Healthy Hip Study: Conservative Management for Pre-arthritic Hip Disorders

NCT ID: NCT04069507

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-15

Study Completion Date

2024-09-22

Brief Summary

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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

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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

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Femoroacetabular Impingement Acetabular Dysplasia Acetabular Labrum Tear Hip Pain Rehabilitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Abby Cheng

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abby L Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 27117727 (View on PubMed)

Prather 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.

Reference Type BACKGROUND
PMID: 29111466 (View on PubMed)

Hunt 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.

Reference Type BACKGROUND
PMID: 22595328 (View on PubMed)

Prather 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.

Reference Type BACKGROUND
PMID: 31059595 (View on PubMed)

Prather 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.

Reference Type BACKGROUND
PMID: 28629805 (View on PubMed)

Prather 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.

Reference Type BACKGROUND
PMID: 28158964 (View on PubMed)

Other Identifiers

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1K23AR074520-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201807150

Identifier Type: -

Identifier Source: org_study_id

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