Editorial Commentary: Acetabular Labral Repair-Is A Knotless Anchor Better?
F Alan Barber, J Richard Lee Evanson
https://pubmed.ncbi.nlm.nih.gov/30611369Actively Recruiting
Phase 4
Age: 18Years - 60Years
All Genders
ID06500364
Knotless Implants As an Alternative for Capsular Closure in Primary Hip Arthroscopy: a Prospective, Multi-Center Study
Led by American Hip Institute · Updated on 2025-01-01
80
Participants Needed
1
Research Sites
104 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 the Arthrex LoopLocTM device to see if it provides better capsular closure during hip arthroscopy compared to other treatments. The hip capsule is the tissue surrounding the hip joint that supports and stabilizes it, and it must be cut during hip arthroscopy. Traditional repair methods use knotted sutures that may cause irritation and scar tissue, potentially leading to pain. This study aims to compare outcomes between patients who receive the LoopLocTM device and those who do not after primary hip arthroscopy. Participants will either have the LoopLocTM device used for capsular closure during their hip arthroscopy or will undergo the procedure without this device as part of a control group. This prospective, multi-center study involves following patients for two years after surgery. Researchers will collect patient-reported and clinical outcomes to evaluate the feasibility and benefits of the knotless LoopLocTM device. During the two-year follow-up, patients will regularly visit their providers and researchers to assess outcomes such as the Modified Harris Hip Score, Non-Arthritic Hip Score, International Hip Outcome Tool, Hip Outcome Score Sports-Specific Subscale, Visual Analog Scale, and patient satisfaction. The study will monitor and compare these measures to determine if using the LoopLocTM device leads to improved results after hip arthroscopy.
CONDITIONS
Brief 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
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
You will not qualify if you...
- Patients that had previous hip surgery
- Patients with a center edge angle less than 25 degrees or greater than 40 degrees
- Patients with cartilage damage grade greater than or equal to 3
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - Day of surgery and immediate recovery period
Participants undergo primary hip arthroscopy with or without capsular closure using the LoopLoc device, followed by immediate post-operative care.
1 surgery visit and immediate post-operative care
Post-operative Follow-up
Duration - 2 years
Participants are followed up for two years with their providers and researchers who collect patient-reported and clinical outcomes.
Regular follow-up visits during 2 years
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
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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/36395962Puncture Capsulotomy During Hip Arthroscopy for Femoroacetabular Impingement: Preserving Anatomy and Biomechanics.
William K Conaway, Scott D Martin
https://pubmed.ncbi.nlm.nih.gov/29349029A 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/31798933Patient-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/29373289Prospective Randomized Comparison of Capsular Management Techniques During Hip Arthroscopy.
Kostas J Economopoulos, Anikar Chhabra, Christopher Kweon
https://pubmed.ncbi.nlm.nih.gov/31891553Routine 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/34403279Periportal 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/30906690Should 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/28866345Best 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