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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new device called the Arthrex LoopLocTM, which may enhance how surgeons close the hip capsule (the tissue around the hip joint) after hip surgery. Researchers aim to determine if this knotless device reduces irritation and scar tissue compared to traditional methods. Participants will be divided into two groups: one using the new device and the other using standard methods. Candidates for the trial include those undergoing their first hip arthroscopy and planning to use this new device. As a Phase 4 trial, this study involves an FDA-approved device and seeks to understand its benefits for more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for the Arthrex LoopLocTM device?

Research has shown that the Arthrex LoopLocTM device is generally well-tolerated by patients undergoing hip surgery for femoroacetabular impingement, a condition where extra bone grows in the hip joint. Earlier studies found that patients whose hip capsules were repaired with knotless implants like the LoopLocTM experienced fewer issues, such as irritation or scar tissue, compared to those with traditional knotted stitches. This suggests that the LoopLocTM device may lead to better recovery with less discomfort after surgery. However, as with any medical device, individual experiences can differ, so discussing any concerns with a doctor before joining a clinical trial is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for femoroacetabular impingement, which often involves suturing techniques during hip arthroscopy, the LoopLoc device offers a knotless solution for closing the capsule. This innovative method reduces the complexity of the procedure and potentially minimizes recovery time by eliminating the need for knot tying. Researchers are excited about LoopLoc because it may lead to less postoperative pain and quicker rehabilitation, providing a smoother experience for patients compared to traditional methods.

What evidence suggests that the Arthrex LoopLocTM device is effective for capsular closure during hip arthroscopy?

Research has shown that using knotless implants, such as the Arthrex LoopLocTM device, for closing the hip capsule can improve outcomes after hip surgery. In this trial, participants in the LoopLoc Arm will receive the LoopLoc device following their hip arthroscopy. Studies have found that patients with these knotless devices experience less irritation and scar tissue compared to those with traditional knotted stitches. This can result in reduced pain and improved healing after surgery. Additionally, patients who show more improvement in the first year after hip surgery often achieve better long-term outcomes. Overall, the LoopLoc device may lead to a smoother recovery and enhanced long-term hip function. Participants in the Control Arm will undergo hip arthroscopy without the LoopLoc device. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

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

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

I have had hip surgery before.

My cartilage damage is severe.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40444746/

One-Year Outcomes Predict 10-Year Outcomes in Patients ...

Conclusion: Patients who experienced greater improvement in the first year after hip arthroscopy had superior 10-year outcome scores, fewer ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03077022

Femoroacetabular Impingement (FAI): The Effectiveness of ...

The investigators plan to prospectively collect data for three years and monitor the outcome of each hip patient, especially those treated with physical therapy ...

3.

bmcmusculoskeletdisord.biomedcentral.com

bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-025-08299-3

A meta-analysis of the effectiveness and side effects of hip ...

Five-year outcomes of primary hip arthroscopy for Femoroacetabular Impingement Syndrome among female patients: higher body Mass Index is ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12021968/

Long-term outcomes of arthroscopic management ...

Data from 478 patients showed significant improvements in PROMs from baseline to follow-up. Conclusion. This systematic review indicates that ...

5.

researchgate.net

researchgate.net/publication/370289300_Knotless_Implant_for_Arthroscopic_Hip_Capsule_Closure

(PDF) Knotless Implant for Arthroscopic Hip Capsule Closure

2. Treatment of avascular necrosis showed significantly poorer results than therapy of femoroacetabular impingement, hip labral tear and snapping hip syndrome ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10265480/

Knotless Implant for Arthroscopic Hip Capsule Closure - PMC

Capsular repair may improve outcomes in patients undergoing hip arthroscopy for femoroacetabular impingement: A systematic review of comparative outcome studies ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10587039/

Non-operative Management and Outcomes of ...

To serve as a guide for non-operative physicians in the management of femoroacetabular impingement syndrome and provide an algorithm as to ...

8.

hca.wa.gov

hca.wa.gov/assets/program/FAI-signals-search-update-2023.pdf

Safety and Efficacy of Femoroacetabular Impingement ...

One RCT reported that more arthroscopy patients compared with physical therapy patients achieved clinically important improvements in function ...