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Recruiting NCT06845735

Absorbable vs Non-Absorbable Sutures for Hip Capsular Closure

No phase Interventional Labrum Injury of the Hip Joint Hip Arthroscopy Femoroacetabular Impingement Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-Absorbable Sutures, Absorbable Suture.
Who it may be relevant to
Registry conditions: Labrum Injury of the Hip Joint, Hip Arthroscopy, Femoroacetabular Impingement Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • Device Non-Absorbable Sutures
    Non-Absorbable Sutures
  • Device Absorbable Suture
    Absorbable suture

Primary outcome measures

  • International Hip Outcome Tool-12 (IHOT-12) [Time frame: Preoperative to 12 months postoperative]
  • Modified Harris Hip score [Time frame: Preoperative to 12 months postoperative]
  • Hip Outcome Score (HOS) [Time frame: Preoperative to 12 months postoperative]
Secondary outcome measures (1)
  • Rate of Radiographic Heterotrophic Ossification [Time frame: Evaluated at 6-months postoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Missouri Orthopaedic Institute — Columbia

Identifiers

NCT: NCT06845735 · 2099469

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