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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TruMatch™ Personalized Solutions | Other | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions |
|
| Historical Control | Other | Total Knee Arthroplasty (PFC Sigma System) implanted using conventional and CAS surgical techniques without TruMatch™ instrumentation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TruMatch™ Personalized Solutions | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical Axis Alignment(Absolute Value Measured in Degrees)Using 51 Inch Long Leg Films | 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. | 12 weeks postoperatively (when subject has reached full knee extension) |
| Measure | Description | Time Frame |
|---|---|---|
| Compare Intraoperative Time Data During Procedure for Skin-to-skin Time in Minutes | Intraoperative (skin to skin) time was measured to the nearest minute. TruMatch personalized Solutions and Conventional instrumentation outcomes are provided | During the Procedure |
| Tourniquet Time Measured in Minutes During the Procedure for TruMatch and Conventional Instruments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Saleem Himden, BA | DePuy Orthopaedics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Towson Orthopaedic Associates | Baltimore | Maryland | 21204 | United States | ||
| Summit Orthopaedics, LTD |
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The TruMatch (patient-specific instruments) arm of this study was a prospective, multi-center, non-randomized, clinical investigation conducted at 4 sites. The other arm of this study (conventional instruments) included 86 historical control subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | TruMatch™ Personalized Solutions | Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions |
| FG001 | Total Knee Arthroplasty With Conventional Instrumentation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Total Knee Arthroplasty with Conventional Instrumentation. | Device | Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation. |
|
Intraoperative Tourniquet time was measured to the nearest minute. TruMatch and Conventional instrumentation outcomes are provided |
| During the Procedure |
| Tourniquet to 1st Bone Cut Measured in Minutes During the Procedure for TruMatch and Conventional Instruments | Intraoperative Tourniquet to 1st Bone Cut time was measured to the nearest minute. TruMatch and Conventional instrumentation outcomes provided | During the Procedure |
| Coronal Alignment Femoral and Tibial | Femoral Component to mechanical axis (degrees) and Tibial component to mechanical axis (degrees) | 3-months |
| Sagittal Component Alignment | Sagittal Component Alignment analyzed and reported at 3- months | Collected at Pre-Op, 3 months |
| Saint Paul |
| Minnesota |
| 55102 |
| United States |
| OrthoCarolina | Charlotte | North Carolina | 28207 | United States |
| Valley Orthopaedic Associates | Renton | Washington | 98055-5791 | United States |
Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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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 |
| BG001 | Total Knee Arthroplasty With Conventional Instrumentation | Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Mechanical Axis Alignment(Absolute Value Measured in Degrees)Using 51 Inch Long Leg Films | 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. | Posted | Least Squares Mean | Standard Deviation | Absolute value in degrees | 12 weeks postoperatively (when subject has reached full knee extension) |
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| Secondary | Compare Intraoperative Time Data During Procedure for Skin-to-skin Time in Minutes | Intraoperative (skin to skin) time was measured to the nearest minute. TruMatch personalized Solutions and Conventional instrumentation outcomes are provided | Per protocol, to compare intraoperative time data, average skin to skin surgical time for knees, when using TruMatch and Conventional instrumentation | Posted | Mean | Standard Deviation | Minutes | During the Procedure | Knees | Knees |
|
| |||||||||||||||||||||||||||
| Secondary | Tourniquet Time Measured in Minutes During the Procedure for TruMatch and Conventional Instruments | Intraoperative Tourniquet time was measured to the nearest minute. TruMatch and Conventional instrumentation outcomes are provided | Per protocol, to compare intraoperative Tourniquet time data during knee replacement when using TruMatch and Conventional instrumentation | Posted | Mean | Standard Deviation | Minutes | During the Procedure | Knees | Knees |
|
| |||||||||||||||||||||||||||
| Secondary | Tourniquet to 1st Bone Cut Measured in Minutes During the Procedure for TruMatch and Conventional Instruments | Intraoperative Tourniquet to 1st Bone Cut time was measured to the nearest minute. TruMatch and Conventional instrumentation outcomes provided | Per protocol, to compare intraoperative Tourniquet time data during knee replacement when using TruMatch, Conventional instrumentation and Computer Assisted Surgery (CAS) | Posted | Mean | Standard Deviation | Minutes | During the Procedure | Knees | Knees |
|
| |||||||||||||||||||||||||||
| Secondary | Coronal Alignment Femoral and Tibial | Femoral Component to mechanical axis (degrees) and Tibial component to mechanical axis (degrees) | Posted | Mean | Standard Deviation | Degrees | 3-months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Sagittal Component Alignment | Sagittal Component Alignment analyzed and reported at 3- months | Posted | Mean | Standard Deviation | Degrees | Collected at Pre-Op, 3 months |
|
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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 | 0 | 64 | 0 | 64 | ||
| EG001 | Total Knee Arthroplasty With Conventional Instrumentation | Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation. | 0 | 84 | 17 | 84 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal | Musculoskeletal and connective tissue disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sam Himden | DePuy Orthopaedics, Inc. | 574-372-7231 | SHimden@its.jnj.com |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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| Male |
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| Knees |
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| Knees |
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| Knees |
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| Participants |
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| Counts |
|---|
| Participants |
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