Osteoarthritis, Knee
Conditions
Keywords
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
Brief summary
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.
Detailed description
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.
Interventions
OTHERTruMatch™ Personalized Solutions
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.
DEVICETotal Knee Arthroplasty with Conventional Instrumentation.
Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
Sponsors
DePuy Orthopaedics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subjects meeting all of the following specific criteria will be considered for participation in the study: * 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 has given consent to the transfer of his/her information to DePuy. * Subject, who, in the opinion of the Clinical Investigator at the time of preoperative planning, are suitable for implantation using TruMatch™ instrumentation and whose surgical plan (patient proposal) is approved. For example, no femoral nails/bone plates that extend into the knee, i.e. 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
Exclusion criteria
* Subjects will be excluded from participation in the trial if they meet any of the following criteria: * The Subject has, in the opinion of the Investigator, an existing condition that would compromise their participation and follow-up in this study. * The Subject is a woman who is pregnant or lactating. * The Subject is a known drug or alcohol abuser or has a psychological disorder that could affect follow-up care or treatment outcomes. * 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 including unicompartmental, total knee arthroplasty, patellofemoral arthroplasty) of the affected knee or a previous patellectomy. * The Subject presents ankylosis of the hip joint on the side to be treated or previous ipsilateral UTO/HTO. * 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 the cruciate retaining or posterior substituting PFC Sigma total knee arthroplasty. * Subjects who have inflammatory arthritis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical Axis Alignment(Absolute Value Measured in Degrees)Using 51 Inch Long Leg Films | 12 weeks postoperatively (when subject has reached full knee extension) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare Intraoperative Time Data During Procedure for Skin-to-skin Time in Minutes | During the Procedure | Intraoperative (skin to skin) time was measured to the nearest minute. TruMatch personalized Solutions and Conventional instrumentation outcomes are provided |
| Tourniquet Time Measured in Minutes During the Procedure for TruMatch and Conventional Instruments | During the Procedure | Intraoperative Tourniquet time was measured to the nearest minute. TruMatch and Conventional instrumentation outcomes are provided |
| Tourniquet to 1st Bone Cut Measured in Minutes During the Procedure for TruMatch and Conventional Instruments | During the Procedure | Intraoperative Tourniquet to 1st Bone Cut time was measured to the nearest minute. TruMatch and Conventional instrumentation outcomes provided |
| Coronal Alignment Femoral and Tibial | 3-months | Femoral Component to mechanical axis (degrees) and Tibial component to mechanical axis (degrees) |
| Sagittal Component Alignment | Collected at Pre-Op, 3 months | Sagittal Component Alignment analyzed and reported at 3- months |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| TruMatch™ Personalized Solutions Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions | 66 |
| Total Knee Arthroplasty With Conventional Instrumentation Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation. | 86 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not meet criteria for analysis | 7 | 0 |
| Overall Study | No alignment data | 2 | 15 |
Baseline characteristics
| Characteristic | TruMatch™ Personalized Solutions | Total Knee Arthroplasty With Conventional Instrumentation | Total |
|---|---|---|---|
| Age, Continuous | 66.4 years STANDARD_DEVIATION 8.4 | 64.6 years STANDARD_DEVIATION 7.6 | 65.3 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States United States | 66 Participants | 86 Participants | 152 Participants |
| Sex: Female, Male Female | 41 Participants | 57 Participants | 98 Participants |
| Sex: Female, Male Male | 25 Participants | 29 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 64 | 17 / 84 |
| serious Total, serious adverse events | 0 / 64 | 0 / 84 |
Outcome results
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.
Time frame: 12 weeks postoperatively (when subject has reached full knee extension)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TruMatch™ Personalized Solutions | Mechanical Axis Alignment(Absolute Value Measured in Degrees)Using 51 Inch Long Leg Films | 2.15 Absolute value in degrees | Standard Deviation 1.85 |
| Total Knee Arthroplasty With Conventional Instrumentation | Mechanical Axis Alignment(Absolute Value Measured in Degrees)Using 51 Inch Long Leg Films | 2.14 Absolute value in degrees | Standard Deviation 1.84 |
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
Time frame: During the Procedure
Population: Per protocol, to compare intraoperative time data, average skin to skin surgical time for knees, when using TruMatch and Conventional instrumentation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TruMatch™ Personalized Solutions | Compare Intraoperative Time Data During Procedure for Skin-to-skin Time in Minutes | 74.6 Minutes | Standard Deviation 15.3 |
| Total Knee Arthroplasty With Conventional Instrumentation | Compare Intraoperative Time Data During Procedure for Skin-to-skin Time in Minutes | 79.8 Minutes | Standard Deviation 20 |
Secondary
Coronal Alignment Femoral and Tibial
Femoral Component to mechanical axis (degrees) and Tibial component to mechanical axis (degrees)
Time frame: 3-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TruMatch™ Personalized Solutions | Coronal Alignment Femoral and Tibial | 89.8 Degrees | Standard Deviation 1.3 |
| Total Knee Arthroplasty With Conventional Instrumentation | Coronal Alignment Femoral and Tibial | 90.0 Degrees | Standard Deviation 1.7 |
| Tibial Component to Mechanical Axis TruMatch | Coronal Alignment Femoral and Tibial | 90.0 Degrees | Standard Deviation 1.1 |
| Tibial Component to Mechanical Axis Conventional | Coronal Alignment Femoral and Tibial | 90.5 Degrees | Standard Deviation 1.9 |
Secondary
Sagittal Component Alignment
Sagittal Component Alignment analyzed and reported at 3- months
Time frame: Collected at Pre-Op, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TruMatch™ Personalized Solutions | Sagittal Component Alignment | 90.1 Degrees | Standard Deviation 2.5 |
| Total Knee Arthroplasty With Conventional Instrumentation | Sagittal Component Alignment | 89.8 Degrees | Standard Deviation 2.2 |
| Tibial Component to Mechanical Axis TruMatch | Sagittal Component Alignment | 88.5 Degrees | Standard Deviation 2.8 |
| Tibial Component to Mechanical Axis Conventional | Sagittal Component Alignment | 86.7 Degrees | Standard Deviation 2.7 |
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
Time frame: During the Procedure
Population: Per protocol, to compare intraoperative Tourniquet time data during knee replacement when using TruMatch and Conventional instrumentation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TruMatch™ Personalized Solutions | Tourniquet Time Measured in Minutes During the Procedure for TruMatch and Conventional Instruments | 61.7 Minutes | Standard Deviation 16.3 |
| Total Knee Arthroplasty With Conventional Instrumentation | Tourniquet Time Measured in Minutes During the Procedure for TruMatch and Conventional Instruments | 60.5 Minutes | Standard Deviation 16.9 |
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
Time frame: During the Procedure
Population: Per protocol, to compare intraoperative Tourniquet time data during knee replacement when using TruMatch, Conventional instrumentation and Computer Assisted Surgery (CAS)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TruMatch™ Personalized Solutions | Tourniquet to 1st Bone Cut Measured in Minutes During the Procedure for TruMatch and Conventional Instruments | 9.0 Minutes | Standard Deviation 2.5 |
| Total Knee Arthroplasty With Conventional Instrumentation | Tourniquet to 1st Bone Cut Measured in Minutes During the Procedure for TruMatch and Conventional Instruments | 10.3 Minutes | Standard Deviation 4 |