A Comparison of Total Hip Arthroplasty and Hip Preservation Outcomes
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hip Arthroscopy
- Sponsor
- Yale University
- Enrollment
- 10000
- Locations
- 1
- Primary Endpoint
- Change in Hip Outcome Score (HOS)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Secondary Outcomes
- 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)