No improvement in reducing outliers in coronal axis alignment with patient-specific instrumentation

Maus, Uwe; Marques, Carlos J.; Scheunemann, David; Lampe, Frank; Lazovic, Djordje; Hommel, Hagen; Vogel, Dennis E.; Haunschild, M.; Pfitzner, Tilman

doi:10.1007/s00167-017-4741-1

Cited by 25 publications

(33 citation statements)

References 37 publications

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“…Promising results for PSI have been initially described in the literature. Within the following years, PSI failed to prove its superiority regarding alignment and clinical outcome compared to conventional methods [36][37][38][39][40]. The results of our study were in line with these observations, similar results concerning the percentage of mTFA outliers had been reported for PSI before [41].…”

Section: Discussionsupporting

confidence: 87%

Accuracy of tibial positioning in the frontal plane: a prospective study comparing conventional and innovative techniques in total knee arthroplasty

Zahn

Graef

Conrad

et al. 2020

Arch Orthop Trauma Surg

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Background Coronal alignment of the tibial component determines functional outcome and survival in total knee arthroplasty (TKA). Innovative techniques for tibial instrumentation have been developed to improve accuracy and reduce the rate of outliers. Methods In a prospective study, 300 patients were allocated to four different groups using a randomization process (two innovative and two conventional) techniques of tibial instrumentation (conventional: extramedullary, intramedullary; innovative: navigation and patient-specific instrumentation (PSI); n = 75 for each group). The aims were to reconstruct the medial proximal tibial angle (MPTA) to 90° and the mechanical tibio-femoral axis (mTFA) to 0°. Both angles were evaluated and compared between all groups three months after the surgery. Patients who presented with a postoperative mTFA > 3° were classified as outliers. Results The navigation and intramedullary technique both demonstrated that they were significantly more precise in reconstructing a neutral mTFA and MPTA compared to the other two techniques. The odd's ratio (OR) for producing outliers was highest for the PSI method (PSI OR = 5.5, p < 0.05; extramedullary positioning OR = 3.7, p > 0.05; intramedullary positioning OR = 1.7, p > 0.05; navigation OR = 0.04, p < 0.05). We could only observe significant differences between pre-and postoperative MPTA in the navigation and intramedullary group. The MPTA showed a significant negative correlation with the mTFA in all groups preoperatively and in the extramedullary, intramedullary and PSI postoperatively. Conclusion The navigation and intramedullary instrumentation provided the precise positioning of the tibial component. Outliers were most common within the PSI and extramedullary technique. Optimal alignment is dependent on the technique of tibial instrumentation and tibial component positioning determines the accuracy in TKA since mTFA correlated with MPTA pre-and postoperatively.

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Section: Discussionsupporting

confidence: 87%

Accuracy of tibial positioning in the frontal plane: a prospective study comparing conventional and innovative techniques in total knee arthroplasty

Zahn

Graef

Conrad

et al. 2020

Arch Orthop Trauma Surg

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“…surgery time, blood loss, transfusion rate) were less likely influenced, since these were perioperatively recorded in medical charts during admission. Six studies in PROM had high risk of attrition bias [42, 51, 53, 58, 68, 71]. In the included studies for the percentage of outliers in the positioning of the prosthetic implants, five studies clearly performed blinding to the outcome assessors for the images, having low risk of outcome detection bias [45, 53, 57, 58, 67].…”

Section: Resultsmentioning

confidence: 99%

“…Fifteen studies were included with various measuring scales and different time points when blood loss was measured postoperatively. In measuring blood loss, 5 studies measured volume of drainage fluid from suction drain device [34, 36, 39, 51, 67], 5 studies measured perioperative hemoglobin reduction [35, 42, 54, 64, 70], 3 studies measured intraoperative bleeding [7, 55, 68], 1 study calculated blood loss using the Mercuriali & Inghilleri formula [53, 76], and 1 study lacked information about the measurement [44]. The time points were most prominently at intraoperative in 3 studies, postoperative 24 h in 3 studies, 48 h in 2 studies, lowest hemoglobin in 1 study, and not shown in 4 studies.…”

Section: Resultsmentioning

confidence: 99%

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Total knee arthroplasty using patient-specific instrumentation for osteoarthritis of the knee: a meta-analysis

