Robotic Assisted TKA May Allow for Smaller Poly Sizes compared to Manual TKA with Simultaneous Removal of Hardware

doi:10.21203/rs.3.rs-4896732/v1

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Robotic Assisted TKA May Allow for Smaller Poly Sizes compared to Manual TKA with Simultaneous Removal of Hardware

https://doi.org/10.21203/rs.3.rs-4896732/v1

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Introduction: TKA after previous hardware around the knee is a challenge to preserve bone while boney landmarks are distorted. Robotic assisted (RA) TKA may assist in simultaneous hardware removal and TKA due to preoperative planning and retention of bone. The aim of this study is to identify if there are differences in component and functional outcomes dependent during simultaneous removal of hardware around the knee and TKA.

Methods: A retrospective chart review was performed on patients undergoing simultaneous ROH and TKA over a 10-year period at a single institution. Patients were required to have at least 6 months of follow up. Data extracted included surgical technique, demographics, range of motion (ROM) at 1 year, complications, need for augments and utilization of revision components.

Results: There were a total of 31 simultaneous ROH and TKA found in the EMR that met inclusion criteria including 23 manual and 8 RA-TKA with ROH. RA-TKA patients had significantly smaller poly sizes (p=0.017). There was a trend for decreased need for augments (p=0.544) and stems (p=0.315) in the RA-TKA group although this was not statistically significant. Postoperative flexion (p=0.973) or extension (p=0.351) at 1 year did not vary. Notably, one patient in the manual revision group required a hinged knee, and one manual patient required an MUA.

Conclusion: Patients undergoing ROH and RA-TKA had a statistically significant decrease in poly size with a trend of less revision component utilization. RA may allow for more boney preservation via CT guided preoperative planning and precise boney cuts.

Intra articular fractures of the distal femur and tibial plateau place patients at an increased risk of developing post traumatic arthritis, Total knee arthroplasty (TKA) serves as the standard of treatment for symptomatic or debilitating post-traumatic arthritis (1, 2). However, complications following TKA after previous open reduction and internal fixation (ORIF) around the knee joint, or other surgery requiring implants, have higher complication rates compared to native primary TKA(3–7). Arthroplasty cases involving hardware are more complicated as they require the decision to retain or remove hardware as well as consideration of larger exposure requirements. Some studies have suggested that retaining hardware may lead to higher rates of complications, specifically mechanical complications(8) while others have found no difference(9). However, all previous studies have looked at removal of hardware utilizing manual total knee arthroplasty with a lack of focus on cases performed with robotic assisted TKA (RA-TKA).

There may be some benefits to RA-TKA in primary and revision arthroplasty as it has demonstrated improved alignment when compared to conventional TKA, (10–12). RA-TKA may have decreased postoperative pain, enhanced early functional status and decreased time to hospital discharge compared to manually preformed TKA(13). Previous concerns of RA-TKA in patients with retained hardware includes obscurity of the preoperative CT scan (required when using systems such as MAKO, and TSOLUTION ONE), making the bony boundaries and details difficult to identify during preoperative planning. However, there has been significant utilization of RA-TKA with preoperative CT planning with successful outcomes in revision and conversion TKA(14–20). We hypothesize that robotic assisted TKA has equivalent outcomes to manual TKA with simultaneous hardware removal and is a safe and effective technique for these patients.

Institutional review board approval was obtained prior to initiation of this study. Patients eligible for this study were identified through a retrospective review of electronic health records for individuals with prior implants undergoing TKA from January 1, 2014, to December 31, 2023, at a single institution by 6 different surgeons. Inclusion criteria were adult patients (18 years old) who underwent a TKA with hardware in the distal femur or proximal tibial with at least 6 months of follow-up. Patients were excluded from the study if they did not meet the above criteria, if there were insufficient notes in the electronic medical record, or had any other procedure done at the time of TKA other than removal of hardware. Manual TKA utilized the Zimmer Biomet Persona® system (Warsaw, IN). RA-TKA were performed with CT-based robotic-assisted technology and utilized Stryker implants (Stryker, Mako, Kalamazoo, MI).

