Randomized Controlled Trial of Sensor Guided Knee Balancing Compared to Standard Balancing Technique in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Rate of Unbalanced TKRs
研究概览
简要总结
To ensure a successful outcome after total knee replacement (TKR) soft tissue balance and proper implant position are very important during the surgical procedure. Soft tissues are structures in the knee including ligaments, muscles, tendons, and menisci that stabilize and cushion the knee joint. Lack of proper soft tissue balance or imprecise implant positioning may result in knee stiffness, pain, instability and limited range of motion (ROM). This may result in implant failure and the need for revision surgery. As part of standard practice orthopedic surgeons use a manual knee balancer device to help guide soft tissue balancing to achieve optimal knee balance. New sensor-assisted technology can provide surgeons with measurable information to help achieve soft tissue balancing, providing surgeons with immediate visual feedback during the surgery. This feedback, transmitted wirelessly by the sensor, gives surgeons electronic information on soft tissue balance and implant position.The purpose of this study is to determine if a sensor guided soft tissue balancing device (Verasense) is more effective at balancing the knee during surgery as compared to standard soft tissue balancing performed with a manual balancer device.
详细描述
The study is that of a prospective double-blind randomized controlled trial of patients presenting for elective primary TKR to compare the outcomes of TKR using conventional soft tissue balancing with a tensiometer device versus augmenting the soft tissue balancing with the OrthoSensor VerasenseTM sensor device. The primary outcome will be rate of unbalanced TKRs based on the quantitative Verasense definition of a well balanced knee defined as a mediolateral intercompartmental loading difference of ≤15 pounds through ROM. Secondary outcomes include differences in clinical outcome scores and patient satisfaction among sensor guided cases and controls.
Patients will be randomized to receive TKR with the Triathlon total knee system (Stryker) in the case and control group according to: (1) control group with standard balancing techniques used and sensor data obtained in blinded fashion and not used to balance the TKR implant, (2) experimental case group with sensor guided balancing where sensor data is used to balance the TKR within defined parameters.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo elective primary unilateral TKR for a diagnosis of osteoarthritis to be performed at the study site by the primary investigators
- •Willingness and ability to give informed consent.
排除标准
- •Inflammatory arthropathy
- •Ligament insufficiencies
- •Contraindications to posterior cruciate retaining TKR including: deformity >15 degrees or fixed-flexion contracture >15 degrees
- •Previous high tibial osteotomy
- •Scheduled to undergo sequential bilateral TKR under one anesthetic
- •Scheduled to undergo revision TKR surgery
- •Neuromuscular disorder limiting mobility or ability to comply with physiotherapy
- •Previous recurrent deep knee infection
- •Major bone loss requiring structural bone graft or augmented components
- •Functionally limiting peripheral vascular disease
- •Patients receiving associated worker's compensation benefits (WSIB)
- •Ethanol/drug abuse/psychiatric disorder
- •Inability or unwillingness to give written informed consent to participate
研究组 & 干预措施
Standard Soft Tissue Balancing
In the control group where the sensor device is not used in optimization of knee balance and alignment, definitive implants will be cemented in place and the sensor trial inserted using a thickness based on prior standard bearing insert trialing. Peak load data will be captured intraoperatively through full ROM. Custom shims will be affixed to the sensor to replicate thickness of the standard trial. The knee will then be cycled and loads recorded in the medial and lateral compartments at 10, 45 and 90 degrees of flexion. The surgeon will be blinded to the sensor output and the system will be located outside of their visual field.
干预措施: Standard Soft Tissue Balancing (Procedure)
Sensor Guided Soft Tissue Balancing
In the experimental group where the sensor device is used to optimize balance and alignment, the sensor trial will be inserted and tibial baseplate rotated until medial and lateral femoral contact points are parallel on the sensor output. Quantitative balance is defined as a mediolateral intercompartmental loading difference of ≤15 pounds. Flexion balance is achieved when femoral contact point position is within the midposterior third of the tibial insert and intercompartmental loads are balanced. Loads in the medial and lateral compartments are recorded at 10, 45 and 90 degrees. If compartment loads differ by >15 lbs between compartments, unbalanced, further soft tissue release/bone resection will be done to achieve a side to side compartment pressure difference of <15 lbs through ROM.
干预措施: Sensor Guided Soft Tissue Balancing (Procedure)
结局指标
主要结局
Rate of Unbalanced TKRs
时间窗: Intraoperative at end of procedure prior to wound closure
The rate of unbalanced TKRs will be assessed based on the Verasense sensor device quantitative definition of a well balanced knee. A well balanced knee is defined as having a mediolateral intercompartmental loading difference of ≤15 pounds through ROM \[Gustke et al., Walker et al\].
次要结局
- Clinical knee function: extension lag(Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative)
- Knee Society Score(Preoperative, 6 weeks, 6 months and 1 year postoperative)
- Clinical knee function: anteroposterior stability(Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative)
- Oxford Knee Score(Preoperative, 6 weeks, 6 months and 1 year postoperative)
- Patient satisfaction(1 year postoperative)
- Clinical knee function: varus/valgus alignment(Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative)
- Clinical knee function: anatomic alignment(Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative)
- Clinical knee function: knee ROM(Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative)
研究者
Mitch Winemaker
Chief Orthopedic Surgery, Hamilton Health Sciences Juravinski Hospital
Hamilton Health Sciences Corporation