Alignment Comparison Between TruMatch™ Personalized Solutions and Conventional Total Knee Replacement Instrumentation
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|ClinicalTrials.gov Identifier: NCT01108237|
Recruitment Status : Completed
First Posted : April 21, 2010
Results First Posted : May 21, 2012
Last Update Posted : January 24, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Other: TruMatch™ Personalized Solutions Device: Total Knee Arthroplasty with Conventional Instrumentation.||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of In Vivo Alignment With TruMatch™ Personalized Solutions Compared to Conventional Instrumentation in Total Knee Replacement (TKR)|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
TruMatch™ Personalized Solutions
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
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 and CAS surgical techniques without TruMatch™ instrumentation.
Device: Total Knee Arthroplasty with Conventional Instrumentation.
Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
- Mechanical Axis Alignment(Absolute Value Measured in Degrees)Using 51 Inch Long Leg Films [ Time Frame: 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.
- Compare Intraoperative Time Data (Skin-to-skin, Tourniquet, Tourniquet to Bone) [ Time Frame: During the Procedure ]
- Compare AP Tibial/Femoral Component Alignment [ Time Frame: Pre-op, 3 months ]
- Sagittal Component Alignment [ Time Frame: Pre-Op, 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108237
|United States, Maryland|
|Towson Orthopaedic Associates|
|Baltimore, Maryland, United States, 21204|
|United States, Minnesota|
|Summit Orthopaedics, LTD|
|St. Paul, Minnesota, United States, 55102|
|United States, North Carolina|
|Charlotte, North Carolina, United States, 28207|
|United States, Washington|
|Valley Orthopaedic Associates|
|Renton, Washington, United States, 98055-5791|
|Study Director:||Saleem Himden, BA||DePuy Orthopaedics|