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 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
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.
Interventions
OTHERCustom 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
Total Knee Arthroplasty implanted using conventional instruments (non-CPI) and surgical technique.
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
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location | Intraoperative | — |
| Operating Room Setup - Operating Room Cleaned up From Previous Case to Surgical Draping Complete | 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) | 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 | Intraoperative (Total duration of procedure) | Compare costs associated with surgery using conventional surgical technique versus TruMatch® primary total knee replacements . |
Countries
United States
Participant flow
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 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 | 15 |
| Conventional Total Knee Replacement Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Surgery was cancelled by patient | 0 | 1 |
Baseline characteristics
| Characteristic | TruMatch® Personalized Solutions | Conventional Total Knee Replacement | Total |
|---|---|---|---|
| Age, Continuous | 62.9 years STANDARD_DEVIATION 12.9 | 62.7 years STANDARD_DEVIATION 9.1 | 62.8 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 6 Participants | 11 Participants | 17 Participants |
| Sex: Female, Male Male | 9 Participants | 4 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 15 |
| serious Total, serious adverse events | 0 / 14 | 0 / 15 |
Outcome results
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).
Time frame: Intraoperative (Time from first incision to first stitch)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Total Knee Replacement | Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements | 65.8 minutes | Standard Deviation 12.3 |
| TruMatch® Personalized Solutions | Surgical Procedure Time to Compare Skin-to-Skin Time for Conventional Versus TruMatch® Primary Total Knee Replacements | 67.3 minutes | Standard Deviation 20.6 |
Comparison: The null hypothesis was no difference in skin-to-skin time. The alternative hypothesis was that the TruMatch group time was less than the conventional group. Statistical power was anticipated to be 86% with 40 enrolled subjects based upon a Cohen's D effect size of 1. The Sponsor had difficulty identifying and recruiting sites suitable for participation. The statistically required sample size (N=40) was therefore not obtained, causing the group comparison to be statistically underpowered.p-value: 0.54ANOVA
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 .
Time frame: Intraoperative (Total duration of procedure)
Population: No cost data were collected, resulting in a sample size of 0.
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 \[minutes\]
Time frame: Intraoperative (Operating Room cleaned up from previous case to surgical draping complete)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Total Knee Replacement | Operating Room Setup - Operating Room Cleaned up From Previous Case to Surgical Draping Complete | 28.9 minutes | Standard Deviation 15 |
| TruMatch® Personalized Solutions | Operating Room Setup - Operating Room Cleaned up From Previous Case to Surgical Draping Complete | 28.8 minutes | Standard Deviation 14.4 |
Secondary
To Compare the Differences in Operating Room Efficiency as a Function of Institution Type and Geographical Location
Time frame: Intraoperative
Population: No operating room efficiency data was analyzed as a function of geography and institution, resulting in a sample size of 0.
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 \[minutes\].
Time frame: Intraoperative (Time to clean Operating Room after surgery is completed)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Total Knee Replacement | Turnover Time (Time to Clean Operating Room After Surgery is Completed) | 10.1 minutes | Standard Deviation 4.8 |
| TruMatch® Personalized Solutions | Turnover Time (Time to Clean Operating Room After Surgery is Completed) | 11.4 minutes | Standard Deviation 2.8 |