Femoroacetabular ImpingementHHSNCT04069507
Healthy Hip Study: Conservative Management for Pre-arthritic Hip Disorders
An observational study of Femoroacetabular Impingement and Acetabular Dysplasia, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Pre-arthritic hip disorders can cause pain, interfere with daily activities and exercise, and lead to the development of osteoarthritis in young adults. Surgical and conservative treatment options are being developed and studied, but it is currently unclear why some patients improve with a particular treatment plan… Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Femoroacetabular Impingement, Acetabular Dysplasia, Acetabular Labrum Tear
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2019to 22 Sep 2024
- 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants will be recruited from patients who present to a single tertiary care academic orthopedic department. Potentially eligible patients will have presented to an orthopedic surgeon or sports medicine physiatrist for a new evaluation of hip pain.
Who may be able to join
- Clinically suspected intra-articular hip joint pain
- One or more of the following radiographic/MRI findings: Femoroacetabular impingement, acetabular dysplasia, acetabular labral tear, acetabular retroversion, femoral anteversion, hip microinstability, and/or normal radiographs
Who cannot join
- Surgery recommended and/or scheduled at initial clinic evaluation
- "At-risk" acetabular dysplasia (Lateral center edge angle < 15 degrees)
- Other intra-articular hip diagnoses including: Slipped capital femoral epiphysis, Legg-Calve-Perthes disease, Avascular necrosis
- Moderate or severe hip osteoarthritis (Tonnis grade 2 or 3)
- Hip/pelvis weakness from brain/nerve disorder (Ex: lumbosacral radiculopathy with weakness, cerebral palsy)
- Previous same-side hip surgery, hip fracture, hip infection, and/or hip tumor
- Inflammatory arthropathy
- Known pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Healthy Hip Study: Predictors of Successful Conservative Management for Pre-arthritic Hip Disorders: Prospective Study
Pre-arthritic hip disorders can cause pain, interfere with daily activities and exercise, and lead to the development of osteoarthritis in young adults. Surgical and conservative treatment options are being developed and studied, but it is currently unclear why some patients improve with a particular treatment plan while others do not. The goal of this research project is to develop a tool that predicts which combination of treatment options will be most effective for each individual patient.
Read the detailed description
Significance: Pre-arthritic hip disorders (PAHD) are bony and soft tissue hip morphologies that predispose adolescents and young adults to developing hip pain, chronic impairment, and early osteoarthritis (OA). Proper management may prevent these sequelae, but current evidence, especially regarding non-operative treatment options, is limited.
Innovation: The majority of PAHD has so far addressed identification and correction of abnormal hip anatomy via surgical management. However, a growing body of evidence suggests that several other variables including patients' functional goals, movement patterns, and psychological profiles also affect their symptomatology. These risk factors are modifiable but are not routinely or adequately addressed. The innovation of this project is to improve patient outcomes by evaluating patients with a more comprehensive, patient-specific approach than is currently the standard of care.
Purpose: The purpose of this project is to identify predictors of response to non-operative PAHD treatment options and to synthesize these predictors into a clinical prediction tool that informs non-operative one-year outcomes using data available during patients' initial evaluation. In this prospective observational study, patients who present to an orthopedic physician for PAHD will be provided instruction on movement pattern training, which is a standardized activity modification protocol that addresses how patients perform routine and strenuous activities in order to reduce hip pain. It has proven to be efficacious in a randomized trial setting, but it is not yet widely discussed by physicians in the clinic setting. Patients will report adherence and response to the movement pattern training at scheduled intervals for 12 weeks, and they will also report persistent hip-related dysfunction and/or progression to surgery at 6 and 12 months. A clinical prediction tool of one-year outcomes will be developed using patients' demographics, biopsychosocial profile, movement and activity patterns, and anatomy as candidate predictors. The analysis will also determine a minimum combination of patient-reported outcome measures (PROMs) that reduces survey burden while maintaining similar predictive utility when compared to administration of a full battery of hip-specific and general health PROMs.
Impact: This study is the first step in creating and validating a clinical prediction tool which will guide management for patients with pre-arthritic hip disorders. This line of research will equip clinicians to provide more accurate prognostic counseling at initial evaluation so that an informed shared decision can be made with the patient and initiation of an appropriate comprehensive management plan can be expedited.
