Comparison of In Vivo Alignment With TruMatch™ Personalized Solutions Compared to Conventional Instrumentation in Total Knee Replacement (TKR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 4
- 主要终点
- Mechanical Axis Alignment(Absolute Value Measured in Degrees)Using 51 Inch Long Leg Films
研究概览
简要总结
This investigation is intended to provide clinical information about alignment using TruMatch™ and to compare the results to a conventional total knee replacement. TruMatch™ will be compared to a historical control study, which compares alignment results of computer aided surgery (CAS) and conventional surgical techniques.
The purpose of this investigation is to determine whether TruMatch™ alignment is non-inferior to alignment achieved with conventional instrumentation. This investigation will compare long leg alignment in total knee replacement achieved by the two types of procedures. Radiographic analysis will be performed by the same independent radiographic reviewer as the historical control study.
详细描述
The study is designed as a prospective, multi-center, non-randomized, clinical investigation to determine whether TruMatch™ alignment is non-inferior to alignment achieved in a recently completed study (historical control) with conventional instrumentation.
Each enrolled Subject will undergo a total knee replacement using the TruMatch™ surgical technique. This investigation will require the Subject to be followed once postoperatively to collect radiographs. Follow-up will occur typically 2 to 12 weeks after surgery and when the Subject can achieve full leg extension (+/-5 degrees) and can tolerate weight-bearing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects meeting all of the following specific criteria will be considered for participation in the study:
- •Subject is male or female and between the ages of 18 and 80 years old, inclusive.
- •Subject requires a primary total knee replacement and is considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol.
- •Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy.
- •Subject has given consent to the transfer of his/her information to DePuy.
- •Subject, who, in the opinion of the Clinical Investigator at the time of preoperative planning, are suitable for implantation using TruMatch™ instrumentation and whose surgical plan (patient proposal) is approved. For example, no femoral nails/bone plates that extend into the knee, i.e. within 8cm of joint line; no metal device that could cause CT scatter about the knee and no deformities greater than 15 degrees of fixed varus, valgus, or flexion
排除标准
- •Subjects will be excluded from participation in the trial if they meet any of the following criteria:
- •The Subject has, in the opinion of the Investigator, an existing condition that would compromise their participation and follow-up in this study.
- •The Subject is a woman who is pregnant or lactating.
- •The Subject is a known drug or alcohol abuser or has a psychological disorder that could affect follow-up care or treatment outcomes.
- •The Subject has participated in a clinical investigation with an investigational product in the last 3 months.
- •The Subject is currently involved in any personal injury litigation, medical-legal or worker's compensations claims.
- •The Subject has previously had a prosthetic knee replacement device (any type including unicompartmental, total knee arthroplasty, patellofemoral arthroplasty) of the affected knee or a previous patellectomy.
- •The Subject presents ankylosis of the hip joint on the side to be treated or previous ipsilateral UTO/HTO.
- •The Subject requires simultaneous bilateral total knee replacements.
- •The Subject had a contralateral TKA and that knee was previously entered in the study.
- •Subject in whom the surgeon intends to implant a knee prosthesis that is not the cruciate retaining or posterior substituting PFC Sigma total knee arthroplasty.
- •Subjects who have inflammatory arthritis
研究组 & 干预措施
TruMatch™ Personalized Solutions
Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
干预措施: TruMatch™ Personalized Solutions (Other)
Historical Control
Total Knee Arthroplasty (PFC Sigma System) implanted using conventional and CAS surgical techniques without TruMatch™ instrumentation.
干预措施: Total Knee Arthroplasty with Conventional Instrumentation. (Device)
结局指标
主要结局
Mechanical Axis Alignment(Absolute Value Measured in Degrees)Using 51 Inch Long Leg Films
时间窗: 12 weeks postoperatively (when subject has reached full knee extension)
Limb alignment in TKR is important for accurate implant positioning. It is measured by looking at the mechanical axis of the limb. This axis is an imaginary line that starts at center of the femoral head and ends in the center of the talus. In a knee with normal alignment, this line (axis) passes near the joint center. Before surgery, the planned joint angle is recorded. This study measured the difference between the mechanical axis angle reached after surgery and the planned angle. Subjects with a mechanical alignment within 3 degrees of the planned angle were considered a success.
次要结局
- Tourniquet Time Measured in Minutes During the Procedure for TruMatch and Conventional Instruments(During the Procedure)
- Tourniquet to 1st Bone Cut Measured in Minutes During the Procedure for TruMatch and Conventional Instruments(During the Procedure)
- Sagittal Component Alignment(Collected at Pre-Op, 3 months)
- Compare Intraoperative Time Data During Procedure for Skin-to-skin Time in Minutes(During the Procedure)
- Coronal Alignment Femoral and Tibial(3-months)