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Recent advances in total knee arthroplasty (TKA) include an intelligent instrument system designed to provide intraoperative guidance to reduce mechanical alignment errors. Internal position-sensing technology is integrated into microelectronic pods that attach to cutting blocks. The purpose of this prospective, randomized study was to determine whether this iAssist system enables the surgeon to make more accurate bone resections and better restore the mechanical axis compared to conventional instruments in TKA. Patient demographics and preoperative mechanical axis alignments were similar between the groups. Postoperatively, 4.0% of patients had greater than 3° of tibial or femoral component mal-alignment in the guidance-assisted cohort, compared with 36.0% in the conventional group ( P.

Total knee arthroplasty (TKA) is an established technique to improve function and to relieve pain in osteoarthritis x 1 Callahan, M. And Drake, B.G. Tricompartmental total knee replacement. J Am Med Assoc. 1994; 271: 1349–1357 1.

The success of knee arthroplasty depends on achieving the proper ligament balancing and correct component alignment x 2 Sikorski, J.M. Alignment in total knee replacement. J Bone Joint Surg Br. 2008; 90: 1121–1127 , x 3 Stulberg, S.D. How accurate is current TKR instrumentation? Clin Orthop Relat Res.

2003;: 177–184 , x 4 Ritter, M.A., Davis, K.E., Meding, J.B., Pierson, J.L., Berend, M.E., and Malinzak, R.A. The effect of alignment and BMI on failure of total knee replacement. J Bone Joint Surg Am. 2011; 93: 1588–1596 in order to restore optimal function and to guarantee the longevity of the implant x 5 Choong, P.F., Dowsey, M.M., and Stoney, J.D. Does accurate anatomical alignment result in better function and quality of life? Comparing conventional and computer-assisted total knee arthroplasty. 2009; 24: 560–569 , x 6 Sharkey, P.F., Hozack, W.J., Rothman, R.H., Shastri, S., and Jacoby, S.M.

Why are total knee arthroplasties failing today? Clin Orthop Relat Res. 2002;: 7–13.

In a recent study by Ritter et al., it was noted that simultaneous optimal tibial alignment (90° or valgus), femoral alignment (. This was a prospective, randomized study. Male and female patients aged 40-85 years who were indicated for a primary TKA were initially considered for the study. Exclusion criteria included active infection, severe coincident hip arthrosis, neurologic disorders, prior knee arthroplasty or patellectomy, fixed deformity greater than 15°, worker's compensation claims, cancer, metabolic bone disease, osteoporosis/osteopenia (diagnosed or treated with medication), and active immunosuppressive disorder requiring cytotoxic drugs, corticosteroids, or irradiation.

Following institutional review board approval, recruitment took place at the senior author's outpatient arthritis clinic. Without prior published data on iAssist outcomes to allow for a priori power analysis and sample size calculation, the study was designed so that 25 procedures were performed using each technique. For each patient who was indicated for TKA, the above-listed criteria were applied and those who met the inclusion/exclusion criteria were offered enrollment in the study.

Patients were informed by the lead surgeon about the study objectives and the unique features of each technique—TKA using the iAssist surgical guidance system and TKA using conventional instruments. At this time, patients were also reassured that declining to participate would not affect our decision to proceed with surgical intervention. Forty-seven consecutive patients (50 knees) who met the inclusion criteria were offered inclusion in the study; all elected to enroll. Written consent for study participation was obtained from all patients.

To eliminate bias in allocating patients into the study cohorts, an independent author (D. S.) prepared a series of unique numerical identifiers. A computer-generated randomization sequence was then used to assign each identifier into 1 of the 2 cohorts.

After consent for study participation was obtained, each patient was sequentially assigned one of the numerical identifiers and randomized into 1 of the 2 groups. Group I (24 patients, 25 knees) was assigned to undergo TKA assisted by the iAssist surgical guidance system, group II (23 patients, 25 knees) was assigned to undergo TKA using conventional instruments. Demographic data, including age, gender, and body mass index (BMI), were similar between groups ( Table 1). The surgeon (F.

