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

March 24, 2025 updated by: Abby Cheng, Washington University School of Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 40 years (Child, Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 Year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
12 Weeks
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)
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Abby L Cheng, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 22, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201807150
  • 1K23AR074520-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acetabular Labrum Tear

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings