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Recruiting NCT05746533

An Evaluation of Hip Preservation Outcomes

— Observational Hip Arthroscopy Femoroacetabular Impingement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hip Arthroscopy.
Who it may be relevant to
Registry conditions: Hip Arthroscopy, Femoroacetabular Impingement. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Comparison of Total Hip Arthroplasty and Hip Preservation Outcomes

Overview

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

Detailed description

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.

Interventions

  • Procedure Hip Arthroscopy
    Hip Preservation surgeries

Primary outcome measures

  • Change in Hip Outcome Score (iHOT-12) [Time frame: Baseline, 3 months post-operatively, 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively]
  • Change in Hip Outcome Score (HOS) [Time frame: Baseline, 3 months post-operatively, 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively]
  • Change in PROMIS questionnaire Score [Time frame: Baseline, 3 months post-operatively, 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively]
  • Change in Sports Survey Score [Time frame: Baseline, 3 months post-operatively, 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively]
  • Change in Pain Score using a visual analog scale (VAS) [Time frame: Baseline, 3 months post-operatively, 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively]
  • Change in PROMIS Pain Interference [Time frame: Baseline, 3 months post-operatively, 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively]
  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 [Time frame: Baseline, 3 months post-operatively, 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively]
Secondary outcome measures (2)
  • Change in Patients Satisfaction Post Surgery [Time frame: 3 months, 6 months, 1 year, 2 year, 5 year and 10 year]
  • Psychometric thresholds of success will be assessed using anchor questions [Time frame: up to 10 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Yale New Haven Health — New Haven

Identifiers

NCT: NCT05746533 · 2000032269

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