About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
LoopLoc Arm
DevicePatients in this intervention will have had a capsular closure performed using a LoopLoc device after their hip arthroscopy.
Control Arm
DevicePatients in this intervention will have not had a capsular closure using a LoopLoc device after their hip arthroscopy.
Treatment groups
Trial outcomes
Primary outcomes
Modified Harris Hip Score
Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.
Secondary outcomes
Non-Arthritic Hip Score
Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.
International Hip Outcome Tool
Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.
Hip Outcome Score Sports-Specific Subscale
Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.
Visual Analog Scale
Patient-reported outcome measure. Scale 0-10, 10 indicating most amount of pain possible.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
American Hip Institute
Lead sponsor
Arthrex, Inc.
Collaborator