An Evaluation of Hip Preservation Outcomes

Femoroacetabular Impingement Clinical Trial

Official title:

A Comparison of Total Hip Arthroplasty and Hip Preservation Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05746533
• Other study ID #: 2000032269
• Status: Recruiting
• Start date: June 2, 2023
• Est. completion date: June 2053

Study information

• Verified date: August 2023
• Source: Yale University
• Contact: Andrew Jimenez, MD
• Phone: 813-295-3523
• Email: andrew.jimenez[@]yale.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: June 2053
• Est. primary completion date: June 2053
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoroacetabular Impingement
• Hip Arthroscopy

Intervention

Procedure:
• Hip Arthroscopy
Hip Preservation surgeries

Locations

Country	Name	City	State
United States	Yale New Haven Health	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Arthrex, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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