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

Part of paid clinical trials in Des Plaines, Illinois.

Sponsor
American Hip Institute
Study ID
NCT06500364
Phase
PHASE4
Status
Recruiting
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Conditions

  • Femoro Acetabular Impingement

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Oct 29, 2024
Status verified
Dec 2024
Primary completion
Aug 31, 2025
Completion
Aug 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LoopLoc Arm
    The patients in this group will have the LoopLoc device used following their hip arthroscopy, to close the capsule.
  • Active Comparator: Control Arm
    This is a control group, meaning they had their hip arthroscopy done without the use of the LoopLoc device.

Primary Outcome Measure

Modified Harris Hip Score [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
American Hip Institute Research FoundationDes PlainesIllinois60018
Alexandra Mantice
[email protected]
8472829808

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By research site
American Hip Institute Research Foundation· Des Plaines, IL

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