Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty Using TruMatch® Personalized Solutions Compared to Conventional Total Knee Arthroplasty

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Other: Custom Patient Instrumentation
* Other: Conventional Instruments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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, in the opinion of the Clinical Investigator, is able to understand this clinical investigation, and co-operate with investigational procedures. Subject, who, in the opinion of the Clinical Investigator, are suitable for implantation using TruMatch™ instrumentation. For example, no femoral nails/bone plates that extend into the knee, ie. 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 contracture are consistent with TruMatch™ instrumentation. Exclusion Criteria: The Subject is a woman who is pregnant or lactating. 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) of the affected knee. 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 in the PFC Sigma primary knee system. Subject who has inflammatory arthritis. Subject who has a Body Mass Index (BMI) of ≥ 40. (Please see Table 2-1: Definition of Terms, for BMI definition and calculation formulas).

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 |
| --- | --- |
| Active Comparator: 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 (Custom Patient Instrumentation) | Other: Custom Patient Instrumentation<br>* 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<br>* Other names: TruMatch® Personalized Solutions;|
| Active Comparator: Conventional Total Knee Replacement<br>Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments | Other: Conventional Instruments<br>* Total Knee Arthroplasty implanted using conventional instruments (non-CPI) and surgical technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Intraoperative (Time from first incision to first stitch) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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] | 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]. | 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 . | Intraoperative (Total duration of procedure) | 
| To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location |  | Intraoperative | 

 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