Data collection

All data was compiled and reviewed by the investigators via accessing the patient’s Electronic Medical Record with their Medical Record Number. Data extracted from the patient’s chart included demographics, date of surgery, laterality, and range of motion (ROM.) Surgical data was collected from the operative report including whether surgery was performed manually vs with robotic assist, implant type, poly size, need for augmentation, and utilization of revision components (cones, stems, or sleeves). Complications included any patients requiring manipulation under anesthesia (MUA), having an infection, having a range of motion (ROM) less than 90 degrees at long-term follow-up, or requiring secondary revision surgery. All statistical analysis was conducted in SPSS using the Fisher exact test for nominal variables and two-tailed t-test for continuous variables.

There were a total of 31 simultaneous ROH and TKA found in the EMR that met inclusion criteria. Of those 31, eight were robotic and 23 were manual TKAs. Of the 25 manual TKAs, two were excluded from final analysis because one had an ORIF done at the time of TKA and one had no operative note in the electronic health record.

Average age of all patients was 61.6 +/- 11.6 (P = 0.748) with an average BMI 31 +/- 6.49 (P = 0.210). Eighteen patients (58%) were male (P = 0.412). Average ASA classification was 2.5 +/- 0.5 (P = 0.922). Average length of stay was 67.8 +/- 36.5 hours (P = 0.156). Six patients (12.9%) were diabetic, four patients (12.9%) were smokers, 26 cases (83.9%) had tibial hardware removal, and seven cases (22.6%) had femoral hardware removal. These demographic data are summarized in Table 1.

Table 1

Demographic data for all included patients
	All (n = 31)	Manual (n = 23)	Robotic (n = 8)	P Value
Sex (male)	18 (58%)	15 (65.2%)	3 (37.5%)	0.412
Age (years +/-SD)	61.6 +/- 11.6	62.0 +/- 12.6	60.6 +/- 8.85	0.748
BMI (kg/m2 +/- SD)	31.0 +/- 6.49	29.9 +/- 5.43	34.2 +/- 8.39	0.210
ASA	2.5 +/- 0.51	2.5 +/- 0.51	2.5 +/- 0.53	0.922
LOS (hours +/- SD)	67.8 +/- 36.5	74.8 +/- 30.7	47.75 +/- 46.0	0.156
Diabetes	6 (19.4%)	6 (26.1%)	0 (0%)	0.137
Smoker	4 (12.9%)	4 (17.4%)	0 (0%)	0.281
Follow up (months)	68+/-33	78+/-30	37+/-18	< .001
Tibial Hardware Removal	26 (83.9%)	20 (87.0%)	6 (75%)	0.957
Femoral Hardware Removal	7 (22.6%)	5 (21.7%)	2 (24%)	0.792

Of all 31 TKAs, 20 (64.5%) had cemented components (P = 0.095), two (6.45%) had augments (P = 0.544) both of which were tibial augments, 12 (38.7%) had stemmed components (P = 0.017) all of which had tibial stems, two (6.45%) had femoral stems (P = 0.544), and one (3.22%) had hinged component (P = 0.742) (Table 2). Polyethylene size had a mean of 11.9 +/- 2.60 mm (P = 0.017) with robotic TKAs having a significantly smaller polyethylene size. Of the 31 TKAs, 13 (41.9%) had CR implants (P = 0.0002) with robotic TKAs having a significantly higher proportion of CR components. These data are summarized in Table 2.

