Clinical trial NCT06845735: Absorbable vs Non-Absorbable Sutures for Hip Capsular Closure
Official title: Prospective Randomized Control Trial Comparing Absorbable Sutures to Non-Absorbable Sutures for Capsular Closures in Hip Arthroscopies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Labrum Injury of the Hip Joint
Hip Arthroscopy
Femoroacetabular Impingement Syndrome
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: International Hip Outcome Tool-12 (IHOT-12)
timeFrame: Preoperative to 12 months postoperative
measure: Modified Harris Hip score
timeFrame: Preoperative to 12 months postoperative
measure: Hip Outcome Score (HOS)
timeFrame: Preoperative to 12 months postoperative
Secondary outcomes:
measure: Rate of Radiographic Heterotrophic Ossification
timeFrame: Evaluated at 6-months postoperatively
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Missouri Orthopaedic Institute
state: Missouri
Study officials:
References: