Absorbable vs Non-Absorbable Sutures for Hip Capsular Closure

NCT06845735 | Recruiting FDA Device

• 1 other identifier: 2099469
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

  Preoperative to 12 months postoperative

• 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.

  Preoperative to 12 months postoperative

• 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.

  Preoperative to 12 months postoperative

Secondary Outcomes (1)

• Rate of Radiographic Heterotrophic Ossification

  Evaluated at 6-months postoperatively

Study Arms (2)

Absorbable Suture

ACTIVE COMPARATOR

Absorbable suture

Device: Absorbable Suture

Non-Absorbable Suture

ACTIVE COMPARATOR

Non-Absorbable Sutures

Device: Non-Absorbable Sutures

Interventions

Non-Absorbable Sutures DEVICE

Non-Absorbable Sutures

Non-Absorbable Suture

Absorbable Suture DEVICE

Absorbable suture

Absorbable Suture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects 18 years of age and older.
• Subject requiring surgical hip arthroscopic intervention for their hip pathology

You may not qualify if:

• Subjects less than 18 years of age.
• Subjects with any other medical problem precluding anesthesia or surgery.
• Unable to provide informed consent.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

Missouri Orthopaedic Institute

Columbia, Missouri, 65201, United States

RECRUITING

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Vicki Jones, MEd, CCRP

CONTACT

573-882-7583; jonesvicki@health.missouri.edu

Trever T Simon

CONTACT

573-882-1403; t.simon@health.missouri.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Prof Orthopaedic surgery

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 25, 2025
• Study Start: March 22, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 4, 2025

Record last verified: 2025-04

Locations

US (1)