Table 2

Implant data for all patients. Significant data between the manual and robotic groups are in bold.
	All (n = 31)	Manual (n = 23)	Robotic (n = 8)	P Value
Cement	20 (64.5%)	18 (78.3%)	2 (25%)	0.095
Augments	2 (6.45%)	2 (8.70%)	0 (0%)	0.544
Tibial augments	2 (6.45%)	2 (8.70%)	0 (0%)	0.544
Femur augments	0 (0%)	0 (0%)	0 (0%)	1
Size of poly (mm +/- SD)	11.9 +/- 2.60	12.2 +/- 2.48	10.2 +/- 1.64	0.017
Need for Stems	12 (38.7%)	10 (43.5%)	2 (25%)	0.315
Femoral stem	2 (6.45%)	2 (8.70%)	0 (0%)	0.544
Tibial stem	12 (38.7%)	10 (43.5%)	2 (25%)	0.315
Hinged implant	1 (3.22%)	1 (4.35%)	0 (0%)	0.742
CR implant	13 (41.9%)	5 (21.7%)	8 (100%)	0.000163

In the postoperative followup, of all 31 TKAs, there was one (3.22%) complication which was in the manual group, comprised arthrofibrosis, and was managed by MUA. There were no revisions among all patients. Mean range of motion was 117.8 +/- 11.4 degrees (P = 0.927), mean extension was 0.17 +/- 0.91 degrees (P = 0.351), and mean flexion was 118 +/- 11.4 degrees (P = 0.973). These data are summarized in Table 3.

Table 3

Postoperative data for all patients.
	All (n = 31)	Manual (n = 25)	Robotic (n = 8)	P Value
Complications	1 (3.22%)	1 (4.35%)	0 (0%)	0.742
MUA	1 (3.22%)	1 (4.35%)	0 (0%)	0.742
Need for Revision	0 (0%)	0 (0%)	0 (0%)	1
Range of motion at 1 year (degrees +/- SD)	117.8 +/- 11.4	117.5 +/- 11.5	118 +/- 12.0	0.927
Extension at 1 year (degrees +/- SD)	0.17 +/- 0.91	0 +/- 0	0.63 +/- 1.77	0.351
Flexion at 1 year (degrees +/- SD)	118 +/- 11.4	117.95 +/- 11.5	118.125 +/- 11.9	0.973

Patients with retained hardware around the knee joint are more likely to develop arthritis and, in that case, may require a removal of some or all of the hardware to allow for proper positioning of the implants, making TKA more difficult. The decision to remove vs. retain hardware in a staged or simultaneous procedure may be a challenging clinical decision to make. Robotic assisted TKA has not been utilized previously for patients with retained hardware requiring a simultaneous ROH and TKA. Benefits include not only being able to accurately position the implants around the retained hardware, but to pre-operatively plan whether some or all of the hardware even needs to be removed. While there are concerns that CT preoperative planning may be obscured due to hardware, there have been several studies showing successful surgery with prior UKA, PFA or TKA (14–20). The successful outcomes of RA-TKA with prior hardware further supports CT guided RA-TKA with hardware around the knee is feasible.

In this study, RA-TKA allowed for significantly smaller poly sizes and a trend towards fewer cases requiring revision components for adequate fixation. These results suggest that RA may allow for less bony resection in these areas with previous hardware while balancing the knee. CT guided preoperative and intraoperative planning may in fact allow for more bone retention as the location of the ORIF hardware is precisely known. These results are similar to Yun et al. (15) who found robotic assisted conversion of UKA to TKA required significantly fewer augments, fewer revision components and a non-significant decrease in polyethylene thickness compared to manual conversion. Notably this was not replicated in a similar study by Lachance et al.(19) comparing robotic vs. manual conversion UKA to TKA. As thicker polyethylene sizes are associated with increased poly wear and need for revision(21, 22), the use of robotic assistance to predictably place smaller polyethylene components may benefit patients in long term follow up.

One concern for concurrent ROH and TKA is bone loss from the ROH, which may require increased fixation methods including stems and augments. In this series, there were no patients with early loosening, suggesting good fixation with primary and revision components. While not statistically, significant, there were more patients in the manual TKA group requiring stemmed implants, augments and cementation. Stemmed components may provide some benefit for patients after ROH through increased stability and reduced micromotion at the bone-implant interface, especially in patients with bone loss from prior hardware (23, 24). Stems are commonly used as a means to try to reduce tibial loosening in patients at high risk of this complication(25). However, if a patient already has a stem and revision is required for loosening or infection, there may be decreased bone stock in the subsequent surgery, making revision more difficult and requiring longer stemmed implants(26). Patients may also suffer from stem tip pain and have a higher risk for fracture around the stem(27, 28). When compared to shorter stems, long stems have increased stress shielding on the the surrounding bone. (29), (30, 31). Utilization of stems in a primary TKA also increases cost of surgical intervention(25). These findings suggest there may be some clinical benefit in utilizing RA-TKA for patients with previous hardware around the knee. Our study is likely underpowered to detect a true statistical significance due to the rarity of the case.

