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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TruMatch® Personalized Solutions | Active Comparator | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch® Personalized Solutions (Custom Patient Instrumentation) |
|
| Conventional Total Knee Replacement | Active Comparator | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Custom Patient Instrumentation | Other | 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 |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl Painter | Pinnacle Orthopaedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Hip and Knee Surgery | Mooresville | Indiana | 46158 | United States | ||
| Pinnacle Orthopaedics |
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Total Knee Replacement | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments |
| FG001 | TruMatch® Personalized Solutions | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: 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 patients' 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects who were consented prior to surgery were included in the analysis of baseline characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | TruMatch® Personalized Solutions | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch® Personalized Solutions Instrument: 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | minutes | Intraoperative (Time from first incision to first stitch) |
|
Intraoperative
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TruMatch™ Personalized Solutions | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions Instrument: 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 |
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A statistically powered sample size was not obtained; Two secondary objectives (compare costs & compare differences in OR efficiency as a function of institution type & geographic location) could not be assessed as originally intended by the protocol
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sam Himden, Clinical Portfolio Leader | DePuy Synthes | 574-372-7231 | shimden@its.jnj.com |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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|
|
| Conventional Instruments | Other | Total Knee Arthroplasty implanted using conventional instruments (non-CPI) and surgical technique. |
|
| 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 |
| Bartlesville |
| Oklahoma |
| 74006 |
| United States |
| Commonwealth Orthopaedics | Reston | Virginia | 20190 | United States |
| BG001 | Conventional Total Knee Replacement | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | 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] | Posted | Mean | Standard Deviation | minutes | Intraoperative (Operating Room cleaned up from previous case to surgical draping complete) |
|
|
|
| Secondary | 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]. | 1 site (9 subjects) was excluded from Turnover Time analysis as this substep could not be accurately assessed due to unexpected difficulties during video collection. | Posted | Mean | Standard Deviation | minutes | Intraoperative (Time to clean Operating Room after surgery is completed) |
|
|
|
| Secondary | 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 . | No cost data were collected, resulting in a sample size of 0. | Posted | Intraoperative (Total duration of procedure) |
|
|
| Secondary | To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location | No operating room efficiency data was analyzed as a function of geography and institution, resulting in a sample size of 0. | Posted | Intraoperative |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Conventional Total Knee Replacement | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments | 0 | 15 | 0 | 15 |
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| D012216 |
| Rheumatic Diseases |