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Healthy Hip Study: Conservative Management for Pre-arthritic Hip Disorders (HHS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069507
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : October 21, 2019
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Abby Cheng, Washington University School of Medicine

Brief 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 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.

Condition or disease
Femoroacetabular Impingement Acetabular Dysplasia Acetabular Labrum Tear Hip Pain Rehabilitation

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.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Healthy Hip Study: Predictors of Successful Conservative Management for Pre-arthritic Hip Disorders: Prospective Study
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : September 22, 2021
Estimated Study Completion Date : September 22, 2021



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Rate of adherence and symptom response to movement pattern training [ Time Frame: 12 Weeks ]
    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

  2. Rate of clinically meaningful improvement with conservative management [ Time Frame: 1 Year ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069507


Contacts
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Contact: Melissa Armbrecht 314-747-2828 armbrechtm@wustl.edu
Contact: Abby L Cheng, MD 314-747-2828 ChengAL@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Melissa Armbrecht    314-747-2828    ArmbrechtM@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Abby L Cheng, MD Washington University School of Medicine
Publications:

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Responsible Party: Abby Cheng, Assistant Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04069507    
Other Study ID Numbers: 201807150
1K23AR074520-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abby Cheng, Washington University School of Medicine:
Biopsychosocial health
Clinical prediction tool
Patient-reported outcomes
Movement pattern training
Additional relevant MeSH terms:
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Femoracetabular Impingement
Hip Dislocation, Congenital
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Musculoskeletal Abnormalities
Congenital Abnormalities