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NCT Number: NCT06845735

Absorbable vs Non-Absorbable Sutures for Hip Capsular Closure

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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Key information

Conditions

Labrum Injury of the Hip Joint Femoracetabular Impingement Femoroacetabular Impingement Syndrome Hip Arthroscopy Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Missouri Orthopaedic Institute

Columbia, Missouri, 65201, United States

Location status: Recruiting

Location contact

Steven F DeFroda, MD, MEng

PRINCIPAL_INVESTIGATOR

Vicki Jones, MEd, CCRP

CONTACT

[email protected]

573-882-7583

About this study

  • 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.
  • Modified Harris hip score is composed of 8 survey questions to determine gait, functionality and pain.
  • 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:

  • Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function
  • PROMIS pain interference
  • PROMIS Global Health
  • Pain Visual Analog Scale
  • Hip Single Assessment Numeric Evaluation (SANE)
  • Modified Harris Hip Score
  • Marx Activity Scale
  • Tegner Activity Scale
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-Absorbable Sutures

Device

Non-Absorbable Sutures

Absorbable Suture

Device

Absorbable suture

Primary outcomes

  1. International Hip Outcome Tool-12 (IHOT-12)

    Time frame: Preoperative to 12 months postoperative

    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.

  2. Modified Harris Hip score

    Time frame: Preoperative to 12 months postoperative

    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.

  3. Hip Outcome Score (HOS)

    Time frame: Preoperative to 12 months postoperative

    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.

Secondary outcomes

  1. Rate of Radiographic Heterotrophic Ossification

    Time frame: Evaluated at 6-months postoperatively

    Any radiographic heterotrophic ossification at the 6-month follow-up time point.

Study contacts

Contact information is provided by the study sponsor or research team.

Trever T Simon

CONTACT

[email protected]

573-882-1403

Vicki Jones, MEd, CCRP

CONTACT

[email protected]

573-882-7583

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 25, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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