Prospective Post Market Clinical Follow-Up Study of the Continuum Metal on Polyethylene Acetabular System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 4
- 主要终点
- Survivorship
研究概览
简要总结
This is a prospective, multi-center, non-randomized, non-controlled study designed to obtain survival and outcome data on the Continuum Metal on Polyethylene Acetabular System when used in primary total hip arthroplasty.
详细描述
The safety and performance of the Continuum Metal on Polyethylene Acetabular System will be confirmed by the assessment of survival and outcome data. Assessments will include standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility, and survivorship of the Continuum Metal on Polyethylene Acetabular system in primary total hip arthroplasty. Metal ion (cobalt, chromium and titanium) and renal function (BUN, Creatinine and GFR) levels will be analyzed for a subset of the enrolled study subjects.
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 (simultaneous or staged) total hip arthroplasty (THA) based on physical exam and medical history including the following:
- •Avascular necrosis (AVN)
- •Osteoarthritis
- •Inflammatory arthritis (i.e., Rheumatoid arthritis)
- •Post-traumatic arthritis
- •Patient has no history of previous prosthetic replacement device of any type, including surface replacement arthroplasty, endoprosthesis, etc. of the affected hip joint(s).
- •Patient has moderate, marked or disabling pain.
- •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 IRB 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 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 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 affected 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 and/or cysts in the operative hip.
- •The patient has a Body Mass Index (BMI) > 40.
研究组 & 干预措施
Continuum Acetabular System
Patients receiving primary hip arthroplasty using the Continuum Metal on Polyethylene Acetabular System
干预措施: Continuum Metal on Polyethylene Acetabular System (Device)
结局指标
主要结局
Survivorship
时间窗: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Based on removal or intended removal of the device and determined using the Kaplan-Meier method.
Safety / Adverse Events
时间窗: Surgery, 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Safety will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects.
次要结局
- Pain and Function / OHS(6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year)
- Health Status / Radiographic Parameters(6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year)
- Pain and Function / HHS(6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year)
- Health Status / SF-12(6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year)