A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Secur-Fit Advanced Hip Stem
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 326
- 试验地点
- 15
- 主要终点
- Rate of Revision for Aseptic Loosening or Device-related Femoral Fracture
研究概览
简要总结
The goal of this study is to evaluate the Secur-Fit Advanced Hip Stem in primary total hip replacement surgery.
详细描述
This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Secur-Fit Advanced Hip Stem for primary total hip arthroplasty with a cementless application in a consecutive series of patients who meet the eligibility criteria.
The primary objective of this study is to evaluate the success rate of cementless primary total hip replacement with the Secur-Fit Advanced Hip Stem. Success will be defined as absence of femoral stem revision for aseptic loosening or device-related femoral fracture at 5 years postoperative. It is expected that the success rate of the Secur-Fit Advanced Hip Stem group will be non-inferior to the selected reference rate of 99% at 5 years postoperative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved, study specific Informed Patient Consent Form.
- •Patient is a male or non-pregnant female, skeletally mature and age 21-75 years at time of study device implantation.
- •Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease.
- •Patient is a candidate for primary total hip arthroplasty.
- •Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
排除标准
- •Patient has previously undergone open surgical intervention on the operative hip.
- •Patient has a prior femoral fracture, with or without deformity, on the operative side.
- •Patient has an existing total hip replacement on the contralateral side.
- •Patient requires simultaneous bilateral total hip replacement.
- •Patient has a Body Mass Index (BMI) >
- •Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
- •Patient has a neuromuscular or neurosensory deficiency that would create an unacceptable risk of instability, prosthesis fixation failure or complications in postoperative care, or which limits the ability to evaluate the safety and efficacy of the device.
- •Patient has bone stock that is inadequate for support or fixation of the prosthesis, or is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration.
- •Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
- •Patient has a known sensitivity to device materials.
- •Patient is a prisoner.
结局指标
主要结局
Rate of Revision for Aseptic Loosening or Device-related Femoral Fracture
时间窗: 5 years
The primary objective is to determine the success rate at 5 years postoperative with the Secur-Fit Advanced Hip Stem in the cementless application. Success is defined as absence of femoral stem revision and/or removal for aseptic loosening or device-related femoral fracture at 5 years postoperative.
次要结局
- All-cause Revision and Removal Rate(10 years)
- Rate of Device-related Femoral Fracture(30 days)
- Final Seating of Femoral Stem(Intraoperative)