Retrospective and Prospective Post-Market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Zimmer® Maxera™ Cup (Implants and Instrumentation)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
研究概览
简要总结
This study is monocentric, retrospective and prospective, non-controlled, consecutive series Post-Market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Largest Zimmer® Maxera™ Cup (Implants and Instrumentation)
详细描述
The Zimmer Maxera Cup is a monoblock construct that consists of a preassembled shell and liner. The ceramic liner articulates with a ceramic femoral head for a ceramic-on-ceramic large diameter head articulation.
The BIOLOX® delta ceramic liner (insert) is preassembled to lock into the tapered shell's cavity and articulate with BIOLOX OPTION ceramic femoral heads, sizes 32, 36, 40, 44, and 48 mm and standard BIOLOX delta ceramic femoral head sizes 32, 36, and 40 mm.
This is a single center post-market clinical evaluation. A consecutive series of 32 patients treated with a Maxera Cup (outer diameter 64 mm or 66 mm) between Nov 2011 and Feb 2018 will be identified and invited to participate in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient received a Maxera Cup with an outer diameter of 64 mm or 66 mm.
- •The Zimmer Maxera Cup is indicated for non-cemented use in skeletally mature individuals undergoing primary surgery for rehabilitating hips damaged as a result of non-inflammatory degenerative joint disease (NIDJD) including but not limited to osteoarthritis, avascular necrosis, post-traumatic arthritis, congenital hip dysplasia, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis if bone quality is adequate.
排除标准
- •Active, old, or remote infection of the hip.
- •Osteoradionecrosis.
- •Local bone tumors and/or cysts.
- •Patients with poor bone quality, where there is inadequate bone to support the implant(s).
- •Neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation.
- •Allergy to the implanted material.
- •Patient's physical conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriately sized implant, e.g. previous surgery, insufficient quality or quantity of bone resulting from conditions such as cancer or congenital dislocation, metabolic bone disease of the upper femur or pelvis, femoral osteotomy revision, girdle stone revision, osteoporosis, osteomyelitis, neuromuscular compromise or vascular deficiency in the affected limb in sufficient degree to render the procedure unjustifiable (e.g. absence of musculoligamentous supporting structures, joint neuropathy) or other conditions that may lead to inadequate skeletal fixation
- •Do not use ceramic femoral heads which are not BIOLOX delta or BIOLOX OPTION with Maxera components.
- •Use of this device when a less invasive procedure would be sufficient.
- •Skeletal immaturity.
- •Any nerve or muscle disease that may have a negative effect on gait or weight bearing
- •Loss of abductor musculature in the affected limb.
- •Poor skin coverage around the hip joint.
- •Rapid disease progression as obvious by joint destruction or bone absorption seen on x-ray.
结局指标
主要结局
Implant survival based on removal or intended removal of the device and determined using the Kaplan-Meier method
时间窗: 10 years post-surgery
次要结局
- X-rays evaluated for radiolucencies, osteolysis, hypertrophy, subsidence, heterotopic ossification, etc(10 years post-surgery)
- Pain and functional performance based on the Harris Hip Score(10 years post-surgery)
- Subject quality-of-life determined by the EQ-5D (EuroQoI) score(10 years post-surgery)
- Safety based on eventual complications occurred including dislocations and revisions/removals(10 years post-surgery)