NCT02527148已完成不适用
A Prospective, Randomized, Controlled Trial of Mechanical Axis vs Kinematic Alignment in TKR - With a Follow-up, Longitudinal Study of the Clinical and Radiographic Outcomes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Oxford Knee Score
研究概览
简要总结
This is a prospective, randomized, longitudinal study of the clinical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement. In this study ShapeMatch® cutting guides will be compared to the conventional approach.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is a male or non-pregnant female between the ages of 40-80 years.
- •The patient requires a primary total knee replacement and is indicated for computer-assisted surgery.
- •Patient is deemed appropriate for a cruciate retaining knee replacement.
- •The patient has a primary diagnosis of osteoarthritis (OA).
- •The patient has intact collateral ligaments.
- •The patient is able to undergo MRI scanning of the affected limb.
- •The patient has signed the study specific, ethics-approved, Informed Consent document.
- •The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.
排除标准
- •The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.
- •Patient has had a previous osteotomy around the knee.
- •The patient is morbidly obese (BMI ≥ 40).
- •The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
- •The patient has a varus/valgus malalignment ≥ 15° (relative to mechanical axis).
- •The patient has a fixed flexion deformity ≥ 15°.
- •The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- •The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
- •The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
- •Patient has a cognitive impairment, an intellectual disability or a mental illness.
- •The patient is pregnant.
- •The patient has metal hardware present in the region of the hip, knee or ankle (as this is known to create geometrical distortion in the region of the implant).
- •The patient has any known contraindications for undergoing assessment by MRI (e.g. ferrous implants, metallic clips, magnetically activated implanted devices such as cardiac pacemakers, etc).
结局指标
主要结局
Oxford Knee Score
时间窗: Preoperatively, 6-week, 6-months, 12 months, 2 years and 5 years postoperatively
To demonstrate, through calculation of Oxford Knee Score (OKS) post operatively, that total knee replacement (TKR) performed using the ShapeMatch® Cutting Guide provides improvement from preoperative levels of patient pain and function comparable to the improvement obtained with TKR performed using computer-assisted Navigation. Oxford Knee Scores will be calculated pre-operatively and at 6 weeks, 6 months, 12 months, 2 years and 5 years. The OKS is a participant completed 12 question form on activities of daily living that assess function and pain. Scores can range from 0 to 48 with lower scores indicating a poor outcome and higher scores indicating a more satisfactory joint outcome.
次要结局
- Cost Effectiveness: Total Duration of Operating Procedure (Anaesthetic Time and Skin-to-skin Incision Time)(Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.)
- Cost Effectiveness: Length of Stay in Hospital(14 days)
- The Forgotten Joint Score (FJS-12)(6 week, 6 month, 12 month , 2 years and 5 years visits)
- Perth CT Protocol(3 months)
- Cost Effectiveness: Wound Length(Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.)
- Cost Effectiveness: Cost of Consumable Items Used During Operating Procedure(Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.)
- The Western Ontario and McMaster Universities Arthritis Index (WOMAC)(Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively)
- The International Knee Society Score (IKSS)(Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively)
- Cost Effectiveness: Quality-adjusted Life-years (QALYs) From EQ-5D-3L(12 months)
- Knee Pain(Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively)
- Health-related Quality of Life (EQ-5D-3L)(Preoperatively, 6-week, 6-month and 12 month visits, 2 years and 5 years)
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