G.) remained blinded to each patient's cohort until the day of surgery; patients were not informed of their study group until completion of the study. A standard TKA was performed through a medial parapatellar arthrotomy. The iAssist does not require pins for optical tracking—as such, no additional incisions were made. Our objective was to position both the femoral and tibial implants at 90° to the mechanical axis and deemed ±3° to be within acceptable alignment in accordance with previous literature x 13 Mason, J.B., Fehring, T.K., Estok, R., Banel, D., and Fahrbach, K.

Meta-analysis of alignment outcomes in computer-assisted total knee arthroplasty surgery. 2007; 22: 1097–1106 13. For the femur, a femoral spike was impacted at the mechanical axis entry point in the distal femur (to within 15° of the mechanical axis in the AP and sagittal planes). The femoral reference pod was attached to the spike and the leg was then moved through a “stop-and-go” star configuration to acquire the hip center and orientation of the mechanical axis. A femoral adjustment pod and cutting guide were then attached to the spike and the cut orientation (flexion/extension and varus/valgus) was modified ( Fig. 1A), with a distal femur cut perpendicular to the mechanical axis planned for all patients. The distal femoral resection guide was then affixed to the distal femur and the spike and sleeve assembly were removed.

The cut was made and a validation pod was used to confirm cut accuracy. A similar process was used for the tibia, with slight variations on conventional extramedullary guide instrumentation. The proximal spike of the extramedullary guide was impacted at the mechanical axis entry point between the tibial spines. The distal portion of the guide consisted of self-centering clamps over the malleoli such that the instrumentation was fixed over the center of the ankle.

The guide was then rotationally oriented to be in line with the medial third of the tibial tubercle and was fixed in place. The leg was then brought into abduction, adduction, and back to neutral to allow the digitizer to register the tibial mechanical axis and transfer it to the pods attached to the tibial resection guide ( Fig. 1B).

The tibial resection guide was then adjusted to correct the coronal alignment and the slope based on iAssist feedback. The depth of the cut was then determined using a classic stylus. Following resection, a validation tool was then used to confirm the cut orientation. Of note, although this validation tool does allow for re-resection if cuts are outside of the acceptable 3°, none of the patients in the study required additional resection following validation. For the conventional group, standard intramedullary femur and extramedullary tibia guides were used. A uniform 5° valgus distal femur cut relative to the intramedullary guide was planned for all patients to eliminate variability.

All patients in both the conventional and navigation groups received cemented, posterior-stabilized Persona components (Zimmer, Warsaw, IN). The demographic data of patients in each cohort are presented in Table 1 and reveals that the 2 groups were similar with respect to gender, age, and BMI at the time of their index procedure. Of note, these values are anecdotally representative of the lead surgeon's average patient population. Lower extremity mechanical axis measurements from preoperative full-length weight-bearing radiographs revealed a mean deviation from neutral of 7.0° (range, 0.1°-16.0°) in the iAssist guidance group and 7.4° (range, 0.1°-20.0°) in the conventional group ( Table 2). No significant difference was appreciated in the preoperative alignment. Table 2 Surgical Outcomes.

Surgical Variable iAssist Guidance Conventional Instruments P Value Postoperative HCT drop 7.3 ± 0.6 6.6 ± 0.5.39 Tourniquet time (min) 113.6 ± 2.5 114.3 ± 3.2.86 Preoperative mechanical axis 6.96° ± 0.90° 7.45° ± 1.12°.74 Postoperative mechanical axis 1.92° ± 0.34° 2.83° ± 0.41°.09 Postoperative femur component alignment 1.65° ± 0.17° 2.23° ± 0.33°.12 Postoperative tibia component alignment 1.28° ± 0.13° 1.71° ± 0.24°.12 Implant alignment Unacceptable: 1 (1 femoral) Acceptable: 24 Unacceptable: 9 (7 femoral, 2 tibial) Acceptable: 16. Surgical blood loss was assessed by evaluating the hematocrit drop from labs drawn preoperatively to results from the morning of postoperative day 1. There was no significant difference in blood loss between groups ( Table 2).

