An Evaluation of Hip Preservation Outcomes

A Comparison of Total Hip Arthroplasty and Hip Preservation Outcomes

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

Study Overview

• Status: Recruiting
• Conditions: Femoroacetabular Impingement; Hip Arthroscopy
• Intervention / Treatment: Procedure: Hip Arthroscopy

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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Andrew Jimenez, MD; Phone Number: 813-295-3523; Email: andrew.jimenez@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale New Haven Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients age 12 years and older who are candidates for surgical intervention of the hip.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants Undergoing Hip Preservation/Surgical Interventions; Data will be prospectively collected on participants undergoing hip preservation at Yale-New Haven Hospital.	Procedure: Hip Arthroscopy; Hip Preservation surgeries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hip Outcome Score (iHOT-12)	iHOT-12 is a 12-item questionnaire scored using a visual analog scale from 0 to 100, with a score of 100 being the best function and least amount of symptoms, and the overall mean equates to the final iHOT score.	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)	The HOS is a self-administered questionnaire with a scoring system composed of 2 sub-scales. The 19 item Activities of Daily Living (ADL) sub-scale and a 9 item Sports sub-scale. Both have a range of scores from 0 to 4, with 0 being 'unable to do' and 4, 'no difficulty'. N/A is also an option. The total score for each is multiplied by 4 with the highest potential ADL score bing no greater than 68 and the sports scale with the highest potential score being 36. An overall higher score from both sub-scales indicates a greater level of function.	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	PROMIS Physical function is a standardized computer adapted test which is able to quickly and effectively score patients on a scale of 0 (not able to function) to 100 (fully functional) based on their physical function. 100 would be a perfect score and 0 would be the worst possible score. Higher scores indicate better physical function.	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	The Chicago sports score asks athletes questions pertaining to their ability to return to sport. If they are able to return to sport it asks questions about their ability level since returning. Similarly, if they are not able to return to sport it asks questions regarding what has held them back. It is on a 100 point scale with 100 being the best possible outcome and 0 the lowest possible score. Higher scores indicate better ability to return to sports.	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)	Participants will be asked to estimate their pain on a VAS from 0 to 10, where 0 is considered to be no pain at all and 10 is considered to be the worst possible pain.	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	Participants will receive the PROMIS pain interference, physical function, and global health modules to assess quality of life, a commonly used general health quality of life assessment tool. PROMIS pain interference is a standardized computer adapted test which is able to quickly and effectively score patients on a scale of 0-100 based on how pain affects their day to day life. 100 would be a perfect score and 0 would be the worst possible score. Higher scores indicate less pain interference on quality of life.	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	The PROMIS Global-10 is a 10-item patient-reported questionnaire that measures changes in general health in which the response options are presented as 5-point scale, 5 (without any difficulty) to 1 (Unable to do). Higher scores indicate a healthier patient.	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

Outcome Measure	Measure Description	Time Frame
Change in Patients Satisfaction Post Surgery	Participants will be asked to rate their level of satisfaction after surgery with 10 being extremely satisfied and 0 being not satisfied at all.	3 months, 6 months, 1 year, 2 year, 5 year and 10 year
Psychometric thresholds of success will be assessed using anchor questions	Participants will be asked anchor questions which will be used to determine psychometric thresholds of success the psychometric threshold substantial clinical benefit (SCB). They will be asked whether they feel that their current symptoms are acceptable or not to them. This helps to establish the patient acceptable symptomatic state (PASS). They will also be asked whether they feel that their hip is better worse or no different compared to before surgery. This will establish the psychometric threshold SCB.	up to 10 years

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Arthrex, Inc.
• Investigators: Principal Investigator: Andrew Jimenez, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2023
• Primary Completion (Estimated): June 1, 2053
• Study Completion (Estimated): June 1, 2053

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Femoracetabular Impingement
• Other Study ID Numbers: 2000032269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participant outcomes and demographic data will be shared with other researchers for the purpose of collaboration.
• IPD Sharing Time Frame: Beginning 12 months and ending 36 months following primary publication.
• IPD Sharing Access Criteria: Proposals should be directed to andrew.jimenez@yale.edu. To gain access, data requestors may need to sign a data use access/use agreement and have approval from an institutional review board/ethics board for the proposed use of such data.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No