Absorbable vs Non-Absorbable Sutures for Hip Capsular Closure

University of Missouri (MU)

Status: Enrolling

Conditions: Labrum Injury of the Hip Joint; Femoroacetabular Impingement Syndrome; Hip Arthroscopy

Treatments: Device: Absorbable Suture; Device: Non-Absorbable Sutures

Study type: Interventional

Funder types: Other

Identifiers

NCT06845735

2099469

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Absorbable Suture

Active Comparator group

Description:

Absorbable suture

Treatment:

Device: Absorbable Suture

Non-Absorbable Suture

Active Comparator group

Description:

Non-Absorbable Sutures

Treatment:

Device: Non-Absorbable Sutures