- Conditions
- Femoroacetabular Impingement, Acetabular Dysplasia, Acetabular Labrum Tear, Hip Pain, Rehabilitation
- Keywords
- Biopsychosocial health, Clinical prediction tool, Patient-reported outcomes, Movement pattern training
- Medical subject headings
- Femoracetabular Impingement, Hip Dislocation
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful conservative management
Percentage of participants who self-report satisfactory overall hip symptoms and no plan to proceed with surgery. The rate will be adjusted for patients' baseline demographics, severity of hip symptoms, biopsychosocial profile, hypermobility profile, movement and activity patterns, and hip anatomy.
Measured: 1 Year
Secondary outcomes (2)
Rate of adherence and symptom response to movement pattern training
Percentage of participants who are adherent to the movement pattern training protocol for at least one study interval and who report at least moderate symptomatic improvement on a Global Rating of Change scale as a result of adherence
Measured: 12 Weeks
Rate of clinically meaningful improvement with conservative management
Percentage of participants who do not proceed to hip surgery and who either self-report satisfactory overall hip symptoms or meet the minimal clinically important difference (MCID) on the International Hip Outcome Tool-12 (iHOT-12)
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start15 Oct 2019
- Primary completion22 Sep 2023
- Study completion22 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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 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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Abby Cheng, Washington University School of Medicine
- Investigators
- Abby L Cheng, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069507
- Sponsor's protocol ID
- 201807150
- Other IDs
- 1K23AR074520-01A1
- Acronym
- HHS
- Status last verified
- Mar 2025
- First submitted
- 21 Aug 2019
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators are amenable to sharing individual participant data (IPD) when all anticipated data analyses are complete. However, the data generated from this study may be used for future validation efforts of new versions of the clinical prediction tool. The IPD will likely not be made available until there is reasonable confidence that no further data analyses are planned.
Publications
Harris-Hayes M, Czuppon S, Van Dillen LR, Steger-May K, Sahrmann S, Schootman M, Salsich GB, Clohisy JC, Mueller MJ. Movement-Pattern Training to Improve Function in People With Chronic Hip Joint Pain: A Feasibility Randomized Clinical Trial. J Orthop Sports Phys Ther. 2016 Jun;46(6):452-61. doi: 10.2519/jospt.2016.6279. Epub 2016 Apr 26.
PubMed 27117727Prather H, Creighton A, Sorenson C, Simpson S, Reese M, Hunt D, Rho M. Anxiety and Insomnia in Young and Middle-Aged Adult Hip Pain Patients With and Without Femoroacetabular Impingement and Developmental Hip Dysplasia. PM R. 2018 May;10(5):455-461. doi: 10.1016/j.pmrj.2017.10.007. Epub 2017 Oct 27.
PubMed 29111466Hunt D, Prather H, Harris Hayes M, Clohisy JC. Clinical outcomes analysis of conservative and surgical treatment of patients with clinical indications of prearthritic, intra-articular hip disorders. PM R. 2012 Jul;4(7):479-87. doi: 10.1016/j.pmrj.2012.03.012. Epub 2012 May 16.
PubMed 22595328Prather H, Decker G, Bonnette M, Simpson S, Hunt D, Sahrmann S, Cheng A, Nepple J. Hip Radiograph Findings in Patients Aged 40 Years and Under with Posterior Pelvic Pain. PM R. 2019 Aug;11 Suppl 1:S46-S53. doi: 10.1002/pmrj.12180. Epub 2019 Jul 25.
PubMed 31059595Prather H, Cheng A, Steger-May K, Maheshwari V, VanDillen L. Association of Hip Radiograph Findings With Pain and Function in Patients Presenting With Low Back Pain. PM R. 2018 Jan;10(1):11-18. doi: 10.1016/j.pmrj.2017.06.003. Epub 2017 Jun 16.
PubMed 28629805Prather H, Cheng A, Steger-May K, Maheshwari V, Van Dillen L. Hip and Lumbar Spine Physical Examination Findings in People Presenting With Low Back Pain, With or Without Lower Extremity Pain. J Orthop Sports Phys Ther. 2017 Mar;47(3):163-172. doi: 10.2519/jospt.2017.6567. Epub 2017 Feb 3.
PubMed 28158964Cheng AL, Pashos MM, Hannemann AJ, Brady BK, Huecker JB, Steger-May K, Prather H, Clohisy JC, Harris-Hayes M. Predictors and rate of satisfactory response to nonoperative management for nonarthritic hip-related pain. PM R. 2026 Aug;18(8):852-862. doi: 10.1002/pmrj.70085. Epub 2026 Jan 27.
