Absorbable vs Non-Absorbable Sutures for Hip Capsular Closure

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06845735
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Missouri-Columbia
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Labrum Injury of the Hip Joint, Hip Arthroscopy, Femoroacetabular Impingement Syndrome
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Absorbable Suture

Absorbable suture

Active Comparator: Non-Absorbable Suture

Non-Absorbable Sutures

Interventions

Device: - Non-Absorbable Sutures

Non-Absorbable Sutures

Device: - Absorbable Suture

Absorbable suture

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Missouri Orthopaedic Institute, Columbia, Missouri

Status

Recruiting

Address

Missouri Orthopaedic Institute

Columbia, Missouri, 65201

Site Contact

Vicki Jones, MEd, CCRP

[email protected]

573-882-7583