Absorbable vs Non-Absorbable Sutures for Hip Capsular Closure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-22

Study Completion Date

2028-01-01

Brief Summary

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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.

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Detailed Description

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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

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Labrum Injury of the Hip Joint Hip Arthroscopy Femoroacetabular Impingement Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Absorbable Suture

Absorbable suture

Group Type ACTIVE_COMPARATOR

Absorbable Suture

Intervention Type DEVICE

Absorbable suture

Non-Absorbable Suture

Non-Absorbable Sutures

Group Type ACTIVE_COMPARATOR

Non-Absorbable Sutures

Intervention Type DEVICE

Non-Absorbable Sutures

Interventions

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Non-Absorbable Sutures

Intervention Type DEVICE

Absorbable Suture

Absorbable suture

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No