This study is designed to compare the surgical efficiency of TruMatch® Personalized Solutions surgical technique compared to conventional surgical technique. Specifically, the purpose of this study is to collect time data to enhance the existing economic model.
The study is designed as a prospective, multi-center, controlled, non-randomized, clinical investigation to compare the efficiency of TruMatch® Personalized Solutions surgical technique compared to conventional surgical technique.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation (CPI). 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 implanted using conventional instruments (non-CPI) and surgical technique.
Center for Hip and Knee Surgery
Mooresville, Indiana, United States
Pinnacle Orthopaedics
Bartlesville, Oklahoma, United States
Commonwealth Orthopaedics
Reston, Virginia, United States
Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements
Skin-to skin time for conventional versus TruMatch® primary total knee replacements (recorded by Investigator on Operative case report forms).
Time frame: Intraoperative (Time from first incision to first stitch)
Operating Room Setup - Operating Room Cleaned up From Previous Case to Surgical Draping Complete
Operating Room setup time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis \[minutes\]
Time frame: Intraoperative (Operating Room cleaned up from previous case to surgical draping complete)
Turnover Time (Time to Clean Operating Room After Surgery is Completed)
Turnover Time for conventional versus TruMatch® primary total knee replacements as recorded by video time analysis \[minutes\].
Time frame: Intraoperative (Time to clean Operating Room after surgery is completed)
Costs Associated With Conventional Versus TruMatch® Total Knee Arthroplasty Surgical Procedures
Compare costs associated with surgery using conventional surgical technique versus TruMatch® primary total knee replacements .
Time frame: Intraoperative (Total duration of procedure)
To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location
Time frame: Intraoperative
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