Healthy Hip Study: Conservative Management for Pre-arthritic Hip Disorders (HHS)
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|ClinicalTrials.gov Identifier: NCT04069507|
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : October 21, 2019
|Condition or disease|
|Femoroacetabular Impingement Acetabular Dysplasia Acetabular Labrum Tear Hip Pain Rehabilitation|
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 Type :||Observational|
|Estimated Enrollment :||250 participants|
|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|
- 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.
- 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
- 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)
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
|Contact: Melissa Armbrechtfirstname.lastname@example.org|
|Contact: Abby L Cheng, MD||314-747-2828||ChengAL@wustl.edu|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Melissa Armbrecht 314-747-2828 ArmbrechtM@wustl.edu|
|Principal Investigator:||Abby L Cheng, MD||Washington University School of Medicine|