Clinical Trial Finder

An Evaluation of Hip Preservation Outcomes

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 12 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05746533
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Yale University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Andrew Jimenez, MD
Principal Investigator Affiliation Yale University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Hip Arthroscopy, Femoroacetabular Impingement
Additional Details

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.

Arms & Interventions

Arms

: Participants Undergoing Hip Preservation/Surgical Interventions

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

Interventions

Procedure: - Hip Arthroscopy

Hip Preservation surgeries

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Yale New Haven Health, New Haven, Connecticut

Status

Recruiting

Address

Yale New Haven Health

New Haven, Connecticut, 06520

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