Alignment Comparison Between TruMatch™ Personalized Solutions and Conventional Total Knee Replacement Instrumentation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of In Vivo Alignment With TruMatch™ Personalized Solutions Compared to Conventional Instrumentation in Total Knee Replacement (TKR)

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Other: TruMatch™ Personalized Solutions
* Device: Total Knee Arthroplasty with Conventional Instrumentation.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TruMatch™ Personalized Solutions<br>Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions | Other: TruMatch™ Personalized Solutions<br>* TruMatch™ Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch™ is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.<br>|
| Other: Historical Control<br>Total Knee Arthroplasty (PFC Sigma System) implanted using conventional and CAS surgical techniques without TruMatch™ instrumentation. | Device: Total Knee Arthroplasty with Conventional Instrumentation.<br>* Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical Axis Alignment(Absolute Value Measured in Degrees)Using 51 Inch Long Leg Films | 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. | 12 weeks postoperatively (when subject has reached full knee extension) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Intraoperative Time Data During Procedure for Skin-to-skin Time in Minutes | Intraoperative (skin to skin) time was measured to the nearest minute. TruMatch personalized Solutions and Conventional instrumentation outcomes are provided | During the Procedure | 
| Tourniquet Time Measured in Minutes During the Procedure for TruMatch and Conventional Instruments | Intraoperative Tourniquet time was measured to the nearest minute. TruMatch and Conventional instrumentation outcomes are provided | During the Procedure | 
| Tourniquet to 1st Bone Cut Measured in Minutes During the Procedure for TruMatch and Conventional Instruments | Intraoperative Tourniquet to 1st Bone Cut time was measured to the nearest minute. TruMatch and Conventional instrumentation outcomes provided | During the Procedure | 
| Coronal Alignment Femoral and Tibial | Femoral Component to mechanical axis (degrees) and Tibial component to mechanical axis (degrees) | 3-months | 
| Sagittal Component Alignment | Sagittal Component Alignment analyzed and reported at 3- months | Collected at Pre-Op, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasties, Knee Replacement, Arthroplasties, Replacement, Knee, Arthroplasty, Knee Replacement, Knee Replacement Arthroplasties, Knee Replacement Arthroplasty, Knee Replacement, Total, Replacement Arthroplasties, Knee, Replacement Arthroplasty, Knee, Replacement, Total Knee, Total Knee Replacement