Modifications of Devices for Hip Arthroscopy

Обзор

This is protocol is intended to demonstrate the principal investigator's improvements and modifications of a hip capsule side fixed slotted cannula for continued access to the hip joint and a bone graft delivery tool set for grafting subchrondral cysts during hip arthroscopy procedure.

Подробное описание

Femoroacetabular impingement (FAI) and acetabular dysplasia represent the two most common causes of secondary osteoarthritis of the hip1-3 and the two main indications for Hip Preservation procedures. Most patients with these pathologies will undergo Hip Arthroscopy, either alone, or combined with bony realignment procedures. Hip arthroscopy has grown exponentially over the past 15 years and is currently being leveraged in the diagnosis and treatment of a wide range of hip joint problems.

In an effort to improve surgical techniques, make surgeries faster and reproducible, mitigate complications and increase patient safety, surgeons modify and improve commercially available and commonly used non-significant risk devices with the above goals in mind.

For these reasons, the Principal Investigator (PI) modified and improved two devices for hip arthroscopy. These include the modified (1) hip capsule side fixed slotted cannula for continued access to the hip joint and (2) bone graft delivery tool set for grafting subchrondral cysts arthroscopically during hip arthroscopy procedure. After utilizing these modified devices clinically, the PI has been impressed with their impact and thus aims to demonstrate that the modifications provide significant improvements in surgical flow and technique, minimize surgical time (per technical phase), minimize surgical costs, result in an absolute low incidence of surgical complications, and ultimately improve patient outcomes.

Вмешательства

• Устройство Modified hip capsule side fixed slotted cannula
  Modified hip capsule side fixed slotted cannula used during surgery to allow for continued access to the hip joint.
• Устройство Modified bone graft delivery tool set
  Modified bone graft delivery tool set for grafting subchrondral cysts arthroscopically during hip arthroscopy procedure.

Первичные конечные точки

• Surgical time per technical phase measured in minutes [Срок оценки: 1 Day]

Вторичные конечные точки (6)

• Rate of Surgical Complications [Срок оценки: Up to 24 months]
• Surgical costs per device used [Срок оценки: 1 Day]
• Patient Outcomes: Post-operative Pain [Срок оценки: Post operative up to Day 9]
• Patient Outcomes: Change in Pain [Срок оценки: Pre-treatment, Week 6, Month 3, Month 6, Month 12, Month 24]
• Patient Outcomes: Change in International Hip Outcome Tool (IHOT-12) Scores [Срок оценки: Pre-treatment, Week 6, Month 3, Month 6, Month 12, Month 24]
• Patient Outcomes: Change in Non-Arthritic Hip Scores [Срок оценки: Pre-treatment, Week 6, Month 3, Month 6, Month 12, Month 24]

Критерии участия

Критерии включения

• Males or females between the ages of 18 and 60 years diagnosed with FAI, Hip Dysplasia or the combination of the two.
• Persistent hip pain accompanied by mechanical symptoms refractory to nonoperative management lasting at least 3 months.
• Reproducible clinical examination findings suggestive of impingement and/or decreased range of motion, and positive radiographic findings on radiography, computed tomography with 3-dimensional reconstruction, and magnetic resonance imaging.
• Joint-space width > 3 mm on all views of plain radiography and 3-dimensional computed tomography.
• Patients undergoing hip arthroscopy for the treatment of FAI, Hip Dysplasia, or the combination of the two by the Principal Invesitgator.

Критерии исключения

• Age <18 years.
• Prisoners.
• Pregnant women.
• Decisionally challenged.
• Does not speak or understand English.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• University of Colorado, Hip Preservation Center, Orthopedic Department — Boulder
• UCHealth Steadman Hawkins Clinic - Denver — Englewood

Публикации

• Beck M, Kalhor M, Leunig M, Ganz R. Hip morphology influences the pattern of damage to the acetabular cartilage: femoroacetabular impingement as a cause of early osteoarthritis of the hip. J Bone Joint Surg Br. 2005 Jul;87(7):1012-8. doi: 10.1302/0301-620X.87B7.15203. PMID 15972923
• Zhang C, Li L, Forster BB, Kopec JA, Ratzlaff C, Halai L, Cibere J, Esdaile JM. Femoroacetabular impingement and osteoarthritis of the hip. Can Fam Physician. 2015 Dec;61(12):1055-60. PMID 26668284
• Lung R, O'Brien J, Grebenyuk J, Forster BB, De Vera M, Kopec J, Ratzlaff C, Garbuz D, Prlic H, Esdaile JM. The prevalence of radiographic femoroacetabular impingement in younger individuals undergoing total hip replacement for osteoarthritis. Clin Rheumatol. 2012 Aug;31(8):1239-42. doi: 10.1007/s10067-012-1981-9. Epub 2012 May 3. PMID 22552857
• Huo MH, Parvizi J, Bal BS, Mont MA; Council of Musculoskeletal Specialty Societies (COMSS) of the American Academy of Orthopaedic Surgeons. What's new in total hip arthroplasty. J Bone Joint Surg Am. 2008 Sep;90(9):2043-55. doi: 10.2106/JBJS.H.00741. No abstract available. PMID 18762667
• Kelly BT, Williams RJ 3rd, Philippon MJ. Hip arthroscopy: current indications, treatment options, and management issues. Am J Sports Med. 2003 Nov-Dec;31(6):1020-37. doi: 10.1177/03635465030310060701. PMID 14623676
• Philippon MJ, Stubbs AJ, Schenker ML, Maxwell RB, Ganz R, Leunig M. Arthroscopic management of femoroacetabular impingement: osteoplasty technique and literature review. Am J Sports Med. 2007 Sep;35(9):1571-80. doi: 10.1177/0363546507300258. Epub 2007 Apr 9. PMID 17420508
• Huo MH, Parvizi J, Bal BS, Mont MA. What's new in total hip arthroplasty. J Bone Joint Surg Am. 2009 Oct;91(10):2522-34. doi: 10.2106/JBJS.I.00801. No abstract available. PMID 19797590
• Leunig M, Werlen S, Ungersbock A, Ito K, Ganz R. Evaluation of the acetabular labrum by MR arthrography. J Bone Joint Surg Br. 1997 Mar;79(2):230-4. doi: 10.1302/0301-620x.79b2.7288. PMID 9119848

Идентификаторы

NCT: NCT04516109 · 19-2755

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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