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

Обзор

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.

Подробное описание

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 Consent can be withdrawn at any time the participant chooses either verbally or in writing.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.

Вмешательства

• Устройство LoopLoc Arm
  Patients in this intervention will have had a capsular closure performed using a LoopLoc device after their hip arthroscopy.
• Устройство Control Arm
  Patients in this intervention will have not had a capsular closure using a LoopLoc device after their hip arthroscopy.

Первичные конечные точки

• Modified Harris Hip Score [Срок оценки: 2 years]

Вторичные конечные точки (5)

• Non-Arthritic Hip Score [Срок оценки: 2 years]
• International Hip Outcome Tool [Срок оценки: 2 years]
• Hip Outcome Score Sports-Specific Subscale [Срок оценки: 2 years]
• Visual Analog Scale [Срок оценки: 2 years]
• Patient Satisfaction [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• American Hip Institute Research Foundation — Des Plaines

Публикации

• 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. PMID 30611369
• 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. PMID 36395962
• 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. PMID 29349029
• 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. PMID 31798933
• 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. PMID 29373289
• 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. PMID 31891553
• 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. PMID 34403279
• 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. PMID 30906690

Идентификаторы

NCT: NCT06500364 · IIRR-01891

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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