Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-01 @ 2:38 PM
Study NCT ID:
NCT06845735
Status:
RECRUITING
Last Update Posted:
2025-05-04
First Post:
2025-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Absorbable vs Non-Absorbable Sutures for Hip Capsular Closure
Sponsor:
University of Missouri-Columbia
Organization:
Study Overview
Official Title:
Prospective Randomized Control Trial Comparing Absorbable Sutures to Non-Absorbable Sutures for Capsular Closures in Hip Arthroscopies
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: