Knotless Implants As an Alternative for Capsular Closure in Primary Hip Arthroscopy: a Prospective, Multi-Center Study
NCT ID: NCT06500364
Last Updated: 2025-01-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
80 participants
INTERVENTIONAL
2024-10-29
2027-08-31
Brief Summary
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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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Detailed Description
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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 Consent can be withdrawn at any time the participant chooses either verbally or in writing.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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LoopLoc Arm
The patients in this group will have the LoopLoc device used following their hip arthroscopy, to close the capsule.
LoopLoc Arm
Patients in this intervention will have had a capsular closure performed using a LoopLoc device after their hip arthroscopy.
Control Arm
This is a control group, meaning they had their hip arthroscopy done without the use of the LoopLoc device.
Control Arm
Patients in this intervention will have not had a capsular closure using a LoopLoc device after their hip arthroscopy.
Interventions
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LoopLoc Arm
Patients in this intervention will have had a capsular closure performed using a LoopLoc device after their hip arthroscopy.
Control Arm
Patients in this intervention will have not had a capsular closure using a LoopLoc device after their hip arthroscopy.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
60 Years
ALL
No
Sponsors
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Arthrex, Inc.
INDUSTRY
American Hip Institute
OTHER
Responsible Party
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Locations
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American Hip Institute Research Foundation
Des Plaines, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Barber FA, Lee Evanson JR. Editorial Commentary: Acetabular Labral Repair-Is A Knotless Anchor Better? Arthroscopy. 2019 Jan;35(1):77-79. doi: 10.1016/j.arthro.2018.09.003.
Carbone AD, Prabhavalkar O, Chishti Z, Curley AJ, Parsa A, Domb BG. Hip Capsular Repair Results in Improved Patient-Reported Outcomes and Survivorship: A Systematic Review of the Literature. Arthroscopy. 2023 Feb;39(2):488-497. doi: 10.1016/j.arthro.2022.11.013. Epub 2022 Nov 14.
Conaway WK, Martin SD. Puncture Capsulotomy During Hip Arthroscopy for Femoroacetabular Impingement: Preserving Anatomy and Biomechanics. Arthrosc Tech. 2017 Nov 27;6(6):e2265-e2269. doi: 10.1016/j.eats.2017.08.036. eCollection 2017 Dec.
Beck EC, Cvetanovich GL, Levy DM, Weber AE, Kuhns BD, Khair MM, Rasio J, Nho SJ. A T-capsulotomy provides increased hip joint visualization compared with an extended interportal capsulotomy: commentary response. J Hip Preserv Surg. 2019 Nov 23;6(3):290-291. doi: 10.1093/jhps/hnz043. eCollection 2019 Aug. No abstract available.
Domb BG, Chaharbakhshi EO, Perets I, Walsh JP, Yuen LC, Ashberg LJ. Patient-Reported Outcomes of Capsular Repair Versus Capsulotomy in Patients Undergoing Hip Arthroscopy: Minimum 5-Year Follow-up-A Matched Comparison Study. Arthroscopy. 2018 Mar;34(3):853-863.e1. doi: 10.1016/j.arthro.2017.10.019. Epub 2018 Jan 17.
Economopoulos KJ, Chhabra A, Kweon C. Prospective Randomized Comparison of Capsular Management Techniques During Hip Arthroscopy. Am J Sports Med. 2020 Feb;48(2):395-402. doi: 10.1177/0363546519894301. Epub 2019 Dec 31.
Looney AM, McCann JA, Connolly PT, Comfort SM, Curley AJ, Postma WF. Routine Capsular Closure With Hip Arthroscopic Surgery Results in Superior Outcomes: A Systematic Review and Meta-analysis. Am J Sports Med. 2022 Jun;50(7):2007-2022. doi: 10.1177/03635465211023508. Epub 2021 Aug 17.
Monroe EJ, Chambers CC, Zhang AL. Periportal Capsulotomy: A Technique for Limited Violation of the Hip Capsule During Arthroscopy for Femoroacetabular Impingement. Arthrosc Tech. 2019 Jan 28;8(2):e205-e208. doi: 10.1016/j.eats.2018.10.015. eCollection 2019 Feb.
Ortiz-Declet V, Mu B, Chen AW, Litrenta J, Perets I, Yuen LC, Domb BG. Should the Capsule Be Repaired or Plicated After Hip Arthroscopy for Labral Tears Associated With Femoroacetabular Impingement or Instability? A Systematic Review. Arthroscopy. 2018 Jan;34(1):303-318. doi: 10.1016/j.arthro.2017.06.030. Epub 2017 Aug 31.
Radha S, Hutt J, Lall A, Domb B, Lynch TS, Griffin D, Field RE, Chuck-Cakic J. Best practice guidelines for arthroscopic intervention in femoroacetabular impingement syndrome: results from an International Delphi Consensus Project-Phase 1. J Hip Preserv Surg. 2019 Dec 16;6(4):326-338. doi: 10.1093/jhps/hnz055. eCollection 2019 Dec.
Willimon SC, Briggs KK, Philippon MJ. Intra-articular adhesions following hip arthroscopy: a risk factor analysis. Knee Surg Sports Traumatol Arthrosc. 2014 Apr;22(4):822-5. doi: 10.1007/s00167-013-2728-0. Epub 2013 Oct 26.
Other Identifiers
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IIRR-01891
Identifier Type: -
Identifier Source: org_study_id
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