Kizaki

Shanmugaraj

Yamashita

et al. 2019

BMC Musculoskelet Disord

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BackgroundTotal knee arthroplasty using patient-specific instrumentation (TKA-PSI), which are disposable cutting block guides generated to fit each patient’s 3-dimensional knee anatomy, has been developed to treat patients with end-stage osteoarthritis of the knee. Surrogate markers such as radiographic malalignment have been well investigated, however, patient-important outcomes are not well examined to elucidate the efficacy of TKA-PSI. The aim of this review is to determine if TKA-PSI improves patient-reported outcome measures (PROM), surgery time, blood loss, transfusion and complications (e.g. surgical site infection, deep venous thrombosis, and revision TKA).MethodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and ongoing clinical trials. For PROMs, surgery time, blood loss, and transfusion rate, we included randomized controlled trials (RCT) comparing TKA-PSI and standard TKA to treat osteoarthritis of the knee. For complications, we also included non-randomized comparative studies (non-RCT).ResultsThis review includes 38 studies, 24 of which were RCT and 14 of which were non-RCT. These included a total of 3487 patients. The predominant population in the included studies highly reflected the general population, with 62% being female, aged over 60 and having end-stage osteoarthritis of the knee. TKA-PSI did not improve PROMs as compared to standard TKA for less than 1-year (mean difference 0.48, 95% confidence interval (CI) -1.92–0.97 in the Oxford knee score, mean 3-month follow-up) and for 1-year or more (mean difference 0.25, 95%CI − 4.39–4.89 in the WOMAC score, mean 29-month follow-up). TKA-PSI did not reduce surgery time (mean difference − 3.09 min, 95%CI -6.73–0.55). TKA-PSI decreased blood loss with a small effect size corresponding to a 0.4 g/dl hemoglobin decrease (95%CI 0.18–0.88), but did not decrease transfusion rate (risk difference − 0.04, 95%CI -0.09–0.01). TKA-PSI did not reduce complication rates (risk difference 0.00, 95%CI − 0.01–0.01 in the composite outcome).ConclusionsTKA-PSI does not improve patient-reported outcome measures, surgery time, and complication rates as compared to standard TKA. TKA-PSI decreases blood loss with a small effect, which is not enough to reduce transfusion rate.

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“…4,5 In some previous reports, PSI improved prosthetic alignment, 21,22 whereas other reports revealed that PSI did not improve prosthetic alignment compared with conventional methods. 23,24 One of the reasons the accuracy of PSI is still debated is that the measurement methods of prosthetic alignment in previous reports were not accurate. Multiple studies assessing the accuracy of PSI have focused on the accuracy of postoperative coronal and sagittal alignments measured via radiography 8 or 2D CT. 12 However, measuring prosthetic alignment using such information has several limitations.…”

Section: Discussionmentioning

confidence: 99%

Prosthetic Accuracy Depends on the Design of Patient-Specific Instrumentation: Results of a Retrospective Study Using Three-Dimensional Imaging

Yamamura¹,

Inori²,

Konishi³

2020

J Knee Surg

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To determine accuracy of patient-specific instrumentation (PSI), the preoperative three-dimensional (3D) plan should be superimposed on the postoperative 3D image to compare prosthetic alignment. We aimed to compare prosthetic alignment on a preoperative 3D computed tomography (CT) plan and postoperative 3D-CT image, and evaluate the accuracy of PSI during total knee arthroplasty (TKA). Thirty consecutive knees (30 patients) who underwent TKA using PSI were retrospectively evaluated. The preoperative plan was prepared using 3D CT acquisitions of the hip, knee, and ankle joints. The postoperative 3D CT image obtained 1 week after surgery was superimposed onto the preoperative 3D plan using computer software. Differences in prosthetic alignment between the preoperative and postoperative images were measured using six parameters: coronal, sagittal, and axial alignments of femoral and tibial prostheses. Differences in prosthetic alignment greater than 3 degrees were considered outliers. Two observers performed all measurements. All parameters were repeatedly measured over a 4-week interval. This measurement method's intraobserver and interobserver reliabilities were more than 0.81 (very good). For the femoral and tibial prostheses, absolute differences between the preoperative and postoperative 3D CT images were significantly larger in the sagittal than in the coronal and axial planes (p < 0.001). The outlier rate for the sagittal alignment of femoral and tibial prostheses was significantly higher than that for the alignment of coronal and axial planes (p < 0.001). However, there were no significant differences in the range of motion (ROM) before and after TKA when comparing cases with and without outliers in the sagittal plane. Even though the present study did not reveal any issues with the ROM that depended on the presence of an outlier, accurate verification of prosthetic alignment for individual PSI models may be necessary because the designs, referenced images, and accuracy are different in each model.

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No improvement in reducing outliers in coronal axis alignment with patient-specific instrumentation

Abstract: Level I, prospective randomized controlled trial.

Cited by 25 publications

References 37 publications

Accuracy of tibial positioning in the frontal plane: a prospective study comparing conventional and innovative techniques in total knee arthroplasty

Accuracy of tibial positioning in the frontal plane: a prospective study comparing conventional and innovative techniques in total knee arthroplasty

Total knee arthroplasty using patient-specific instrumentation for osteoarthritis of the knee: a meta-analysis

Prosthetic Accuracy Depends on the Design of Patient-Specific Instrumentation: Results of a Retrospective Study Using Three-Dimensional Imaging

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