PubMed 41589432Cheng AL, Hannemann AJ, Brady BK, Pashos MM, Huecker JB, Steger-May K, Prather H, Clohisy JC, Harris-Hayes M. Patients' real-world engagement with movement pattern modifications for nonarthritic hip-related pain. PM R. 2025 Jul;17(7):761-770. doi: 10.1002/pmrj.13343. Epub 2025 Feb 15.
PubMed 39953925
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Hip Study: Predictors of Successful Conservative Management for Pre-arthritic Hip Disorders: Prospective Study
- ClinicalTrials.gov ID
- NCT04069507
- Acronym / sponsor ID
- HHS / 201807150
- Conditions
- Femoroacetabular Impingement, Acetabular Dysplasia, Acetabular Labrum Tear, Hip Pain, Rehabilitation
- Keywords
- Biopsychosocial health, Clinical prediction tool, Patient-reported outcomes, Movement pattern training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Sep 2024 (actual)
- First posted
- 28 Aug 2019 (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.
Pre-arthritic hip disorders can cause pain, interfere with daily activities and exercise, and lead to the development of osteoarthritis in young adults. Surgical and conservative treatment options are being developed and studied, but it is currently unclear why some patients improve with a particular treatment plan while others do not. The goal of this research project is to develop a tool that predicts which combination of treatment options will be most effective for each individual patient.
Detailed description
Significance: Pre-arthritic hip disorders (PAHD) are bony and soft tissue hip morphologies that predispose adolescents and young adults to developing hip pain, chronic impairment, and early osteoarthritis (OA). Proper management may prevent these sequelae, but current evidence, especially regarding non-operative treatment options, is limited.
Innovation: The majority of PAHD has so far addressed identification and correction of abnormal hip anatomy via surgical management. However, a growing body of evidence suggests that several other variables including patients' functional goals, movement patterns, and psychological profiles also affect their symptomatology. These risk factors are modifiable but are not routinely or adequately addressed. The innovation of this project is to improve patient outcomes by evaluating patients with a more comprehensive, patient-specific approach than is currently the standard of care.
Purpose: The purpose of this project is to identify predictors of response to non-operative PAHD treatment options and to synthesize these predictors into a clinical prediction tool that informs non-operative one-year outcomes using data available during patients' initial evaluation. In this prospective observational study, patients who present to an orthopedic physician for PAHD will be provided instruction on movement pattern training, which is a standardized activity modification protocol that addresses how patients perform routine and strenuous activities in order to reduce hip pain. It has proven to be efficacious in a randomized trial setting, but it is not yet widely discussed by physicians in the clinic setting. Patients will report adherence and response to the movement pattern training at scheduled intervals for 12 weeks, and they will also report persistent hip-related dysfunction and/or progression to surgery at 6 and 12 months. A clinical prediction tool of one-year outcomes will be developed using patients' demographics, biopsychosocial profile, movement and activity patterns, and anatomy as candidate predictors. The analysis will also determine a minimum combination of patient-reported outcome measures (PROMs) that reduces survey burden while maintaining similar predictive utility when compared to administration of a full battery of hip-specific and general health PROMs.
Impact: This study is the first step in creating and validating a clinical prediction tool which will guide management for patients with pre-arthritic hip disorders. This line of research will equip clinicians to provide more accurate prognostic counseling at initial evaluation so that an informed shared decision can be made with the patient and initiation of an appropriate comprehensive management plan can be expedited.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants will be recruited from patients who present to a single tertiary care academic orthopedic department. Potentially eligible patients will have presented to an orthopedic surgeon or sports medicine physiatrist for a new evaluation of hip pain.
Key inclusion criteria (2 listed)
- Clinically suspected intra-articular hip joint pain
- One or more of the following radiographic/MRI findings: Femoroacetabular impingement, acetabular dysplasia, acetabular labral tear, acetabular retroversion, femoral anteversion, hip microinstability, and/or normal radiographs
Key exclusion criteria (8 listed)
- Surgery recommended and/or scheduled at initial clinic evaluation
- "At-risk" acetabular dysplasia (Lateral center edge angle < 15 degrees)
- Other intra-articular hip diagnoses including: Slipped capital femoral epiphysis, Legg-Calve-Perthes disease, Avascular necrosis
- Moderate or severe hip osteoarthritis (Tonnis grade 2 or 3)
- Hip/pelvis weakness from brain/nerve disorder (Ex: lumbosacral radiculopathy with weakness, cerebral palsy)
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
Rate of successful conservative management
Time frame: 1 Year
Percentage of participants who self-report satisfactory overall hip symptoms and no plan to proceed with surgery. The rate will be adjusted for patients' baseline demographics, severity of hip symptoms, biopsychosocial profile, hypermobility profile, movement and activity patterns, and hip anatomy.
