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)
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Non-inflammatory Degenerative Joint Disease
- 发起方
- DePuy Orthopaedics
- 入组人数
- 172
- 试验地点
- 13
- 主要终点
- Post-Operative 5-Year Device Survivorship
- 状态
- 已完成
- 最后更新
- 9个月前
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.
研究者
入排标准
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.
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)