A Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data on the Exceed ABT Acetabular Cementless Cup System (Implants and Instruments)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 677
- 主要终点
- Harris Hip Score
研究概览
简要总结
A Post-market Clinical Follow-up Study to provide safety, performance and clinical benefits data on the Exceed ABT acetabular cup (implants and instruments) when used in combination with ceramic liners or polyethylene articulating liners bearing Options.
A single-center, cohort observational clinical outcomes study
详细描述
Study Aim: To collect survivorship and clinical outcomes long-term data confirm-ing safety, performance and clinical benefits of the Exceed ABT ce-mentless cup when used in combination with ceramic and polyeth-ylene articulating liners
Objectives: Primary Objectives:
Clinical performance - as measured by clinical score data (HHS, WOMAC and Oxford Hip Score), radiographic as-sessments and survivorship which will be based on removal of the device.
Secondary Objectives:
Safety will be evaluated by monitoring incidence of adverse events. Length of study: 13 years (3 years enrollment plus 10 years follow-up): Post-operative follow-up visits at: 1, 3, 5, 7 and 10 years
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are capable of understanding the doctor's explanations, following his instructions and are able to participate in the follow-up program
- •Patient who gave verbal consent to take part in the study at study commencement and written consent retrospectively at 10 years follow-up by signing the informed consent form according to the General data protection Regulation (GDPR) Patient Consent Form"
- •Age: => 18 years
- •Male and Female
- •Non- inflammatory degenerative joint disease including osteoarthritis, avascular necrosis & post traumatic arthritis
- •Rheumatoid arthritis,
- •Correction of functional deformity
- •Revision of failed joint reconstruction or treatment
- •Treatment of femoral neck and trochanteric fractures of the proximal femur with femoral head involvement and which are unmanageable using other techniques
排除标准
- •Infection, sepsis, and osteomyelitis
- •Patients who are unwilling or unable to give consent, or to comply with the follow-up program
- •The patient is known to be pregnant or breastfeeding
- •Any vulnerable subjects (= individuals whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate)
- •Uncooperative patient or patient with neurologic disorders who are incapable of fol-lowing instruction
- •Osteoporosis
- •Metabolic disorder which may impair bone formation
- •Osteomalacia
- •Local and distant foci of infection
- •Rapid joint destruction, marked bone loss or bone resorption apparent on roent-genogram
- •Vascular insufficiency, muscular atrophy, or neuromuscular disease
- •Skeletal immaturity
- •Morbid obesity
- •Foreign body sensitivity. Where suspected, material sensitivity tests are to be made prior to implantation
- •Any condition that may interfere with the survival of the implant such as Paget's disease, Charcot's disease, sickle cell anaemia or traits, lower extremity muscular atrophy or neuromuscular disease'
结局指标
主要结局
Harris Hip Score
时间窗: 10 years
Clinical performance - as measured by clinical score data (HHS). The HHS was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. The domains covered are pain, function, absence of deformity, and range of motion. The score has a minimum of 0 and a maximum of 100 points. The scale: Excellent:90 - 100, Good: 80 - 89, Fair: 70 - 79, Poor: \< 70.
10 Year Survivorship
时间窗: 10 years post-operative
Calculated Kaplan-Meier Survivorship based on revision of any component for any reason. Presented as the % of participants with the implant still in place 10 years post-operative.
Western Ontario and McMasters Universities Osteoarthritis Index-WOMAC Pain Score
时间窗: 10 years
Clinical performance - as measured by clinical score data - womac pain The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties The scores for each subscale are summed up, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function. A higher score indicates a worse clinical outcome. Womac pain score is reported here.
次要结局
- Oxford Hip Score(10 years)