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

December 30, 2024 updated by: American Hip Institute

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of the study is to perform a prospective multi-center study evaluating the feasibility of a knotless capsular closure device in patients undergoing primary hip arthroscopy.

All patients that meet study inclusion and exclusion criteria will then be informed about the study and given the IRB-approved consent form. All patients will learn about the study during a clinic visit and will have the opportunity to review the consent form and ask questions. All questions and concerns about study participation and the consent form will be addressed by staff and staff will ensure patient understanding of the consent form. The study participant will then sign and date the consent form, as well as the research staff obtaining consent. Consent can be withdrawn at any time the participant chooses either verbally or in writing.

Patients will be indicated by their physician for a capsular closuring using the LoopLocTM device. These patients will follow up for two years with their providers and researchers, who will collect their patient-reported and clinical outcomes. Data from this study will be analyzed to determine if the LoopLocTM device for capsular closure has better outcomes than the alternative treatments available.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LoopLoc Arm
The patients in this group will have the LoopLoc device used following their hip arthroscopy, to close the capsule.
Device: LoopLoc Arm
Patients in this intervention will have had a capsular closure performed using a LoopLoc device after their hip arthroscopy.
Active Comparator: Control Arm
This is a control group, meaning they had their hip arthroscopy done without the use of the LoopLoc device.
Device: Control Arm
Patients in this intervention will have not had a capsular closure using a LoopLoc device after their hip arthroscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Harris Hip Score
Time Frame: 2 years
Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-Arthritic Hip Score
Time Frame: 2 years
Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.
2 years
International Hip Outcome Tool
Time Frame: 2 years
Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.
2 years
Hip Outcome Score Sports-Specific Subscale
Time Frame: 2 years
Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.
2 years
Visual Analog Scale
Time Frame: 2 years
Patient-reported outcome measure. Scale 0-10, 10 indicating most amount of pain possible.
2 years
Patient Satisfaction
Time Frame: 2 years
Patient-reported outcome measure. Scale 0-10, 10 indicating the highest level of satisfaction.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Hip Institute

Collaborators

Arthrex, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 30, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIRR-01891

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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