The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement

Обзор

The goal of this randomised controlled trial is to compare the success of two types of hip replacement in patients with hip arthritis. The main question it aims to answer is whether a new type of hip replacement (called a hip resurfacing) can be as successful as an existing hip replacement (called a total hip replacement). Patients will be given either the new hip resurfacing or the existing total hip replacement and researchers will compare their function, complication rate and physical activity.

Подробное описание

The H1 Implant is a cementless, ceramic hip resurfacing arthroplasty (HRA) device. The intended purpose of the H1 Implant is to provide an artificial substitute for a disease-damaged hip joint to replace the articulating surfaces of the hip while preserving the underlying femoral head and natural femoral neck. This is standard for a resurfacing hip prosthesis. This study will randomise patients to receive either The H1 Implant or a primary cementless ceramic-on-poly or ceramic-on-ceramic total hip replacement (THR). Composite clinical success (CCS) scores, physical activity levels and patient reported outcome measures (PROMs) will be compared for the two groups. The primary objective of the study is to determine whether the H1 Implant is non-inferior to cementless THR in terms of CCS. The key secondary objective is to determine whether the H1 Implant is superior compared to cementless THR in terms of physical activity and PROMs. Other secondary objectives are to compare the H1 Implant and THR with respect to: safety, through collection of all device-related, operative site-related and systemic adverse events; and noise generation, through patient survey.

Вмешательства

• Устройство The H1 Implant
  Patients allocated to The H1 Implant arm will be implanted with the H1 Implant which is a cementless, ceramic hip resurfacing device.
• Устройство Cementless total hip replacement
  Patients allocated to cementless total hip replacement arm will be implanted with a cementless ceramic-on-poly or ceramic-on-ceramic total hip replacement

Первичные конечные точки

• Composite clinical success (CCS) [Срок оценки: 24 months post-operatively]

Вторичные конечные точки (5)

• Physical Activity [Срок оценки: 6 months, 12 months and 24 months post-operatively]
• Physical Activity [Срок оценки: Pre-operatively, 6 months, 12 months and 24 months post-operatively]
• Physical Activity [Срок оценки: Pre-operatively, 6 months, 12 months and 24 months post-operatively]
• Physical Activity [Срок оценки: Pre-operatively, 6 months, 12 months and 24 months post-operatively]
• Noise [Срок оценки: 6 weeks, 6 months, 12 months and 24 months post-operatively]

Критерии участия

Критерии включения

• Patient requires unilateral primary hip arthroplasty due to primary osteoarthritis, osteoarthritis secondary to e.g. trauma, avascular necrosis or developmental hip dysplasia, or inflammatory arthritis.
• Patient is willing to comply with study requirements.
• Patient plans to be available through 10 years postoperative follow-up.

Критерии исключения

• Patient has a BMI greater than 40 kg/m².
• Patient has active infection or sepsis (treated or untreated).
• Patient has insufficient bone stock at the hip (>1/3 necrosis of the femoral head or large and multiple cysts) or in general as in severe osteopenia or osteoporosis (t-score < -2.5 as measured with BMD).
• Patient is not skeletally mature.
• Patient meets the contraindication criteria of the control device.
• Patient already has another lower limb arthroplasty or arthrodesis or will require a further lower limb arthroplasty or arthrodesis within the subsequent 2 years.
• Patient lacks capacity to consent.
• Patient is unable to understand the native language of the country where their procedure is taking place

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06162195 · 327954

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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