2 secondary outcomes
Rate of adherence and symptom response to movement pattern training
Time frame: 12 Weeks
Rate of clinically meaningful improvement with conservative management
Time frame: 1 Year
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 28 Mar 2025.
- Background: PubMed 27117727Harris-Hayes M, Czuppon S, Van Dillen LR, Steger-May K, Sahrmann S, Schootman M, Salsich GB, Clohisy JC, Mueller MJ. Movement-Pattern Training to Improve Function in People With Chronic Hip Joint Pain: A Feasibility Randomized Clinical Trial. J Orthop Sports Phys Ther. 2016 Jun;46(6):452-61. doi: 10.2519/jospt.2016.6279. Epub 2016 Apr 26.
- Background: PubMed 29111466Prather H, Creighton A, Sorenson C, Simpson S, Reese M, Hunt D, Rho M. Anxiety and Insomnia in Young and Middle-Aged Adult Hip Pain Patients With and Without Femoroacetabular Impingement and Developmental Hip Dysplasia. PM R. 2018 May;10(5):455-461. doi: 10.1016/j.pmrj.2017.10.007. Epub 2017 Oct 27.
- Background: PubMed 22595328Hunt D, Prather H, Harris Hayes M, Clohisy JC. Clinical outcomes analysis of conservative and surgical treatment of patients with clinical indications of prearthritic, intra-articular hip disorders. PM R. 2012 Jul;4(7):479-87. doi: 10.1016/j.pmrj.2012.03.012. Epub 2012 May 16.
- Background: PubMed 31059595Prather H, Decker G, Bonnette M, Simpson S, Hunt D, Sahrmann S, Cheng A, Nepple J. Hip Radiograph Findings in Patients Aged 40 Years and Under with Posterior Pelvic Pain. PM R. 2019 Aug;11 Suppl 1:S46-S53. doi: 10.1002/pmrj.12180. Epub 2019 Jul 25.
- Background: PubMed 28629805Prather H, Cheng A, Steger-May K, Maheshwari V, VanDillen L. Association of Hip Radiograph Findings With Pain and Function in Patients Presenting With Low Back Pain. PM R. 2018 Jan;10(1):11-18. doi: 10.1016/j.pmrj.2017.06.003. Epub 2017 Jun 16.
- Background: PubMed 28158964Prather H, Cheng A, Steger-May K, Maheshwari V, Van Dillen L. Hip and Lumbar Spine Physical Examination Findings in People Presenting With Low Back Pain, With or Without Lower Extremity Pain. J Orthop Sports Phys Ther. 2017 Mar;47(3):163-172. doi: 10.2519/jospt.2017.6567. Epub 2017 Feb 3.
- Derived from this study: PubMed 41589432Cheng AL, Pashos MM, Hannemann AJ, Brady BK, Huecker JB, Steger-May K, Prather H, Clohisy JC, Harris-Hayes M. Predictors and rate of satisfactory response to nonoperative management for nonarthritic hip-related pain. PM R. 2026 Aug;18(8):852-862. doi: 10.1002/pmrj.70085. Epub 2026 Jan 27.
- Derived from this study: PubMed 39953925Cheng AL, Hannemann AJ, Brady BK, Pashos MM, Huecker JB, Steger-May K, Prather H, Clohisy JC, Harris-Hayes M. Patients' real-world engagement with movement pattern modifications for nonarthritic hip-related pain. PM R. 2025 Jul;17(7):761-770. doi: 10.1002/pmrj.13343. Epub 2025 Feb 15.
- Individual participant dataSharing planned: Undecided. The investigators are amenable to sharing individual participant data (IPD) when all anticipated data analyses are complete. However, the data generated from this study may be used for future validation efforts of new versions of the clinical prediction tool. The IPD will likely not be made available until there is reasonable confidence that no further data analyses are planned.
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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.
Abby L Cheng, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoroacetabular Impingement and Acetabular Dysplasia, run by Washington University School of Medicine at 1 site in United States.
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 8 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 28 Mar 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 United States. 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?
Rate of successful conservative management (time frame: 1 Year). 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 NCT04069507, which also lists 8 linked publications.
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 28 Mar 2025.