Tourniquet time was not available for 3 patients in the iAssist cohort and 2 patients in the conventional cohort due to an absence of recorded times in the anesthesia record. For the remainder of patients, the average tourniquet time was very similar between the 2 groups ( Table 2). Using component positioning of 90° ± 3° to the mechanical axis as our definition of acceptable implant alignment, 9/25 patients in the conventional group had a femoral or tibial component that was outside of the acceptable range, as compared with 1/25 patients in the iAssist cohort. This represented a statistically significant decrease in the number of outliers present in the guidance-assisted group ( Table 2, P. Regarding the final alignment measurements for each group, there was a trend toward significant improvement with use of iAssist technology for the postoperative femoral mechanical axis, postoperative tibial mechanical axis, and postoperative hip-knee-ankle angle.

This study was not powered to detect a significant difference in improved alignment accuracy. A post hoc power analysis reveals that cohorts of approximately 45 patients would be required to detect a significant difference given the effect sizes measured in our study. Importantly, a statistical comparison of variances for both the postoperative femoral mechanical axis and postoperative tibial mechanical axis using a Bartlett's test reveals that use of iAssist guidance leads to more precise positioning of both components ( P. Postoperative alignment has been shown by multiple authors to affect the longevity of TKA implants x 4 Ritter, M.A., Davis, K.E., Meding, J.B., Pierson, J.L., Berend, M.E., and Malinzak, R.A. The effect of alignment and BMI on failure of total knee replacement. J Bone Joint Surg Am. 2011; 93: 1588–1596 , x 6 Sharkey, P.F., Hozack, W.J., Rothman, R.H., Shastri, S., and Jacoby, S.M.

Why are total knee arthroplasties failing today? Clin Orthop Relat Res. 2002;: 7–13. This study demonstrates that use of a disposable, handheld guidance system in TKA significantly reduces postoperative mechanical axis outliers and decreases alignment variability compared to conventional instruments, without increasing operative time. To our knowledge, this is the first single-surgeon, randomized controlled study comparing this accelerometer-based technology to standard TKA. As reported by Scuderi x 19 Scuderi, G.R.

Total knee arthroplasty performed with inertial navigation within the surgical field. Semin Arthroplasty. 2014; 25: 179–186 19, this new inertial navigation system, the iAssist, proved easy to use. Prior data showed that use of the iAssist system allowed for implant positioning within 1° of the mechanical axis in the coronal and sagittal planes as measured on computed tomography scan. When compared to optical navigation, iAssist was also reliable within 1°.

Although computer-assisted navigation has been shown to reduce the risk of mal-alignment x 13 Mason, J.B., Fehring, T.K., Estok, R., Banel, D., and Fahrbach, K. Meta-analysis of alignment outcomes in computer-assisted total knee arthroplasty surgery. 2007; 22: 1097–1106 13, numerous issues with traditional computer navigation have been reported including increased capital cost and operative times, requirement for placement of additional pins, variation in surgical steps, line-of-sight issues, and the learning curve associated with computer-assisted surgery x 12 Anderson, K.C., Buehler, K.C., and Markel, D.C. Computer assisted navigation in total knee arthroplasty: comparison with conventional methods. 2005; 20: 132–138 , x 16 Carter, R.E., Rush, P.F., Smid, J.A., and Smith, W.L. Experience with computer-assisted navigation for total knee arthroplasty in a community setting.

2008; 23: 707–713 , x 18 Nam, D., Weeks, K.D., Reinhardt, K.R., Nawabi, D.H., Cross, M.B., and Mayman, D.J. Accelerometer-based, portable navigation vs imageless, large-console computer-assisted navigation in total knee arthroplasty. A comparison of radiographic results. 2013; 28: 255–261. Nam et al performed a retrospective review comparing the results of a single surgeon using a large console CAS system and an inertial navigation system. They demonstrated comparable accuracy between a handheld inertial navigation system and large console CAS system.

