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RecruitingNCT06845735Updated Aug 10, 2026

Absorbable vs Non-Absorbable Sutures for Hip Capsular Closure

An interventional study of Non-Absorbable Sutures and Absorbable Suture in Labrum Injury of the Hip Joint, Hip Arthroscopy and Femoroacetabular Impingement Syndrome, sponsored by University of Missouri-Columbia. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Labrum Injury of the Hip Joint
  • Hip Arthroscopy
  • Femoroacetabular Impingement Syndrome
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Subjects less than 18 years of age.
  • Subjects with any other medical problem precluding anesthesia or surgery.
  • Unable to provide informed consent.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Absorbable Suture

    Absorbable suture

    Device: Absorbable Suture

  • Active comparator
    Non-Absorbable Suture

    Non-Absorbable Sutures

    Device: Non-Absorbable Sutures

Interventions

  • DeviceNon-Absorbable Sutures

    Non-Absorbable Sutures

  • DeviceAbsorbable Suture

    Absorbable suture

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Preoperative to 12 months postoperative

  2. 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.

    Time frame: Preoperative to 12 months postoperative

  3. 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.

    Time frame: Preoperative to 12 months postoperative

Secondary outcomes

  1. Rate of Radiographic Heterotrophic Ossification

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

    Time frame: Evaluated at 6-months postoperatively

06

Study locations

1 of 1 sites recruiting
  • Missouri Orthopaedic Institute
    Columbia, Missouri 65201, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT06845735
Lead sponsor
University of Missouri-Columbia
Responsible party
Steven DeFroda (Asst Prof Orthopaedic surgery, University of Missouri-Columbia) — Principal investigator
First posted
Feb 25, 2025
Start date
Mar 22, 2024
Primary completion
Jan 1, 2028 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
Aug 10, 2026

Study contacts

Vicki Jones, MEd, CCRP
Contact
jonesvicki@health.missouri.edu
573-882-7583

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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