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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
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.
Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
Towson Orthopaedic Associates
Baltimore, Maryland, United States
Summit Orthopaedics, LTD
Saint Paul, Minnesota, United States
OrthoCarolina
Charlotte, North Carolina, United States
Valley Orthopaedic Associates
Renton, Washington, United States
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.
Time frame: 12 weeks postoperatively (when subject has reached full knee extension)
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
Time frame: 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
Time frame: 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
Time frame: During the Procedure
Coronal Alignment Femoral and Tibial
Femoral Component to mechanical axis (degrees) and Tibial component to mechanical axis (degrees)
Time frame: 3-months
Sagittal Component Alignment
Sagittal Component Alignment analyzed and reported at 3- months
Time frame: Collected at Pre-Op, 3 months
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