Continuum™ Metal 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
- 83
- 试验地点
- 3
- 主要终点
- Implant Survival at 10 Years
研究概览
简要总结
The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and outcome data on the Continuum Metal Bearing System in primary total hip arthroplasty.
详细描述
The subject of this clinical investigation is the Continuum Metal Bearing THA System in primary total hip arthroplasty. This system consists of a cementless modular Trabecular Metal® (TM) Continuum Acetabular Shell, a modular Metasul Taper liner, and a modular Metasul femoral head. The characteristics of this THA system may allow for reduction in wear and osteolysis as compared to other approved and marketed THA systems and thus increase the expected implant life.
In total, 3 sites were involved. This number of clinical sites permitted assessment of the consistency among a multitude of investigators. A total number of 83 were included in the study.
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 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 known local bone tumors and/or cysts in the operative hip.
- •The patient has a known allergic reaction to one or more of the implanted material.
- •The patient is Grade III obese with a Body Mass Index (BMI) ≥
- •The patient has osteoradionecrosis in the affected hip joint
- •Kidney insufficiency (Kidney insufficiency will be determined based on eGFR value.
- •See Blood Analysis Report CRF for details)
结局指标
主要结局
Implant Survival at 10 Years
时间窗: 1, 2, 3, 5, 7, and 10 years postop.
The primary endpoint for this study is implant survival at 10 years which was assessed by revision either of the Continuum Cup or the Metasul liner. A success rate for the experimental group was calculated using the Kaplan-Meier Survival Estimation.
次要结局
- The Harris Hip Score (HHS)(Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op)
- The Subject Quality-of-Life (SF-12): Physical and Mental Socres(Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op)
- Radiographic Evaluations(Immediate-postop, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op.)
- Metal Ion Concentration in Blood(Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op.)
- EQ5D(Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op)
- Creatine Concentration and BUN(Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op.)
- Calculated GFR(Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op.)