Knotless Implants for Femoroacetabular Impingement

Overseen By Alexandra Mantice

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: American Hip Institute

Disqualifiers: Previous hip surgery, CEA <25 or >40, Cartilage damage grade ≥3

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for patients under 60 years old undergoing their first hip arthroscopy, a type of minimally invasive surgery on the hip. Participants will have their hip capsule closed with the Arthrex LoopLocTM device after surgery.

Inclusion Criteria

I am scheduled for my first hip arthroscopy.

I am younger than 60 years old.

I will have my hip capsule closed with a specific device after surgery.

Exclusion Criteria

I have had hip surgery before.

Patients that had a center edge angle (CEA) less than 25 degrees or greater than 40 degrees

My cartilage damage is severe.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo hip arthroscopy with or without the LoopLocTM device for capsular closure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with outcomes measured over 2 years

2 years

Regular follow-up visits

Treatment Details

Interventions

• Control Arm
• LoopLoc Arm

Trial Overview The study is testing if using the knotless Arthrex LoopLocTM device for closing the hip capsule during surgery leads to better outcomes than traditional knotted sutures that may cause irritation and scar tissue.

Participant Groups

Group I: LoopLoc Arm Experimental Treatment 1 Intervention

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

Group II: Control Arm Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

American Hip Institute

Lead Sponsor

Trials

8

Recruited

470+

Arthrex, Inc.

Industry Sponsor

Trials

48

Recruited

30,200+