Knotless Implants As an Alternative for Capsular Closure in Primary Hip Arthroscopy: a Prospective, Multi-Center Study
NCT06500364 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2025-01-01
Summary
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.
Conditions
- Femoro Acetabular Impingement
Interventions
- DEVICE
-
LoopLoc Arm
Patients in this intervention will have had a capsular closure performed using a LoopLoc device after their hip arthroscopy.
- DEVICE
-
Control Arm
Patients in this intervention will have not had a capsular closure using a LoopLoc device after their hip arthroscopy.
Sponsors & Collaborators
-
Arthrex, Inc.
collaborator INDUSTRY -
American Hip Institute
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-29
- Primary Completion
- 2025-08-31
- Completion
- 2027-08-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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