An Evaluation of Hip Preservation Outcomes

NCT05746533 | Recruiting DMC

• 1 other identifier: 2000032269
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hip Arthroscopy; Femoroacetabular Impingement

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Change in Patients Satisfaction Post Surgery

  3 months, 6 months, 1 year, 2 year, 5 year and 10 year

• Psychometric thresholds of success will be assessed using anchor questions

  up to 10 years

Study Arms (1)

Participants Undergoing Hip Preservation/Surgical Interventions

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

Procedure: Hip Arthroscopy

Interventions

Hip Arthroscopy PROCEDURE

Hip Preservation surgeries

Participants Undergoing Hip Preservation/Surgical Interventions

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Arthrex, Inc.: collaborator

Study Sites (1)

Yale New Haven Health

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Jimenez, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Jimenez, MD

CONTACT

813-295-3523; andrew.jimenez@yale.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: February 27, 2023
• Study Start: June 2, 2023
• Primary Completion (Estimated): June 1, 2053
• Study Completion (Estimated): June 1, 2053
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Beginning 12 months and ending 36 months following primary publication.
• 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.

Locations

US (1)