Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01301950|
Recruitment Status : Completed
First Posted : February 23, 2011
Results First Posted : September 5, 2014
Last Update Posted : June 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Other: Custom Patient Instrumentation Other: Conventional Instruments||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Surgical Time and Efficiency of Total Knee Arthroplasty Using TruMatch® Personalized Solutions Compared to Conventional Total Knee Arthroplasty|
|Actual Study Start Date :||May 1, 2010|
|Actual Primary Completion Date :||August 1, 2013|
|Actual Study Completion Date :||August 1, 2013|
Active Comparator: TruMatch® Personalized Solutions
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
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
Other Name: TruMatch® Personalized Solutions
Active Comparator: Conventional Total Knee Replacement
Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
Other: Conventional Instruments
Total Knee Arthroplasty implanted using conventional instruments (non-CPI) and surgical technique.
- Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements [ Time Frame: Intraoperative (Time from first incision to first stitch) ]Skin-to skin time for conventional versus TruMatch® primary total knee replacements (recorded by Investigator on Operative case report forms).
- Operating Room Setup - Operating Room Cleaned up From Previous Case to Surgical Draping Complete [ Time Frame: Intraoperative (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]
- Turnover Time (Time to Clean Operating Room After Surgery is Completed) [ Time Frame: Intraoperative (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].
- Costs Associated With Conventional Versus TruMatch® Total Knee Arthroplasty Surgical Procedures [ Time Frame: Intraoperative (Total duration of procedure) ]Compare costs associated with surgery using conventional surgical technique versus TruMatch® primary total knee replacements .
- To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location [ Time Frame: Intraoperative ]
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): NCT01301950
|United States, Indiana|
|Center for Hip and Knee Surgery|
|Mooresville, Indiana, United States, 46158|
|United States, Oklahoma|
|Bartlesville, Oklahoma, United States, 74006|
|United States, Virginia|
|Reston, Virginia, United States, 20190|
|Principal Investigator:||Carl Painter||Pinnacle Orthopaedics|