Clinical trial NCT05746533: An Evaluation of Hip Preservation Outcomes
Official title: A Comparison of Total Hip Arthroplasty and Hip Preservation Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip Arthroscopy
Femoroacetabular Impingement
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Arthrex, Inc.
First posted: 2023-02-27
Enrollment: 10000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients age 12 years and older who are candidates for surgical intervention of the hip.

Brief summary: 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.

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

Primary outcomes:
measure: Change in Hip Outcome Score (iHOT-12)
timeFrame: 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
measure: Change in Hip Outcome Score (HOS)
timeFrame: 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
measure: Change in PROMIS questionnaire Score
timeFrame: 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
measure: Change in Sports Survey Score
timeFrame: 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
measure: Change in Pain Score using a visual analog scale (VAS)
timeFrame: 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
measure: Change in PROMIS Pain Interference
timeFrame: 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
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10
timeFrame: 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 outcomes:
measure: Change in Patients Satisfaction Post Surgery
timeFrame: 3 months, 6 months, 1 year, 2 year, 5 year and 10 year
measure: Psychometric thresholds of success will be assessed using anchor questions
timeFrame: up to 10 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Health
state: Connecticut
Study officials:
affiliation: Yale University
name: Andrew Jimenez, MD
role: PRINCIPAL_INVESTIGATOR
References: