Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology

Официальное название

Periacetabular Osteotomy With and Without Arthroscopic Management of Central Compartment Pathology: A Multicenter Randomized Controlled Trial

Обзор

At present, it is not clear whether performing a hip arthroscopy at the same time as a PAO improves patient outcomes after surgery compared to a PAO alone. This research project will randomize patients to receive either a PAO alone, or a PAO and a hip arthroscopy at the same time.

Подробное описание

Hip dysplasia is a developmental abnormality of the acetabulum (hip socket) that causes abnormal stresses inside the hip joint and leads to painful arthritis at a young age. Many patients develop painful symptoms in their hip before advanced arthritis occurs.

The periacetabular osteotomy (PAO) is a surgical procedure that reorients the acetabulum to reduce the stresses inside the hip joint. The PAO is very effective at improving symptoms and quality of life. However, some patients may have residual symptoms.

Frequently, people with hip dysplasia will have an MRI done before their surgery, which helps to identify other the abnormalities inside their hip joint (e.g., labral tears). These abnormalities inside the joint cannot easily be addressed through PAO alone, however they can be addressed with hip arthroscopy. Hip arthroscopy is a separate minimally invasive surgical procedure that allows the surgeon to access the inside of the hip joint with a small camera and address any abnormalities.

At present, it is not clear whether performing a hip arthroscopy at the same time as a PAO improves patient outcomes after surgery compared to a PAO alone.

This research project will randomize patients to receive either a PAO alone, or a PAO and a hip arthroscopy at the same time. Patients will be followed for 2 years after surgery. Symptomatic differences between the two patient groups will be assessed to determine added benefit of the hip arthroscopy.

Вмешательства

• Процедура PAO with hip arthroscopy
  Participants who are randomized to the Scope-PAO group will receive central compartment hip arthroscopy in addition to the PAO.
• Процедура PAO without hip arthroscopy
  Participants who are randomized to the "PAO-only" group will receive a Bernese Periacetabular Osteotomy (PAO) for treatment of hip dysplasia.

Первичные конечные точки

• iHOT-33 [Срок оценки: 24 months]

Вторичные конечные точки (6)

• HOOS [Срок оценки: before surgery, 6 months, 12 months, 24 months after surgery]
• PROMIS Global 10 [Срок оценки: before surgery, 6 months, 12 months, 24 months after surgery]
• Operative time [Срок оценки: intra-operative]
• Hospital Length of Stay [Срок оценки: up to one month]
• Adverse Events [Срок оценки: 2-4 weeks and 3 months after surgery]
• Cost-Effectiveness [Срок оценки: 6 months, 12 months, and 24 months after surgery]

Критерии участия

Критерии включения

• Skeletally mature patient undergoing Bernese periacetabular osteotomy for symptomatic acetabular dysplasia/hip instability
• Pre-Operative MRI at 3T and/or gadolinium MR arthrogram
• Age, 16-50 years old
• Patient capable of giving informed consent

Критерии исключения

• Prior hip/pelvis surgery of any kind on the surgical side
• Prior hip arthroplasty surgery on either side
• Radiographic evidence of arthritis (i.e. Tönnis grade =2)
• Known connective tissue disorder (e.g. Ehlers-Danlos Syndrome, etc.)
• Known neuromuscular disorder (e.g. Cerebral Palsy, Spina bifida, etc.)
• Known skeletal dysplasia (e.g. Achondroplasia, Multiple Epiphyseal Dysplasia, etc.)
• Cognitive impairment that prevents accurate completion of patient-reported outcome questionnaires.
• Patient unable/unwilling to complete all required follow-up visits
• Concurrent proximal femoral osteotomy and/or surgical hip dislocation

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 4 центра

• Northwestern University — Chicago
• William Beaumont Hospital — Royal Oak
• The Washington University — St Louis
• Hospital for Special Surgery — New York

Канада · 3 центра

• Children's Hospital of Eastern Ontario — Ottawa
• Ottawa Hospital Research Institute — Ottawa
• CHU de Québec - Université Laval — Québec

Публикации

• Beaule PE, Verhaegen JCF, Clohisy JC, Zaltz I, Stover MD, Belzile EL, Sink EL, Carsen S, Nepple JJ, Smit KM, Wilkin GP, Poitras S. The Otto Aufranc Award: Does Hip Arthroscopy at the Time of Periacetabular Osteotomy Improve the Clinical Outcome for the Treatment of Hip Dysplasia? A Multicenter Randomized Clinical Trial. J Arthroplasty. 2024 Sep;39(9 Suppl 1):S9-S16. doi: 10.1016/j.arth.2024.05.035 PMID 38768770
• Wilkin GP, Poitras S, Clohisy J, Belzile E, Zaltz I, Grammatopoulos G, Melkus G, Rakhra K, Ramsay T, Thavorn K, Beaule PE. Periacetabular osteotomy with or without arthroscopic management in patients with hip dysplasia: study protocol for a multicenter randomized controlled trial. Trials. 2020 Aug 18;21(1):725. doi: 10.1186/s13063-020-04592-9. PMID 32811527

Идентификаторы

NCT: NCT03481010 · 20170796

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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