Between manual and RA-TKA, similar range of motion was seen postoperatively at one year. One patient in the manual TKA group with limited ROM required an MUA which did not result in significantly improved function. ROM has been a problem with hardware around the knee(32) likely secondary to scarring and thickening of the joint capsule and previous injury around the knee. The goal of postoperative ROM is generally around 110 degrees of flexion for symmetrical stair gait (33), which was reached by all but one patient in the RA-TKA group and two manual patients. Several studies have shown improved ROM in RA-TKA when compared to manual TKA(34, 35). RA-TKA has been found to have a reduction in the early postoperative local inflammatory response and pains scores (36). In theory, decreased pain and inflammation is thought to lead to faster recovery and shorter length of stay(37, 38). Notably, robotic patients were able to be discharged at 48 vs. 75 hours, suggesting potentially better early recovery directly after surgery, although there are a plethora of patient factors affecting this. Further study is required to determine differences in ROM for manual vs. robotic TKA in patients with ROH.

At one-year post-op, no patients in either group had a significant complication requiring revision surgery. However, our study was underpowered to pick up differences in infection risk. A recent retrospective review by Baker et al. evaluated a total of 16,099 cases and found a statistically significant increase in prosthetic joint infection in patients undergoing concomitant removal of hardware and TKA compared to staged removal of hardware, at 3 months and 1-year post-op, with an infection rate of 3.95% in the concomitant group at 1-year[39]. It was also found that patients who had their ROH performed greater than three months prior to their TKA had a decreased risk of infection. Interestingly, another study demonstrated that concomitant ROH and TKA is more likely to be done through one incision whereas staged ROH and TKA is likely to be done through multiple incisions(39). Despite the theoretical risk of infection or wound complications with multiple incisions, there was no difference in the rate of reoperation, complication, or revision between the concomitant or staged groups. While there may be a decreased infection rate in staged ROH and TKA, for select patients wishing or who may be better served by one surgery, our data suggests a similar rate of infection between RA-TKA and manual. These findings are limited by our small sample size.

Notable limitations include the significant heterogeneity in the type of retained hardware that was in place about the knee prior to TKA. Most notably, there was no standardization for patients that had all their retained hardware removed or had some hardware retained. In addition, different preoperative hardware may change how much bone is able to be retained vs. resected. The sample size is limited to the unique nature of patients with previous hardware prior to TKA. Surgeries were performed by six different surgeons which may slightly change instrumentation utilized. Range of motion was performed by several practitioners which is also an additional variable. Additionally, long term follow up is required to make definitive claims.

Taken together, our results suggest that simultaneous removal of hardware with TKA is a safe and effective procedure. RA-TKA may allow for the use of smaller polyethylene sizes with a decreased need for revision components, suggesting improved bone preservation. Similar range of motion and revision rates were documented at 1 year. Longer term outcomes are required to determine the efficacy and safety of RA vs. manual TKA with simultaneous hardware removal.

Author Contribution

A.L, A.E and S.S. wrote the mansucriptS.S. prepared the statistics and collected dataR.S. editted the manuscriptM.S. and J.L. were responsible for the creation of the projectAll authors reviewed the manuscript

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Tables 1 to 3 are available in the Supplementary Files section

No competing interests reported.

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You are reading this latest preprint version

Robotic Assisted TKA May Allow for Smaller Poly Sizes compared to Manual TKA with Simultaneous Removal of Hardware

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Abstract

Introduction

Methods

Data collection

Results

Discussion

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Author Contribution

References

Tables

Additional Declarations

Supplementary Files

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