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

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.

Study Overview

• Status: Recruiting
• Conditions: Hip Arthroscopy; Femoroacetabular Impingement Syndrome; Labrum Injury of the Hip Joint
• Intervention / Treatment: Device: Absorbable Suture; Device: Non-Absorbable Sutures

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vicki Jones, MEd, CCRP; Phone Number: 573-882-7583; Email: jonesvicki@health.missouri.edu
• Study Contact Backup: Name: Trever T Simon; Phone Number: 573-882-1403; Email: t.simon@health.missouri.edu

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Recruiting
      • Missouri Orthopaedic Institute
      • Contact: Vicki Jones, MEd, CCRP; Phone Number: 573-882-7583; Email: jonesvicki@health.missouri.edu
      • Principal Investigator: Steven F DeFroda, MD, MEng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Absorbable Suture; Absorbable suture	Device: Absorbable Suture; Absorbable suture
Active Comparator: Non-Absorbable Suture; Non-Absorbable Sutures	Device: Non-Absorbable Sutures; Non-Absorbable Sutures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Radiographic Heterotrophic Ossification	Any radiographic heterotrophic ossification at the 6-month follow-up time point.	Evaluated at 6-months postoperatively

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: January 27, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): February 25, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: May 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathologic Processes; Joint Diseases; Femoracetabular Impingement
• Other Study ID Numbers: 2099469

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes