Alloclassic® Variall® Cup Ceramic Bearing System in Total Hip Arthroplasty A Multi-center, Prospective, Non-controlled Post Market Surveillance Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Clinical Success Will be Based on the Harris Hip Scoring System
研究概览
简要总结
The study is a multicenter, prospective, non-randomized, non-controlled consecutive cohort post-market clinical follow-up study.
详细描述
The objectives of this study are to obtain survival and outcomes data on the Alloclassic® Variall® Cup in combination with the BIOLOX® delta Taper Liner and a BIOLOX® delta Femoral Head used in primary total hip arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records.
Two sites are involved in this study, enrolling a total of 100 patients for the study. All subjects were required to participate in the Informed Consent Process.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is skeletally mature.
- •Patient qualifies for primary unilateral or bilateral total hip arthroplasty (THA) based on physical exam and medical history including the following:
- •Avascular necrosis (AVN)
- •Osteoarthritis (OA)
- •Inflammatory arthritis
- •Post-traumatic arthritis
- •Patient has no history of previous prosthetic replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) of the affected hip joint(s).
- •Patient has a Harris Hip Score <70 in the affected hip
- •Patient is willing and able to provide written informed consent.
- •Patient is willing and able to cooperate in the required post-operative therapy.
- •Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
- •Patient has participated in the Informed Consent process and has signed the Ethics Committee approved informed consent.
排除标准
- •The patient is:
- •A prisoner
- •Mentally incompetent or unable to understand what participation in the study entails
- •A known alcohol or drug abuser
- •Anticipated to be non-compliant.
- •The patient has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- •The patient has a neurologic condition in the ipsilateral or contralateral limb which affects lower limb function.
- •The patient has a known history of systemic disease that could affect his/her safety or the study outcome.
- •The patient is known to be pregnant.
- •The patient is unwilling or unable to give informed consent, or to comply with the follow-up program.
- •The patient is not having any other investigational drug or device simultaneously.
- •The patient has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously.
- •The patient has insufficient bone stock to fix the component. Insufficient bone stock exists in the presence of metabolic bone disease (i.e. clinical relevant osteoporosis), cancer, and radiation. Note: Dual Energy X-ray Absorptiometry (DEXA) may be used to assess the presence of adequate bone stock.
- •The patient has osteoradionecrosis in the operative hip joint
- •The patient has a known sensitivity or allergic reaction to one or more of the implanted materials.
- •The patient has known local bone tumors in the operative hip.
- •The patient is Grade III obese with a Body Mass Inldex (BMI) > 40.
结局指标
主要结局
Clinical Success Will be Based on the Harris Hip Scoring System
时间窗: 3 years
The Harris Hip Score (HHS) was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The score has a minimum of 0 points and a maximum of 100 points. Clinical success will be defined as a modified Harris Hip score of \> 80 that included a rating of 'mild', or 'no pain'; a failure will be defined as a modified Harris Hip score \< 80.
Percentage of Participants Who Survived According to the Survival Analysis With the Kaplan Meier (K-M) Estimate
时间窗: 4 years
Endpoint revision of any investigational device for any reason attributable to any investigational device
次要结局
- Oxford Hip Score(3 years)
- EQ-5D(3 years)