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To ensure a successful outcome after total knee replacement (TKR) soft tissue balance and proper implant position are very important during the surgical procedure. Soft tissues are structures in the knee including ligaments, muscles, tendons, and menisci that stabilize and cushion the knee joint. Lack of proper soft tissue balance or imprecise implant positioning may result in knee stiffness, pain, instability and limited range of motion (ROM). This may result in implant failure and the need for revision surgery. As part of standard practice orthopedic surgeons use a manual knee balancer device to help guide soft tissue balancing to achieve optimal knee balance. New sensor-assisted technology can provide surgeons with measurable information to help achieve soft tissue balancing, providing surgeons with immediate visual feedback during the surgery. This feedback, transmitted wirelessly by the sensor, gives surgeons electronic information on soft tissue balance and implant position.The purpose of this study is to determine if a sensor guided soft tissue balancing device (Verasense) is more effective at balancing the knee during surgery as compared to standard soft tissue balancing performed with a manual balancer device.
The study is that of a prospective double-blind randomized controlled trial of patients presenting for elective primary TKR to compare the outcomes of TKR using conventional soft tissue balancing with a tensiometer device versus augmenting the soft tissue balancing with the OrthoSensor VerasenseTM sensor device. The primary outcome will be rate of unbalanced TKRs based on the quantitative Verasense definition of a well balanced knee defined as a mediolateral intercompartmental loading difference of ≤15 pounds through ROM. Secondary outcomes include differences in clinical outcome scores and patient satisfaction among sensor guided cases and controls.
Patients will be randomized to receive TKR with the Triathlon total knee system (Stryker) in the case and control group according to: (1) control group with standard balancing techniques used and sensor data obtained in blinded fashion and not used to balance the TKR implant, (2) experimental case group with sensor guided balancing where sensor data is used to balance the TKR within defined parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Soft Tissue Balancing | Active Comparator | In the control group where the sensor device is not used in optimization of knee balance and alignment, definitive implants will be cemented in place and the sensor trial inserted using a thickness based on prior standard bearing insert trialing. Peak load data will be captured intraoperatively through full ROM. Custom shims will be affixed to the sensor to replicate thickness of the standard trial. The knee will then be cycled and loads recorded in the medial and lateral compartments at 10, 45 and 90 degrees of flexion. The surgeon will be blinded to the sensor output and the system will be located outside of their visual field. |
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| Sensor Guided Soft Tissue Balancing | Experimental | In the experimental group where the sensor device is used to optimize balance and alignment, the sensor trial will be inserted and tibial baseplate rotated until medial and lateral femoral contact points are parallel on the sensor output. Quantitative balance is defined as a mediolateral intercompartmental loading difference of ≤15 pounds. Flexion balance is achieved when femoral contact point position is within the midposterior third of the tibial insert and intercompartmental loads are balanced. Loads in the medial and lateral compartments are recorded at 10, 45 and 90 degrees. If compartment loads differ by >15 lbs between compartments, unbalanced, further soft tissue release/bone resection will be done to achieve a side to side compartment pressure difference of <15 lbs through ROM. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensor Guided Soft Tissue Balancing | Procedure | Primary TKR with soft tissue balancing with a sensor guided device. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Unbalanced TKRs | The rate of unbalanced TKRs will be assessed based on the Verasense sensor device quantitative definition of a well balanced knee. A well balanced knee is defined as having a mediolateral intercompartmental loading difference of ≤15 pounds through ROM [Gustke et al., Walker et al]. | Intraoperative at end of procedure prior to wound closure |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score | Overall clinical function as measured by Knee Society Score | Preoperative, 6 weeks, 6 months and 1 year postoperative |
| Oxford Knee Score | Subjective function as measured by Oxford Knee Score patient report outcome measure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitch Winemaker, MD, FRCSC | Hamilton Health Sciences Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Sciences Juravinski Hospital | Hamilton | Ontario | L8V 1C3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24269069 | Background | Gustke KA, Golladay GJ, Roche MW, Elson LC, Anderson CR. A new method for defining balance: promising short-term clinical outcomes of sensor-guided TKA. J Arthroplasty. 2014 May;29(5):955-60. doi: 10.1016/j.arth.2013.10.020. Epub 2013 Oct 24. | |
| 24103411 | Background | Walker PS, Meere PA, Bell CP. Effects of surgical variables in balancing of total knee replacements using an instrumented tibial trial. Knee. 2014 Jan;21(1):156-61. doi: 10.1016/j.knee.2013.09.002. Epub 2013 Sep 19. |
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| Standard Soft Tissue Balancing | Procedure | Primary TKR with soft tissue balancing with a standard of care manual tensiometer device. |
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| Preoperative, 6 weeks, 6 months and 1 year postoperative |
| Patient satisfaction | Patient satisfaction with total knee replacement; likert scale | 1 year postoperative |
| Clinical knee function: varus/valgus alignment | Assessment of clinical knee function | Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative |
| Clinical knee function: anteroposterior stability | Assessment of clinical knee function | Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative |
| Clinical knee function: extension lag | Assessment of clinical knee function | Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative |
| Clinical knee function: anatomic alignment | Assessment of clinical knee function | Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative |
| Clinical knee function: knee ROM | Assessment of clinical knee function | Preoperative, intraoperative, 6 weeks, 6 months and 1 year postoperative |