Allofit® IT 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
- 已完成
- 入组人数
- 185
- 试验地点
- 4
- 主要终点
- Survivorship
研究概览
简要总结
This is a multi-center, prospective, non-controlled post market surveillance study. The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty.
详细描述
The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty.
This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility and survivorship, and to confirm the safety and performance of the Allofit IT Ceramic Bearing System.
A total of 200 patients are planned to be enrolled in this study which will last 12 years (2 year enrollment plus 10 years follow-up) with the follow-up visits at 6 months, 1, 2, 3, 5, 7, and 10 years post-operatively.
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 18 to 75 years of age, inclusive.
- •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 (i.e. Rheumatoid 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 vascular (large and small vessel disease) insufficiency.
- •The patient has a neurologic condition in the ipsalateral or contralateral limb which affects lower limb function.
- •The patient has a diagnosed 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 has received an investigational drug or device within the previous 6 months.
- •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. 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 Index (BMI) > 40.
结局指标
主要结局
Survivorship
时间窗: 10 years post-surgery
The objective of this study is implant survival at 10 years which is assessed by revision of the the study device calculated using the Kaplan-Meier Survival Estimation. The survivorship with Kaplan-Meier (K-M) was calculated at 10 year for endpoint revision of any component.
Safety of the Implant
时间窗: Up to 10 years postoperative
Will be evaluated by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE) b) Efficacy:
次要结局
- Harris Hip Score(pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year)
- EQ-5D(pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year)
- SF-12 Physical and Mental Functional Scores(pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year)
- UCLA Activity Score(pre-op, 6 Months, 1 Year, 2 Year, 3 Year, 5 Year, 7 Year, 10 Year)
- Radiographic Evaluations(10 Years post-surgery)