Recruiting

Knotless Implants

Sponsor:

American Hip Institute

Code:

NCT06500364

Conditions

Femoro Acetabular Impingement

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

LoopLoc Arm

Control Arm

Study Details

Brief summary:

The purpose of this research is to see if the Arthrex LoopLocTM device is better for capsular closure during hip arthroscopy than other treatments available.

The hip capsule is the tissue that surrounds your hip joint. It stabilizes and supports your hip joint. During hip arthroscopy, this tissue must be cut through in order to perform the hip arthroscopy. Once the hip arthroscopy is completed, the surgeon might repair the capsule. Current ways of repairing the capsule include knotted suture that might irritate structures around the hip, leading to the possible formation of scar tissue and pain. The Arthrex LoopLocTM device is knotless and may lower the presence of irritation and scar tissue around the hip after surgery and might lead to better outcomes.

Therefore, researchers will compare patients who had the LoopLocTM device used to close their hip capsule during surgery to those who did not have the device used, to see if there is a difference in their outcomes following surgery.

Conditions

Femoro Acetabular Impingement

Study ID

NCT06500364

Start date

Oct 29, 2024

Status verified date

Dec, 2024

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients undergoing a primary hip arthroscopy
  • Patients younger than 60 years old.
  • Patients who will receive capsular closure with the Arthrex LoopLocTM device following hip arthroscopy.

Exclusion Criteria:

  • Patients that had previous hip surgery,
  • Patients that had a center edge angle (CEA) less than 25 degrees or greater than 40 degrees.
  • Patients that have a cartilage damage grade greater than or equal to 3.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LoopLoc Arm

The patients in this group will have the LoopLoc device used following their hip arthroscopy, to close the capsule.

active comparator: Control Arm

This is a control group, meaning they had their hip arthroscopy done without the use of the LoopLoc device.

Interventions

LoopLoc Arm

Patients in this intervention will have had a capsular closure performed using a LoopLoc device after their hip arthroscopy.

Control Arm

Patients in this intervention will have not had a capsular closure using a LoopLoc device after their hip arthroscopy.

Primary outcome measure

  • Modified Harris Hip Score [ Time Frame: 2 years ]

Central Contacts and Locations

Locations

American Hip Institute Research Foundation

Recruiting

Des Plaines, Illinois, United States, 60018

Contacts

More Information

Sponsor

American Hip Institute

Last update posted

Jan 1, 2025

Last verified

Dec, 2024

Keywords

  • Hip arthroscopy
  • Hip capsule

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by American Hip Institute on 2025-01-01.