3 months, change from baseline SF-12 at 6 months, change from baseline SF-12 at 1 year, and change from baseline SF-12 at 2 year
The SF-12 is a shortened, validated, patient-reported survey of patient health with questions pulled directly from the longer form SF-36. SF-12 is scored 0-100 with higher scores being the best outcome.
Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference (PI)
Time frame: Pre operative (Baseline), change from baseline PROMIS - PI at 3 months, change from baseline PROMIS - PI at 6 months, change from baseline PROMIS -PI at 1 year, and change from baseline PROMIS - PI at 2 year
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's pain interference. PROMIS - PI is scored from 38.7-83.8 with the lower scores being the best outcome.
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function (PF)
Time frame: Pre operative (Baseline), change from baseline PROMIS - PF at 3 months, change from baseline PROMIS - PF at 6 months, change from baseline PROMIS -PF at 1 year, and change from baseline PROMIS - PF at 2 year
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's physical function. PROMIS - PF is scored from 14.7-75.6 with the higher scores being the best outcome.
Patient-Reported Outcomes Measurement Information System (PROMIS) - Mobility (M)
Time frame: Pre operative (Baseline), change from baseline PROMIS - M at 3 months, change from baseline PROMIS - M at 6 months, change from baseline PROMIS -M at 1 year, and change from baseline PROMIS - M at 2 year
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's mobility. PROMIS - M is scored from 18.2-60.2 with the higher scores being the best outcome.
Patient-Reported Outcomes Measurement Information System (PROMIS) - Depression (D)
Time frame: Pre operative (Baseline), change from baseline PROMIS - D at 3 months, change from baseline PROMIS - D at 6 months, change from baseline PROMIS - D at 1 year, and change from baseline PROMIS - D at 2 year
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's depression. PROMIS - D is scored from 34.2-84.4 with the lower scores being the best outcome.
Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety (A)
Time frame: Pre operative (Baseline), change from baseline PROMIS - A at 3 months, change from baseline PROMIS - A at 6 months, change from baseline PROMIS - A at 1 year, and change from baseline PROMIS - A at 2 year
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This specific PROMIS survey assesses a patient's anxiety. PROMIS - A is scored from 32.9-84.9 with the lower scores being the best outcome.
5 secondary outcomes
University of California Los Angeles Activity Score (UCLA Score)
Time frame: Pre operative (Baseline), change from baseline UCLA Score at 3 months, change from baseline UCLA Score at 6 months, change from baseline UCLA Score at 1 year, and change from baseline UCLA Score at 2 year
International Hip Outcome Tool (iHot-12)
Time frame: Pre operative (Baseline), change from baseline iHOT-12 at 3 months, change from baseline iHOT-12 at 6 months, change from baseline iHOT-12 at 1 year, and change from baseline iHOT-12 at 2 year
Modified Harris Hip Score (mHHS)
Time frame: Pre operative (Baseline), change from baseline mHHS at 3 months, change from baseline mHHS at 6 months, change from baseline mHHS at 1 year, and change from baseline mHHS at 2 year
Brief Resilience Scale (BRS)
Time frame: Pre operative (Baseline)
Mobility, Stability, and Pain (MSP Question)
Time frame: Pre operative (Baseline), 3 months, 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
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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.
John C Clohisy, MD principal investigator
Washington University School of Medicine
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoracetabular Impingement, run by Washington University School of Medicine at 13 sites in 2 countries.
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 7 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Hip disability and Osteoarthritis Outcome Score (HOOS) (time frame: Pre operative (Baseline), change from baseline HOOS at 3 months, change from baseline HOOS at 6 months, change from baseline HOOS at 1 year, and change from baseline HOOS at 2 year.). The study lists 7 primary outcomes in all. 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 3 Oct 2025.