Actively Recruiting

Phase 4
Age: 18Years - 60Years
All Genders
ID06500364

Knotless LoopLoc Device for Capsular Closure in Primary Hip Arthroscopy A Prospective Multi-Center Study for Femoro Acetabular Impingement

Led by American Hip Institute · Updated on 2025-01-01

80

Participants Needed

1

Research Sites

143 weeks

Total Duration

On this page

Sponsors

A

American Hip Institute

Lead Sponsor

A

Arthrex, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether the Arthrex LoopLocTM device offers better capsular closure during primary hip arthroscopy compared to other treatments. The hip capsule is the tissue that surrounds and supports the hip joint, which must be cut during surgery. Traditional repair methods use knotted sutures that may irritate surrounding tissues, potentially causing scar tissue and pain. The LoopLocTM device is knotless and may reduce irritation and scarring, possibly improving patient outcomes. The study is a prospective, multi-center Phase 4 trial comparing two groups of patients undergoing primary hip arthroscopy for femoro acetabular impingement. One group will have their hip capsule closed using the LoopLocTM device, while the control group will have closure without this device. Patients will be followed for two years after surgery to collect clinical and patient-reported outcomes. Participants will be closely monitored through follow-up visits over two years. Researchers will collect data on hip function using tools like the Modified Harris Hip Score to assess outcomes. Patients will be informed about the study and provide consent before participation. The study will analyze whether the LoopLocTM device leads to better outcomes than other closure methods in hip arthroscopy.

CONDITIONS

Official Title

Knotless Implants As an Alternative for Capsular Closure in Primary Hip Arthroscopy: a Prospective, Multi-Center Study

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

American Hip Institute Research Foundation

Des Plaines, Illinois, United States, 60018

Actively Recruiting

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Research Team

A

Alexandra Mantice

B

Benjamin Domb

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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Published Research Related To This Trial

Hip Capsular Repair Results in Improved Patient-Reported Outcomes and Survivorship: A Systematic Review of the Literature.

Andrew D Carbone, Omkar Prabhavalkar, Zayd Chishti...

https://pubmed.ncbi.nlm.nih.gov/36395962

A T-capsulotomy provides increased hip joint visualization compared with an extended interportal capsulotomy: commentary response.

Edward C Beck, Gregory L Cvetanovich, David M Levy...

https://pubmed.ncbi.nlm.nih.gov/31798933

Patient-Reported Outcomes of Capsular Repair Versus Capsulotomy in Patients Undergoing Hip Arthroscopy: Minimum 5-Year Follow-up-A Matched Comparison Study.

Benjamin G Domb, Edwin O Chaharbakhshi, Itay Perets...

https://pubmed.ncbi.nlm.nih.gov/29373289

Routine Capsular Closure With Hip Arthroscopic Surgery Results in Superior Outcomes: A Systematic Review and Meta-analysis.

Austin M Looney, Julia A McCann, Patrick T Connolly...

https://pubmed.ncbi.nlm.nih.gov/34403279

Periportal Capsulotomy: A Technique for Limited Violation of the Hip Capsule During Arthroscopy for Femoroacetabular Impingement.

Emily J Monroe, Caitlin C Chambers, Alan L Zhang

https://pubmed.ncbi.nlm.nih.gov/30906690

Should the Capsule Be Repaired or Plicated After Hip Arthroscopy for Labral Tears Associated With Femoroacetabular Impingement or Instability? A Systematic Review.

Victor Ortiz-Declet, Brian Mu, Austin W Chen...

https://pubmed.ncbi.nlm.nih.gov/28866345

Best practice guidelines for arthroscopic intervention in femoroacetabular impingement syndrome: results from an International Delphi Consensus Project-Phase 1.

Sarkhell Radha, Jonathan Hutt, Ajay Lall...

https://pubmed.ncbi.nlm.nih.gov/32015889
Knotless LoopLoc Device for Capsular Closure in Primary Hip Arthroscopy A Prospective Multi-Center Study for Femoro Acetabular Impingement | DecenTrialz