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This is a randomized, controlled, blinded prospective study comparing the use of the usual cutting guides with a palm-sized digital surgical navigation system in unilateral total knee arthroplasty. Analysis of pre- and post-operative X-rays will be used to compare alignment of the tibial (shinbone) implant components. The investigators expect that the FDA-approved hand-held surgical navigation device will increase the accuracy and precision of the tibial cut by telling the surgeon the exact position of the cutting block before the surgeon makes the cut, allowing minor adjustments to be made. The investigators expect the conventional device to take less time to use, but that this difference will decrease as the surgeon becomes more familiar with the device. The investigators expect the intraoperative measurements acquired by the KneeAlign system to strongly correlate with the radiographic alignments measured postoperatively.
Medical records, private office charts, and electronic medical records will be utilized by the co-investigators to review data on patients who fit the previously stated inclusion criteria. Demographic data including age, gender, height (cm), and weight (kg) will be collected. Preoperative, standing anteroposterior hip-to-ankle radiographs will be measured for the lower extremity mechanical axis, the tibiofemoral anatomic alignment, and the distal femoral and proximal tibial anatomic angles. Intraoperative time measurements for use of both the conventional extramedullary alignment guide, and the KneeAlignTM system will be measured and recorded. The time required to utilize each alignment guide will be measured in seconds, starting from the time at which the surgeon is handed the alignment guide (KneeAlignTM or conventional, extramedullary), to the time at which the surgeon is handed the oscillating saw to make the tibial cut. Of note, no intraoperative alignment measurements are required or will be recorded for the conventional, extramedullary systems, while intraoperative alignments reported by the KneeAlignTM system will be recorded when the KneeAlignTM device is used. In addition, regarding the use of conventional, extramedullary tibial guides, each surgeon will utilize the guide (regardless of manufacturer) which they currently use most frequently when performing a total knee arthroplasty. While there may be minimal differences with regards each of the surgeon's conventional guides, they are all essentially the same with regards to utilizing an extramedullary rod for alignment of the tibial resection.
Currently, a total knee replacement requires an average tourniquet time of 30-50 minutes depending on the surgeon. We estimate an approximate increase in total tourniquet time of 5-6 minutes when using the hand-held surgical navigation system.
For each procedure (either KneeAlignTM or conventional, extramedullary guides), after making the initial cut, if at any point in the procedure the surgeon re-cuts the tibia, they will be asked a series of questions postoperatively as to why they re-cut the tibia as part of the data collection. These questions will include:
This study has the potential to provide significant information regarding the clinical accuracy and precision of the KneeAlignTM system compared to that of conventional, extramedullary alignment systems. If mechanical and tibial mechanical alignment is significantly improved with the use of the KneeAlignTM system, this may encourage surgeons to utilize this device to improve postoperative alignment in total knee arthroplasty. In addition, surgeon's may find this type of hand-held system more user-friendly (in contrast to a large console, computer-assisted surgical system), and this may stimulate future investigations into similar devices for femoral component alignment, and also total hip arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional System | Active Comparator | Conventional tibial extramedullary alignment system used by surgeon during surgery. |
|
| KneeAlign System | Experimental | Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital hand-held surgical navigation system | Device | Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Tibial Component Alignment | The primary outcome will be the number of patients (percentage of patients) that met a predetermined criteria for Alignment as defined by within 2° of perpendicular to the tibial mechanical axis or 2° of a 3° posterior slope, postoperative tibial component alignment (mechanical varus/valgus, and posterior slope) as measured on postoperative standing anteroposterior hip-to-ankle radiographs, and standing, lateral knee-to-ankle radiographs, respectively. | 6 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time Required to Utilize System | The amount of time required to utilize conventional, tibial extramedullary alignment guides versus the KneeAlignTM system, which will be recorded intraoperatively. | Minutes during surgery ( Estimated time per surgery 1 hour) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Mayman, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22704226 | Result | Nam D, Weeks KD, Reinhardt KR, Nawabi DH, Cross MB, Mayman DJ. Accelerometer-based, portable navigation vs imageless, large-console computer-assisted navigation in total knee arthroplasty: a comparison of radiographic results. J Arthroplasty. 2013 Feb;28(2):255-61. doi: 10.1016/j.arth.2012.04.023. Epub 2012 Jun 14. | |
| 22681247 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional System | Conventional tibial extramedullary alignment system used by surgeon during surgery. Conventional tibial extramedullary alignment system: This is the standard of care for total knee arthroplasty. |
| FG001 | KneeAlign System | Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery. Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
A sample size of 47 patients in each cohort would provide appropriate power (beta level = 0.80, alpha level = 0.05) to detect a 20% improvement in accuracy between the two groups (i.e. a 20% decrease or increase in the number of "outliers").
