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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.
Standard of care questionnaires will be given at follow up clinic visits. They are the:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Absorbable Suture | Active Comparator | Absorbable suture |
|
| Non-Absorbable Suture | Active Comparator | Non-Absorbable Sutures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Absorbable Sutures | Device | Non-Absorbable Sutures |
| |
| Measure | Description | Time Frame |
|---|---|---|
| International Hip Outcome Tool-12 (IHOT-12) | 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. | Preoperative to 12 months postoperative |
| Modified Harris Hip score | 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. | Preoperative to 12 months postoperative |
| Hip Outcome Score (HOS) | 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. | Preoperative to 12 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Radiographic Heterotrophic Ossification | Any radiographic heterotrophic ossification at the 6-month follow-up time point. | Evaluated at 6-months postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vicki Jones, MEd, CCRP | Contact | 573-882-7583 | jonesvicki@health.missouri.edu | |
| Trever T Simon | Contact | 573-882-1403 | t.simon@health.missouri.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Missouri Orthopaedic Institute | Recruiting | Columbia | Missouri | 65201 | United States |
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| ID | Term |
|---|---|
| D057925 | Femoracetabular Impingement |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Absorbable Suture |
| Device |
Absorbable suture |
|