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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06500364
Enrollment
80
Registered
2024-07-15
Start date
2024-10-29
Completion date
2027-08-31
Last updated
2025-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoro Acetabular Impingement

Keywords

Hip arthroscopy, Hip capsule

Brief 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.

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.

Interventions

DEVICELoopLoc Arm

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

DEVICEControl Arm

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

Sponsors

Arthrex, Inc.
CollaboratorINDUSTRY
American Hip Institute
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Modified Harris Hip Score2 yearsPatient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.

Secondary

MeasureTime frameDescription
Non-Arthritic Hip Score2 yearsPatient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.
International Hip Outcome Tool2 yearsPatient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.
Hip Outcome Score Sports-Specific Subscale2 yearsPatient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome.
Visual Analog Scale2 yearsPatient-reported outcome measure. Scale 0-10, 10 indicating most amount of pain possible.
Patient Satisfaction2 yearsPatient-reported outcome measure. Scale 0-10, 10 indicating the highest level of satisfaction.

Countries

United States

Contacts

Primary ContactAlexandra Mantice
alexandra.mantice@americanhipinstitute.org8338724477
Backup ContactBenjamin Domb
drdomb@americanhipinstitute.org8338724477

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026