Randomized Controlled Clinical Evaluation to Compare Vanguard Cruciate Retaining and AGC Total Condylar Knee Implants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- American Knee Society Knee Score
研究概览
简要总结
This evaluation is being conducted on the relative new knee system, the Vanguard Cruciate Retaining (CR) to evaluate clinical efficacy of the Vanguard CR components.
详细描述
This clinical trial was initially designed as a multi-centre, randomized controlled study, comparing the Vanguard CR with the AGC in routine use. The study now is a single centre study.
The Vanguard CR system has been specifically designed to give greater knee stability through the use of more anatomic patello-femoral kinematics.
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
- Single (Outcomes Assessor)
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
- •Pre-op knee score of <70
- •Scheduled to undergo primary total knee replacement with any of the following indication:
- •pain and disabled knee joint resulting from Osteoarthritis, Rheumatoid Arthritis, or Traumatic arthritis.
- •One or more compartments involved.
- •Need to obtain pain relief and improve function
- •Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations
- •A good nutritional state of the patient
- •Full skeletal maturity of the patient, patients who are at least 18 years of age.
- •Patients of either sex
- •Consent form read, understood, and signed by patient
排除标准
- •Pre-op knee score greater than or equal to 70
- •Infection
- •Osteomyelitis
- •Previous partial or total prosthetic knee replacement on the operative side
- •Skeletal immaturity of the patient, patients who are less than 18 years of age.
- •Uncooperative patient or patient with neurological disorders who are incapable of following directions
- •Osteomalacia
- •Distant foci of infections
- •Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
- •Vascular insufficiency, muscular atrophy, or neuromuscular disease in affected limb
- •Incomplete or deficient soft tissue surrounding the knee
研究组 & 干预措施
AGC knee
Patients were randomised to receive an AGC Cruciate Retaining cement knee. This is the control group in the study; the AGC is the gold standard of Biomets' knee products.
干预措施: AGC knee (Device)
Vanguard CR
Patients were randomised to receive a Vanguard Cruciate Retaining Knee from the Vanguard system which encompasses concepts used in the AGC family of knees. The Vanguard is specifically designed to give greater knees stability through use of more anatomic patello-femoral kinematics.
干预措施: Vanguard CR (Device)
结局指标
主要结局
American Knee Society Knee Score
时间窗: 2 year
Objective scoring system to rate the knee and patient's functional abilities before and after TKA
次要结局
- Survivorship(10 years)
- American Knee Society Score, Oxford Knee-12, SF-12(6w, 6m, 1y, 2y, 3y, 5y, 7y, 10y)
- Patient success(2 year)
- Noble & Weiss Knee Score, Kujala Score(6w, 6m, 1y, 2y)
- Radiographic evaluation(6m,1y, 2y, 3y, 5y, 10y)
- Adverse Events(any)