36mm CERAMAX® Ceramic Hip System PMA PAS STUDY: Short to Mid-Term Follow-up , New Study Subjects (Ceramic Hip System, Subjects Receive CERAMAX 36mm Ceramic Acetabular Bearing Insert That Articulates With a Ceramic Femoral Head for THA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 13
- 主要终点
- Post-Operative 5-Year Device Survivorship
研究概览
简要总结
This study is intended to gather short (Pre-operative to 4-years) and mid-term (5-years) information regarding the performance and safety of the commercially available 36mm CERAMAX® Ceramic on Ceramic Total Hip System from a cohort of new study subjects that were not previously involved in the IDE study for this device.
详细描述
Up to 10 (up to 5 original IDE + 5 new sites)
A prospective, non-controlled, non-randomized, multicenter study. Subjects will be seen for a clinic visit pre-operatively at the time of consent, (-90 days to surgery) and then at post-operatively at 6 weeks (1-92 days), 1 year (275-455 days), 2 years (640-820 days) and 3 years (1005-1185days), 4 years (1370-1550 days), and a minimum of 5 years (1825- 2555 days).
Data collected will include: Pre-operatively subject history and demographics; Operative and device details; and Post-operatively Harris HIp scores, Subject Hip Outcomes, and Adverse Events.
In order to optimize mid-term follow-up compliance, site personnel are permitted to contact the study subject in the 3 and 4 year intervals by phone (in place of a clinic visit) to assess the current status of the hip.
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
- •Males and females between 21 - 75 at the time of surgery.
- •Individuals, who in the opinion of the investigator, are suitable candidates for primary total hip replacement using the devices specified in this protocol.
- •Individuals with non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, and posttraumatic arthritis.
- •Individuals who are willing and able to provide informed patient consent for participation in the study;
- •Individuals who are willing and able to return for follow-up as specified by the study protocol; and
- •Individuals who are willing and able to complete the Subject Hip Outcomes questionnaire as specified by the study protocol.
排除标准
- •Skeletally immature patients (tibial and femoral epiphyses not closed)
- •Evidence of active infections that may spread to other areas of the body (e.g.,osteomyelitis, pyogenic infection of the hip joint, overt infection, urinary tract infection, etc.)
- •The presence of any known neoplastic (tumor-causing) or metastatic (spread of cancerous cells) disease
- •Significant neurologic or musculoskeletal disorders or diseases that may adversely affect gait, weight bearing or postoperative recovery (e.g., muscular dystrophy, multiple sclerosis)
- •Presence of highly communicable disease(s) that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.)
- •Any condition that may interfere with postoperative recovery (e.g., Paget's disease, Charcot's disease)
- •Inadequate bone stock to support the device (e.g., severe osteopenia orosteoporosis)
- •Poor skin coverage around the hip joint
- •Use in patients with known allergies to the implant materials
- •Marked atrophy (muscle and/or tissue loss) or deformity in the upper femur such as a birth defect affecting the leg bones.
- •Inflammatory degenerative joint disease (like rheumatoid arthritis)
- •Subject has participated in an IDE/IND clinical investigation, other than the COC28/COC36 IDE or PAS for their contralateral hip, with an investigational product in the last three months.
- •Subject is currently involved in a personal injury litigation, medical-legal or worker's compensation claims.
- •Subject is a known drug or alcohol abuser or has a psychological disorder that could affect their ability to comply with protocol procedures and/or subject-completed questionnaires.
- •The Subject is a woman who is pregnant or lactating.
- •The Subject has a medical condition with less than 2 years of life expectancy.
研究组 & 干预措施
CERAMAX COC 36mm Acetabular Cup
The CERAMAX 36mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic.The insert is available in several inner diameter sizes, including 36mm; only 36mm inserts will be utilized in this PAS. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper.
干预措施: COC 36mm (Device)
结局指标
主要结局
Post-Operative 5-Year Device Survivorship
时间窗: 5 years
Device survivorship at 5 years post-operatively was the primary endpoint in this study. A revision is defined as the removal of any Total Hip Arthroplasty (THA) component(s), and device survival is defined as the lack of revision. A 5-year Kaplan-Meier survivorship estimate of COC 36 mm implanted hips is provided.
次要结局
- Kaplan Meier Device Survivorship at Years 1 Through 6(Years 1 through 6 post-operatively)
- Annual Total Harris Hip Score(Annually through 5 years)
- Annual Harris Hip Pain Sub Score(Annually through 5 years)
- Annual Harris Hip Function and Activity Score(Annually through 5 years)
- Acetabular Cup Version - Annual Measurements(Measured from x-rays taken annually, years 1 through 5)
- Acetabular Cup Inclination(Measured from x-rays taken annually, years 1 through 5)
- Acetabular Cup Migration(Measured from x-rays taken annually, years 1 through 5)
- Heterotopic Ossification(Measured from x-rays taken annually, years 1 through 5)
- Acetabular Radiolucent Lines(Measured from x-rays taken annually, years 1 through 5)
- Acetabular Osteolysis(Measured from x-rays taken annually, years 1 through 5)
- Acetabular Sclerotic Lines(Measured from x-rays taken annually, years 1 though 5)
- Femoral Stem Position(Measured from x-rays taken annually, years 1 through 5)
- Femoral Stem Tilt(Measured from x-rays taken annually, years 1 through 5)
- Femoral Stem Subsidence(Measured from x-rays taken annually, years 1 through 5)
- Femoral Stem Heterotopic Ossification(Measured from x-rays taken annually, years 1 through 5)
- Femoral Radiolucent Lines(Measured from x-rays taken annually, years 1 through 5)
- Femoral Osteolysis(Measured from x-rays taken annually, years 1 through 5)
- Femoral Stem Sclerotic Lines(Measured from x-rays taken annually, years 1 through 5)
- Femoral Stem Calcar Resorption(Measure from x-rays taken annually, years 1 through 5)
- Femoral Stem Calcar Fracture(Measured from x-rays taken annually, years 1 through 5)