NCT06845735

Absorbable vs Non-Absorbable Sutures for Hip Capsular Closure

Prospective Randomized Control Trial Comparing Absorbable Sutures to Non-Absorbable Sutures for Capsular Closures in Hip Arthroscopies

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Labrum Injury of the Hip Joint
• Hip Arthroscopy
• Femoroacetabular Impingement Syndrome

Interventions

Type	Name	Description
DEVICE	Non-Absorbable Sutures	Non-Absorbable Sutures
DEVICE	Absorbable Suture	Absorbable suture

Timeline

• Start date: 2024-03-22
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2025-02-25
• Last updated: 2025-05-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study