Absorbable vs Non-Absorbable Sutures for Hip Capsular Closure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Missouri-Columbia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects 18 years of age and older.
Subject requiring surgical hip arthroscopic intervention for their hip pathology
Disqualifiers
Subjects less than 18 years of age.
Subjects with any other medical problem precluding anesthesia or surgery.
Unable to provide informed consent.
Trial design
Design model
Parallel
Treatments tested in this trial
Non-Absorbable Sutures
DeviceNon-Absorbable Sutures
Absorbable Suture
DeviceAbsorbable suture
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Absorbable SutureActive comparator 1 intervention
Group B: Non-Absorbable SutureActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Preoperative to 12 months postoperative2
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.
Time frame
Preoperative to 12 months postoperative3
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.
Time frame
Preoperative to 12 months postoperativeSecondary outcomes
1
Rate of Radiographic Heterotrophic Ossification
Any radiographic heterotrophic ossification at the 6-month follow-up time point.
Time frame
Evaluated at 6-months postoperativelySponsors and contacts
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Source ClinicalTrials.gov