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NCT Number: NCT06500364

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

American Hip Institute Research Foundation

Des Plaines, Illinois, 60018, United States

Location status: Recruiting

Location contact

Alexandra Mantice

CONTACT

[email protected]

8472829808

About this study

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 Consent can be withdrawn at any time the participant chooses either verbally or in writing.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LoopLoc Arm

Device

Patients in this intervention will have had a capsular closure performed using a LoopLoc device after their hip arthroscopy.

Control arm

Device

Patients in this intervention will have not had a capsular closure using a LoopLoc device after their hip arthroscopy.

Primary outcomes

  1. Modified Harris Hip Score

    Time frame: 2 years

    Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.

Secondary outcomes

  1. Non-Arthritic Hip Score

    Time frame: 2 years

    Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.

  2. International Hip Outcome Tool

    Time frame: 2 years

    Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.

  3. Hip Outcome Score Sports-Specific Subscale

    Time frame: 2 years

    Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.

  4. Visual Analog Scale

    Time frame: 2 years

    Patient-reported outcome measure. Scale 0-10, 10 indicating most amount of pain possible.

  5. Patient Satisfaction

    Time frame: 2 years

    Patient-reported outcome measure. Scale 0-10, 10 indicating the highest level of satisfaction.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Mantice

CONTACT

[email protected]

8338724477

Benjamin Domb

CONTACT

[email protected]

8338724477

Sponsors and collaborators

Lead sponsor

American Hip Institute

Other

Collaborators

  • Arthrex, Inc.

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Jul 15, 2024
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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