An Evaluation of Hip Preservation Outcomes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorYale University
About this trial
The purpose of this study is to assess outcomes of hip preservation surgeries including open and arthroscopic treatment of femoroacetabular impingement (FAI).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Candidates for surgical intervention of the hip
Participant and/or guardian has given informed consent and assent as applicable.
Disqualifiers
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
Trial population
Patients age 12 years and older who are candidates for surgical intervention of the hip.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Hip Arthroscopy
Procedure/SurgeryHip Preservation surgeries
Treatment groups
10,000 Participants
are divided into 1 treatment groupGroup A: Participants Undergoing Hip Preservation/Surgical Interventions1 intervention
Trial outcomes
Primary outcomes
1
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.
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-operatively2
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.
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-operatively3
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.
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-operatively4
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.
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-operativelySecondary outcomes
1
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.
Time frame
3 months, 6 months, 1 year, 2 year, 5 year and 10 year2
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.
Time frame
up to 10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
Arthrex, Inc.
Collaborator
Source ClinicalTrials.gov