The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Composite clinical success (CCS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The patients, clinical assessors and data analysts will be blinded to the intervention each patient has received for the 24 month post-operative period. The surgeon, operating theatre team, radiographic analysts and CRO cannot be blinded but will not be involved in the care of the patient after the intervention unless the patient requires revision surgery.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
The H1 Implant
Cementless, ceramic-on-ceramic hip resurfacing arthroplasty (HRA) device.
干预措施: The H1 Implant (Device)
Cementless total hip replacement
Cementless ceramic-on-poly or ceramic-on-ceramic total hip replacement
干预措施: Cementless total hip replacement (Device)
结局指标
主要结局
Composite clinical success (CCS)
时间窗: 24 months post-operatively
The primary outcome is "composite clinical success". This is a binary outcome measure. Patients are deemed to have achieved CCS if they meet all of the following criteria at the 24 month timepoint: * Modified Harris Hip Score ≥80. * No revision or pending revision. * Acetabular radiolucencies: not in all zones. * Femoral radiolucencies: not in all zones. * Absence of subsidence/migration of the acetabular or femoral component \>5mm with clinical findings. * Absence of specific adverse device effects (ADEs) that are pre-cursors to revision of the device, namely: * Bone breakage around the implanted component(s) (periprosthetic fracture). * Breakage of the device component. * Device movement/migration of clinical consequence as defined by associated clinical findings as: a limp; leg length discrepancy; and restricted range of motion. * Dislocation of the hip joint.
次要结局
- Noise(6 weeks, 6 months, 12 months and 24 months post-operatively)
- Physical Activity(Pre-operatively, 6 months, 12 months and 24 months post-operatively)