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
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).
研究组 & 干预措施
OtisMed® ShapeMatch® with Triathlon
Participants randomised to the Intervention Group will undergo Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology with the goal of kinematic alignment (re-aligning the limb to its pre-disease kinematic alignment).
干预措施: OtisMed® ShapeMatch® Technology (Device)
OtisMed® ShapeMatch® with Triathlon
Participants randomised to the Intervention Group will undergo Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology with the goal of kinematic alignment (re-aligning the limb to its pre-disease kinematic alignment).
干预措施: Total Knee Replacement (Procedure)
OtisMed® ShapeMatch® with Triathlon
Participants randomised to the Intervention Group will undergo Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology with the goal of kinematic alignment (re-aligning the limb to its pre-disease kinematic alignment).
干预措施: Stryker Triathlon® Total Knee System (Device)
Stryker Precision Knee Navigation
Participants randomised to the Control Group will undergo Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation with the goal of neutral alignment to the mechanical axis. This is the standard method for TKR with Triathlon® Knee System and this group will serve as a control reference for the intervention group.
干预措施: Stryker Precision Knee Navigation (Device)
Stryker Precision Knee Navigation
Participants randomised to the Control Group will undergo Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation with the goal of neutral alignment to the mechanical axis. This is the standard method for TKR with Triathlon® Knee System and this group will serve as a control reference for the intervention group.
干预措施: Total Knee Replacement (Procedure)
Stryker Precision Knee Navigation
Participants randomised to the Control Group will undergo Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation with the goal of neutral alignment to the mechanical axis. This is the standard method for TKR with Triathlon® Knee System and this group will serve as a control reference for the intervention group.
干预措施: Stryker Triathlon® Total Knee System (Device)
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: 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: 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: 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)