Five-Year Outcome of Ceramic on Ceramic Bearing Versus Ceramic on Crossfire® Highly Cross-Linked Polyethylene Bearing in Primary Total Hip Arthroplasty: A Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 3
- 主要终点
- WOMAC Function Score
研究概览
简要总结
Primary total hip arthroplasty (THA) has been a very successful surgical intervention in the geriatric population. Numerous studies have reported good mid and long term results of THA in patients over the age of 60 years. With the reported high success rate of this surgical intervention, the THA surgery is being performed in younger patients who have significant joint disease.
A clinical trial, using a randomized blinded design, was undertaken to compare the functional outcome of 1) alumina heads/alumina liners, and 2) alumina head/Crossfire polyethylene liners in patients 60 years of age or younger with non-inflammatory arthritis of the hip.
Subjects were assessed preoperatively and at one and five years postoperatively. Ten-year follow-up is currently underway.
The primary outcome measure is the WOMAC Osteoarthritis Index. Secondary measures were the RAND-12, as well as measurement of complication and revision rates. The patient's demand on the implant as calculated by the patient's age, weight, health status and activity level was also measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females scheduled for primary THA to treat non-inflammatory arthritis
- •Less than 61 years old at time of surgery
- •Able to speak and read the English language or have an available translator
- •Dorr Index A or B bone quality on preoperative radiographs
- •Willing and able to return for follow-up visits
排除标准
- •Have femoral or acetabular bone deficiency requiring augmentation
- •Ongoing corticosteroid use
- •Dorr Index C bone quality on the preoperative radiograph
- •Required a prosthesis neck length of greater than five millimeters
结局指标
主要结局
WOMAC Function Score
时间窗: Five years
This is a disease-specific patient reported outcome measure of function
Western Ontario McMaster Osteoarthritis Index (WOMAC) Pain Score
时间窗: Five Years
This is a disease-specific, patient reported outcome measure of pain.
WOMAC Stiffness Score
时间窗: Five Years
This is a disease-specific, patient-reported outcome measure of stiffness.
次要结局
- Revisions(Five Years)
- WOMAC Stiffness Score(10 years)
- Complications(10 years)
- RAND 12-Item Health Survey (RAND-12)(Five Years)
- WOMAC Pain Score(10 Years)
- WOMAC Function Score(One Year)
- RAND-12(10 years)
- Revision Rate(10 years)
- WOMAC Function Scores(10 years)