LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study - An Open Label, Prospective, Post-market, Multi-center Clinical Evaluation of the LFIT™ Anatomic CoCr Femoral Heads With X3® Inserts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 10
- 主要终点
- Linear Wear Rate
研究概览
简要总结
Total hip replacement surgery is considered to be a very successful surgical procedure for the treatment of degenerative joint disease. The purpose of the study is to evaluate a large size (36mm, 40mm or 44mm) femoral (hip) head called the LFIT™ Anatomic CoCr Femoral Head (Low Friction Ion Treatment). The large size femoral heads will be used with the Trident® X3® polyethylene (plastic) inserts and will be compared with a historical control. Study Hypothesis: The linear wear rate for hips implanted with the LFIT™ Anatomic CoCr Femoral Head is no worse than 0.08 mm wear per year at 5 years post-surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is candidate for a primary cementless total hip replacement, and a posterolateral surgical approach is planned.
- •Patient's preoperative templating predicts the use of a Hemispherical Acetabular Shell size 52mm or larger.
- •Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). Patient must have diagnosis of osteoarthritis (OA), traumatic arthritis (TA), avascular necrosis (AVN), slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation, or diastrophic variant
- •Patient is a male or non-pregnant female age 18 years or older at time of enrollment.
- •Patient has signed an IRB approved, study specific Informed Patient Consent Form.
- •Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
排除标准
- •Patient has an active infection within the affected hip joint.
- •Patient requires revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
- •Patient has a Body Mass Index (BMI) ≥
- •Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
- •Patient is diagnosed with systemic disease or current life threatening illness and is not able to carry on normal activities of daily life (i.e. Paget's disease, renal osteodystrophy, rheumatoid arthritis).
- •Patient is immunologically suppressed or receiving chronic steroids in excess of 5mg per day.
- •Patient has a recent history of substance dependency that may result in deviations from the evaluation schedule.
- •Patient is a prisoner.
研究组 & 干预措施
LFIT™Femoral Heads With X3® Insert
LFIT™ Femoral Heads With X3® Insert
干预措施: LFIT™ Femoral Heads With X3® Insert (Device)
结局指标
主要结局
Linear Wear Rate
时间窗: 5 Years Post-Surgery
Linear wear rate is defined as the annual rate of removal of the polyethylene from the X3 polyethylene insert mated with LFIT™ Anatomic CoCr Femoral Heads determined by comparing digitized images of serial radiographs obtained over the follow-up period. .
次要结局
- Change in Harris Hip Score (HHS) Range of Motion (ROM) Score From Pre-operative to Post-operative Visits.(preoperative, 1, 3, and 5 Years)
- Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals.(preop, 1, 3, and 5 Years)
- Change in Harris Hip Score (HHS) Pain Score From Pre-operative to Post-operative Visits(preop, 1, 3, and 5 Years)
- Number of Hips That Dislocated(3 and 5 years)
- Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative(preoperative, 1, 3, and 5 Years)
- Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits(preoperative, 1, 3, and 5 years)
- Percentage of Cases That Did Not Have Any Component Revised(5 years)
- Number of Hips Evaluated as Radiographically Unstable(1, 3, 5 years)