Labrum Injury of the Hip Joint, Hip Arthroscopy, Femoroacetabular Impingement Syndrome
Conditions
Brief summary
The study is to prospectively compare absorbable sutures with non-absorbable sutures used for capsular repair during hip arthroscopic procedures. Major outcomes will be measured using three questionnaires ((1) International Hip Outcome Tool-12 (iHOT-12), (2) modified Harris hip score, (3) hip outcome score) in addition to the standard of care set of 9 questionnaires. The other major outcome will be any radiographic heterotrophic ossification at the 6-month follow-up time point.
Detailed description
1. International Hip Outcome Tool-12 is a 33-item patient-reported measure of health-related quality of life. It was designed to measure the impact of hip disease in young, active patients and to measure the effect of treatment of this disease. 2. Modified Harris hip score is composed of 8 survey questions to determine gait, functionality and pain. 3. The hip outcome score is 26 survey questions designed to asses the outcome of arthroscopic hip surgery for individuals with acetabular labral tears, including sports related questions and activities of daily living. Standard of care questionnaires will be given at follow up clinic visits. They are the: 1. Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function 2. PROMIS pain interference 3. PROMIS Global Health 4. Pain Visual Analog Scale 5. Hip Single Assessment Numeric Evaluation (SANE) 6. Modified Harris Hip Score 7. Marx Activity Scale 8. Tegner Activity Scale 9. Surgical Satisfaction These questionnaires will be given at preoperative, 6-week, 3-month, 6-month, 1 year, 2 years and any other follow-up visits in association with surgery. Any Radiographic images taken as standard of care (SOC) (post-operative radiographs are SOC) will be used in the study to determine Radiographic Heterotroph Ossification (HO) at 6 Months.
Interventions
DEVICENon-Absorbable Sutures
Non-Absorbable Sutures
DEVICEAbsorbable Suture
Absorbable suture
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects 18 years of age and older. * Subject requiring surgical hip arthroscopic intervention for their hip pathology
Exclusion criteria
* Subjects less than 18 years of age. * Subjects with any other medical problem precluding anesthesia or surgery. * Unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Hip Outcome Tool-12 (IHOT-12) | Preoperative to 12 months postoperative | 12-item patient-reported measure of health-related quality of life. It was designed to measure the impact of hip disease in young, active patients and to measure the effect of treatment of this disease. Each of the 12 questions assess hip function and are scored from 0-100. 0 is a low score and 100 is high score indicating excellent function. The IHOT-12 is scored from taking the average of the 12 items of the tool and is scored 0-100, 0 being a low score and poor function and 100 being a high score indicating excellent function. |
| Modified Harris Hip score | Preoperative to 12 months postoperative | composed of 8 survey questions to determine gait, functionality and pain. Each question is scored with a separate scoring range. Higher scores indicate better function and less pain. The score is calculated by adding up the assigned points for each item, dividing by the max score (91), and multiplying by 100 to create a percentage. A higher score indicates a higher level of physical function, with 100% indicating full function. |
| Hip Outcome Score (HOS) | Preoperative to 12 months postoperative | 28-item assessment that is divided into 2 subscales: activities of daily living (HOS-ADL;19 items) and sports-related activities (HOS-Sports;9 items). Of the 2 subscales, each question contains five answer choices ranging from low function (score of 0) to high function (score of 4). The maximum score possible for the HOS-ADL is 68. A high score indicates high function, and a low score indicates low function. The maximum score possible for the HOS-Sports is 36. A high score indicates high function, and a low score indicates low function. Scores for each subscale range from 0% (least function) to 100% (most function). Results can be interpreted with the following: \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Radiographic Heterotrophic Ossification | Evaluated at 6-months postoperatively | Any radiographic heterotrophic ossification at the 6-month follow-up time point. |
Countries
United States
Contacts
Primary ContactVicki Jones, MEd, CCRP
Backup ContactTrever T Simon
Outcome results
None listed