NCT01763684终止不适用
A Global Comparison of Signature Guides and Conventional Instrumentation in the Oxford Partial Knee
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 266
- 试验地点
- 14
- 主要终点
- Percentage of Knees Achieving Optimal Alignment
研究概览
简要总结
This study will compare alignment criteria in the Oxford Partial Knee using conventional instrumentation and Signature Custom Guides in order to determine if the use of the Signature Custom Guides results in a higher percentage of knees achieving optimal alignment. The study will also examine outcomes with high volume surgeons (>30 cases/year) and low volume surgeons (<10 cases/year).
详细描述
The primary objectives of this global clinical study are to collect data to assess the following clinical evidence parameters that were gathered from Biomet team members and KOL globally for this product:
- Evaluate the performance & accuracy of the Oxford Partial Knee System with Signature Knee Guide in comparison to conventional instrumentation.
- Compare the accuracy of Signature Guides between two user profiles: high volume surgeons & low volume surgeons in a global mix.
- Assess potential economic & efficiency advantages in the short term and long-term: OR efficiency, patient quality of life and activity, clinical outcomes.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intended for use in individuals with osteoarthritis or Avascular necrosis limited to the medial compartment of the knee that is also lacking patellofemoral or lateral compartment disease.
- •Use of cementless femoral fixation is permitted outside of the United States if it complies with all local, state, and/or national and international regulations. The same technique must be used consistently throughout the course of the study with all cases
- •Patients 21 and over
排除标准
- •Use of Cementless Fixation in the United States
- •Infection, sepsis or osteomyelitis
- •Use in lateral compartment of the knee
- •Rheumatoid arthritis or other forms of inflammatory joint disease
- •Revision of failed prosthesis, failed upper tibial osteotomy, or post traumatic arthritis after tibial plateau fracture
- •Insufficiency of the collateral, anterior, or posterior cruciate ligaments which would preclude stability of the device.
- •Disease or damage to the lateral compartment of the knee
- •Uncooperative patient or patient with neurologic disorders who is incapable of following directions
- •Osteoporosis in the United States / Insufficient bone stock outside the United States
- •Metabolic disorders which may impair bone formation
- •Osteomalacia
- •Distant foci of infections which may spread to implant site
- •Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
- •Vascular insufficiency, muscular atrophy, neuromuscular disease.
- •Incomplete or deficient soft tissue surrounding the knee.
- •Charcot's disease
- •A fixed varus deformity (not passively correctable) of greater than 15 degrees
- •A flexion deformity greater than 15 degrees.
- •Non-staged Bilateral patients
- •Patients who refuse, cannot, or should not receive a CT or MRI. Since patients are randomized into treatment groups, all patients must be able to receive an MRI (should follow local MRI screening protocol). This excludes patients who have metal artifacts in the knee, patients who are too large to fit into the knee coil, patients with pacemakers, patients unable to lie still for the duration of the MRI, and patients who are claustrophobic.
结局指标
主要结局
Percentage of Knees Achieving Optimal Alignment
时间窗: 12 weeks
Percentage of Knees Achieving Optimal Alignment defined as a difference of 5 or less between all target and observed angles.
次要结局
- Instruments Used During Surgery(Operative)
- Knee Society Objective Score(1 Year)
- Leg Alignment Tibial Varus/Valgus(Directly Postoperative)
- Leg Alignment Femoral Varus/Valgus(Directly Postoperative)
- Blood Loss(Right after surgery (up to 2 hours after surgery))
- Knee Society Functional Score(1 Year)
- Oxford Knee Score(1 Year)
- EQ5D Score(1 Year)
- Leg Alignment Femoral Flexion/Extension(Directly Postoperative)
- Leg Alignment Tibial Flexion/Extension(Directly Postoperative)
研究者
研究点 (14)
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