An Evaluation of Hip Preservation Outcomes

NCT ID: NCT05746533

Last Updated: 2025-04-29

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

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-02

Study Completion Date

2053-06-30

Brief Summary

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The purpose of this study is to assess outcomes of hip preservation surgeries including open and arthroscopic treatment of femoroacetabular impingement (FAI).

Detailed Description

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The purpose of this study is to assess outcomes of hip preservation surgeries including open and arthroscopic treatment of femoroacetabular impingement (FAI). Data will be prospectively and retrospectively collected on about 10,000 patients undergoing hip preservation at Yale-New Haven Hospital. Patients who are candidates for surgical intervention of the hip are potential participants.

The primary objective of this study is to determine whether hip arthroscopy reduces or improves post-operative outcome measures compared to pre-operative measures (including patient reported outcomes \[PROs\], revision surgery, conversion to total hip arthroplasty, and return to sport) in patients with FAI and labral tears.

The secondary objective of this study is to be able to better gauge (by assessments of patient satisfaction and psychometric thresholds of success) the progress made by recent advancements in arthroscopic hip preservation procedures with longitudinal follow-up.

The focus of this clinical trial will be the data collected prospectively.

Conditions

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Hip Arthroscopy Femoroacetabular Impingement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants Undergoing Hip Preservation/Surgical Interventions

Data will be prospectively collected on participants undergoing hip preservation at Yale-New Haven Hospital.

Hip Arthroscopy

Intervention Type PROCEDURE

Hip Preservation surgeries

Interventions

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Hip Arthroscopy

Hip Preservation surgeries

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Candidates for surgical intervention of the hip
* Participant and/or guardian has given informed consent and assent as applicable.

Exclusion Criteria

* Documented history of pre-existing hip conditions (SCFE, LCPD, acetabular fractures)
* Has language or cognitive barriers preventing understanding of study and consent and assent documents
* Prior revision surgeries
* Patients from the trauma/emergency department
* Individuals with Unusable x-rays
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arthrex, Inc.

INDUSTRY

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Jimenez, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale New Haven Health

New Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Andrew Jimenez, MD

Role: CONTACT

813-295-3523

Other Identifiers

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2000032269

Identifier Type: -

Identifier Source: org_study_id

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