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional System | Conventional tibial extramedullary alignment system used by surgeon during surgery. Conventional tibial extramedullary alignment system: This is the standard of care for total knee arthroplasty. |
| BG001 | KneeAlign System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Postoperative Tibial Component Alignment | The primary outcome will be the number of patients (percentage of patients) that met a predetermined criteria for Alignment as defined by within 2° of perpendicular to the tibial mechanical axis or 2° of a 3° posterior slope, postoperative tibial component alignment (mechanical varus/valgus, and posterior slope) as measured on postoperative standing anteroposterior hip-to-ankle radiographs, and standing, lateral knee-to-ankle radiographs, respectively. | Posted | Number | percentage of participants | 6 weeks after surgery |
|
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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 | Conventional System | Conventional tibial extramedullary alignment system used by surgeon during surgery. Conventional tibial extramedullary alignment system: This is the standard of care for total knee arthroplasty. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Mayman | Hospital for Special Surgery | 2127742024 | maymand@hss.edu |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D007592 | Joint Diseases |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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|
| Conventional tibial extramedullary alignment system | Device | This is the standard of care for total knee arthroplasty. |
|
| Nam D, Jerabek SA, Cross MB, Mayman DJ. Cadaveric analysis of an accelerometer-based portable navigation device for distal femoral cutting block alignment in total knee arthroplasty. Comput Aided Surg. 2012;17(4):205-10. doi: 10.3109/10929088.2012.689335. Epub 2012 Jun 8. |
| 22440228 | Result | Nam D, Nawabi DH, Cross MB, Heyse TJ, Mayman DJ. Accelerometer-based computer navigation for performing the distal femoral resection in total knee arthroplasty. J Arthroplasty. 2012 Oct;27(9):1717-22. doi: 10.1016/j.arth.2012.02.007. Epub 2012 Mar 21. |
| 22032868 | Result | Nam D, Dy CJ, Cross MB, Kang MN, Mayman DJ. Cadaveric results of an accelerometer based, extramedullary navigation system for the tibial resection in total knee arthroplasty. Knee. 2012 Oct;19(5):617-21. doi: 10.1016/j.knee.2011.09.008. Epub 2011 Oct 26. |
| 21397455 | Result | Nam D, Jerabek SA, Haughom B, Cross MB, Reinhardt KR, Mayman DJ. Radiographic analysis of a hand-held surgical navigation system for tibial resection in total knee arthroplasty. J Arthroplasty. 2011 Dec;26(8):1527-33. doi: 10.1016/j.arth.2011.01.012. Epub 2011 Mar 11. |
Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery. Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| KneeAlign System |
Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery. Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty |
|
|
| Secondary | Time Required to Utilize System | The amount of time required to utilize conventional, tibial extramedullary alignment guides versus the KneeAlignTM system, which will be recorded intraoperatively. | Posted | Mean | Standard Deviation | seconds | Minutes during surgery ( Estimated time per surgery 1 hour) |
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| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
| EG001 | KneeAlign System | Digital hand-held surgical navigation system for tibial component placement used by surgeon during surgery. Digital hand-held surgical navigation system: Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty | 0 | 47 | 0 | 47 | 0 | 47 |
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