A follow-up randomized, controlled study looked at tibial component positioning from 5 participating orthopedic surgeons. They found 95.7% of tibial components in the navigation cohort were within 2° of perpendicular to the tibial mechanical axis, vs just 68.1% in the extramedullary cohort x 17 Nam, D., Cody, E.A., Nguyen, J.T., Figgie, M.P., and Mayman, D.J. Extramedullary guides versus portable, accelerometer-based navigation for tibial alignment in total knee arthroplasty: a randomized, controlled trial.

2014; 29: 288–294 17. In their study, navigation was not used to perform the distal femur resection. Our study corroborates these results and confirms that when used for both the femoral and tibial resections, this handheld navigation system reduces the risk of unacceptable component alignment. Although the iAssist system provides a validation tool that allows for confirmation of the cut orientation and the ability to make corrections if cuts are outside of the accepted 3°, we did not need to use this functionality to recut either the femur or the tibia for any of the patients in this study. This speaks to the efficiency and accuracy of the system. However, the ability to confirm cuts and revise as necessary is a useful additional tool, especially in complex cases with significant bony deformity. Another limitation of traditional computer navigation is variation in surgical steps resulting in increased surgical time.

Nam et al x 18 Nam, D., Weeks, K.D., Reinhardt, K.R., Nawabi, D.H., Cross, M.B., and Mayman, D.J. Accelerometer-based, portable navigation vs imageless, large-console computer-assisted navigation in total knee arthroplasty. A comparison of radiographic results.

2013; 28: 255–261 18 compared tourniquet times between an inertial handheld and large console navigation and found tourniquet times to be on average 6 min shorter in the handheld group. In a separate study, this same group reported that the mean time to perform the tibial resection was significantly increased in the inertial navigation cohort vs the conventional cohort. Similarly, Anderson et al x 12 Anderson, K.C., Buehler, K.C., and Markel, D.C. Computer assisted navigation in total knee arthroplasty: comparison with conventional methods. 2005; 20: 132–138 12 noted increased tourniquet times with use of an optically guided, image-free handheld navigation device (Stryker Orthopedics, Mahwah, NJ) when compared to their conventional group (average 90 min vs 75 min, respectively). In contrast to these prior reports, our study showed no significant difference in tourniquet time between the conventional and navigation groups. This result may reflect the minimal alteration in the surgical steps.

The iAssist avoids the need for additional incisions for tracking pins, removes line of site issues, and does not require an infrared camera and large computer console. As we enter the age of bundled payment reimbursement for total joint arthroplasty, one consideration is whether the cost associated with arthroplasty guidance systems precludes their use for routine knee arthroplasty. Longitudinal, long-term studies will be required to analyze the cost-benefit ratio as to whether the improved accuracy with these systems decreases revision rates and supports their use. However, in young patients (where recreation of the mechanical axis is paramount), and in the setting of complex deformity or previously implanted hardware, the clinical benefit of being able to create precise bone cuts and ensure appropriate implant alignment may warrant the additional expenditure.

There are several limitations to this study that must be considered. Although the data collection and analysis process was performed in a blinded manner, it was not feasible to blind the surgeon to each patient's cohort due to inherent differences in surgical technique—this may have introduced surgeon bias into the study. Furthermore, an accurate a priori sample size determination was not achievable, and the study was underpowered to detect differences in tourniquet time or blood loss.

We also did not assess sagittal or rotational alignment outcomes during this study. Each of these variables can significantly affect the performance and longevity of arthroplasty implants, but were beyond the scope of this focused study.

In summary, we have demonstrated that the use of a handheld guidance system in TKA results in decreased mechanical axis variability and a decreased rate of unacceptable postoperative alignment compared to conventional instruments, without resulting in significant increases in operative time or blood loss. This improvement in alignment characteristics with navigation is important, especially in light of new data correlating implant alignment with longevity.