- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02408276
Longitudinal Evaluation of Hip Cartilage Degeneration: FAI
Longitudinal Evaluation of Hip Cartilage Degeneration: the Effect of Femoroacetabular Impingement
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Stephen Lyman, PhD
- Phone Number: 646-714-6460
- Email: lymans@hss.edu
Study Contact Backup
- Name: Bryan Kelly, MD
- Phone Number: 2126061159
- Email: Kellyb@hss.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Recruiting
- Hospital for Special Surgery
-
Contact:
- Stephen Lyman, PhD
- Phone Number: 646-714-6460
- Email: lymans@hss.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients 35 years of age or younger enrolled in the HSS Hip Preservation Registry prior to September 30, 2016 with an MRI confirmed diagnosis of FAI will be eligible for inclusion in this study regardless of surgery status.
- Patients who agree to participate must complete a baseline questionnaire consisting of: 1) Modified Harris Hip Score (MHHS), an overall measure of hip condition; 2) the Hip Outcome Score (HOS), a measure developed specifically for younger active patients that measures quality of life and levels of sports and recreation; and 3) International Hip Outcome Tool (iHOT33), a newly developed hip specific outcome score, which measures a number of subscores relating to physical and social functioning with hip problems.
Exclusion Criteria:
- Patients over age 35 will be excluded as the focus of this study is early changes that may predispose to later degenerative changes.
- Patients undergoing revision hip arthroscopy as their first treatment in the Registry will not be eligible, as these are patients who have failed initial therapy.
- Patients with no complete questionnaires at any time point will be excluded.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
dGEMERIC MRI technique
All tests and imaging are part of standard of care except follow up MRI, which will be performed in a random group from within the cohort and paid for through this grant.
|
Patients will be treated surgically (hip arthroscopy) or nonoperatively (physical therapy) and pain medications as needed. For surgical patients, cartilage samples and surgeon operative reports will be a source of research. For both cohorts, MRIs, radiographs and patient reported outcome surveys will be additional research sources. All tests and imaging are part of standard of care except follow up MRI, which will be performed in a random group from within the cohort and paid for through this grant. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
degree of cartilage degeneration
Time Frame: 5 years post operation
|
degree of cartilage degeneration at 5 years post-presentation based on changes in cartilage morphology assessed using MRI (a two-dimensional fast spin echo sequence in the coronal and sagittal planes).
|
5 years post operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
dGEMERIC MRI measurements
Time Frame: 2 year post operation
|
We will use MRI to localize and measure chondral and labral abnormalities to determine whether extent, location, or type of defect affect the outcome of hip arthroscopy in FAI.
|
2 year post operation
|
Collaborators and Investigators
Investigators
- Principal Investigator: Stephen Lyman, PhD, Hospital for Special Surgery, New York
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-168
- R01AR066069-01 (U.S. NIH Grant/Contract)
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 Femoroacetabular Impingement
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Ottawa Hospital Research InstituteCompleted
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Schulthess KlinikCompletedSymptomatic Femoroacetabular ImpingementSwitzerland
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Ottawa Hospital Research InstituteCompletedFemoroacetabular Hip Impingement SyndromeCanada
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Ramsay Générale de SantéRamsay santéRecruiting
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Horsens HospitalUniversity of Aarhus; La Trobe UniversityNot yet recruitingFemoroacetabular Impingement
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American Hip InstituteStryker OrthopaedicsRecruitingFemoroacetabular ImpingementUnited States
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Universitaire Ziekenhuizen KU LeuvenActive, not recruitingFemoroacetabular ImpingementBelgium
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McMaster UniversityCanadian Institutes of Health Research (CIHR); McMaster Surgical Association; Arthroscopy Association of North America and other collaboratorsActive, not recruitingFemoroacetabular ImpingementCanada, Netherlands, Korea, Republic of
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The Hawkins FoundationTerminated
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Peking University Third HospitalCompletedFemoroacetabular ImpingementChina
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