Clinical Outcome Following Total Hip Arthroplasty With the SMF Stem A Prospective, Consecutive Series, Multi-center Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 126
- 试验地点
- 6
- 主要终点
- Revision of the study device
研究概览
简要总结
This is a prospective, consecutive series, multicenter clinical study of clinical outcomes following total hip arthroplasty with the SMF stem.
详细描述
The objectives of this study are to evaluate the safety and efficacy of the study device. This study will document any device-related, surgical or post-operative complication and adverse radiographic observations. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems. Outcome measures will be quantified through statistical analysis of study device , HOOS questionnaire, radiographic assessments, Harris Hip Score, and adverse event reports.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 presents with non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, avascular necrosis, rheumatoid arthritis of or any of it's composite diagnosis.
- •Patient is of legal age to consent, is skeletally mature and at least 18 years old.
- •Patient is willing to consent to participate in the study by signing and dating an IRB-approved consent form.
- •Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological or other conditions that would pose excessive operative risk.
排除标准
- •Patient has poor bone stock and would make the procedure unjustifiable: A) patients which are under medical care for osteoporosis (taking hormones, Calcitonin or biphosphates) or for other metabolic pathologies, which could influence the quality of the bone (for example hyperparathyroidism, hyperthyreoidismus and osteomalacie) will be excluded from the study. B) patients suffering from Morbus Paget (osteodystrophia deformans) will be excluded from the study.
- •Patient has conditions that tend to place increased loads on implants such as weight, chargot joint, muscular deficiencies and activity level, which are incompatible with a satisfactory long-term result: A) patients with a BMI > 40 will be excluded from the study B) patients participating in high-impact sports like baseball, basketball, football, handball, hockey, karate, racquet-ball, running, soccer, water skiing or similar impact sports will be excluded from the study.
- •Patient is over the age of
- •Skeletal immaturity: patients must be at least 18 years at the time of the operation.
- •Patient has an active, local infection that would lead to increased bone resorption.
- •Mental or neurological conditions that tend to pre-empt the patient's ability or willingness to restrict activities.
- •Known sensitivity to materials of the implant.
- •Patient is pregnant or plans to be come pregnant during the course of the study.
- •Patient is a prisoner.
结局指标
主要结局
Revision of the study device
时间窗: Discharge through 10 years
Instances of required revision of the study device
Device related Adverse Events
时间窗: Implant through 10 years
surgical, device-related, death and serious adverse events will be analyzed
Harris Hip Score
时间窗: Baseline through 10 years
Questionnaire to calculate pain, walking abilities, activities, degrees of hip motion
HOOS Questionnaire
时间窗: Baseline through 10 years
Questionnaire to calculate hip symptoms, stiffness, pain, function and quality of life
次要结局
未报告次要终点