A Prospective Clinical Data Collection of ArCom® and ArComXL® Polyethylene
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Osteoarthritis of Hip
- 发起方
- Zimmer Biomet
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Polyethylene wear rates
- 状态
- 已完成
- 最后更新
- 10个月前
概览
简要总结
The purpose of this prospective clinical data-collection is to document the performance, clinical outcomes, and wear rates of ArCom® and ArComXL® Polyethylene. The data gathered will be collated and used as a part of Biomet's post-market surveillance system and to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.
Inclusion/exclusion criteria are identical to those indications and contraindications stated in the FDA approved labeling for the device in 510(k) K926107 and 510(k) K043051. Surgical techniques and patient care are to be standard for the surgeons participating in the protocol.
详细描述
The study follow-up intervals are 6 weeks, 1 year, 2 years, 3 years, 5 years, and 10 years. Demographic data is collected pre-operatively along with the Harris Hip Score and UCLA Activity Score. Operative information includes the surgical technique and other standard operative information. Follow-up information includes the Harris Hip Score, UCLA Activity Score, and Radiographic data. Anterior/posterior and frog leg lateral X-ray data is recorded to show radiolucencies, component position and angles. Sites are also required to send in an Anterior/Posterior Pelvis x-ray for wear analysis. Implant durability is documented by asking the surgeon to record revisions, complications, and device related adverse events. All information collected is de-identified in compliance with HIPAA regulations.
研究者
入排标准
入选标准
- •Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- •Rheumatoid arthritis
- •Correction of functional deformity
- •Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
- •Revision of previously failed total hip arthroplasty
排除标准
- •Infection
- •Osteomyelitis
结局指标
主要结局
Polyethylene wear rates
时间窗: 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year
Independent wear analysis of radiographs. The six-week radiographic evaluation will be assessed in comparison to the one-year evaluation in order to determine the early changes of the polyethylene. The difference between the one and two-year evaluations will yield the first true wear rate. We have included a three-year evaluation to reduce the scatter of the linear regression used to calculate the wear rate. The five-year and ten-year evaluations will produce mid and long-term wear rates.
次要结局
- Pain, Function, Absence of Deformity, and Range of Motion(Pre-intervention, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year)
- Physical Activity Level(Surgery, 6 weeks, 1 year, 2 year, 3 year, 5 year, and 10 year)