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Abstract

Aim:

Given recent concerns regarding the influence of different cements and implants on the rate of aseptic failures in total knee arthroplasty (TKA), we wondered if cementation technique could play a role. The primary aim of this review was to collect and compare the surgeon education materials from eight orthopedic implant manufacturers to evaluate the manufacturers’ recommended cementation technique in TKA and identify if there was any consistency in these readily available guides as to the best practices of cementation of their implants.

Materials and Methods:

We reviewed contemporary surgeon education guidelines for all TKA systems available from eight manufacturers. Variables included: cement type, batches prepared, surface preparation prior to application, cleaning and/or drying the bone surface, mixing the cement, the waiting phase after the cement has been mixed prior to application, pressurizing the cement, location of cement application, and the curing time. Data were recorded and organized for qualitative comparisons.

Results:

We identified a total of 43 guides covering 38 implants from eight different manufacturers. There were 41 surgical technique guides and two general brochures regarding cementation techniques available from the manufacturers. Even within the manufacturers’ own guidelines for the different implants, there was a wide variety of differing guidelines on many aspects of the cementation technique.

Conclusion:

Keywords

aseptic loosening cementation consensus tibial baseplates total knee arthroplasty

Introduction

Although total knee arthroplasty (TKA) has historically been an extremely successful operation, the number of revision surgeries is expected to continue to increase over time. Thus, it is essential to understand why TKA operations fail and to take all possible measures to reduce the incidence of failure. Several mechanisms of TKA failure have been identified, with infection and aseptic loosening being among the most common reasons.¹ Recent concerns have been raised regarding the influence of different cements, including high versus low cement viscosity, antibiotic versus nonantibiotic cement, hand mixed versus commercially mixed antibiotics, bowl mixed versus vacuum mixed cement, full versus partially coated implants, as well as implant design and implant materials in the role of aseptic failures in TKA.^2

–8 Many studies that look at implant survivorship come from case series, databases, or registries. One factor that has been less discussed includes potential variability in surgical cementation technique.^4,9,10 While most retrospective reviews and registry level data may be able to look at the implants, cements, or supplies used during high volumes of surgeries, the actual surgical technique of how cement is applied and utilized is not often captured or analyzed. While there may be many factors that influence a surgeon’s technique, including their training and experience, one source of information that could provide recommendations and is readily available to all surgeons using a particular implant includes the implant manufacturers’ technique guides.

Variations exist in the surgical technique that surgeons use to cement the tibial and femoral components during TKA. In vitro testing has shown that key variables such as time of cement application, cementation of the stem and tray surfaces, cement phase, cement being applied to clean and dry surfaces of just the implants, just the prepared bone surfaces, or both, and cement penetration all have vital roles in influencing the implant–cement interface bonding.^2,4,9

–12 Given the increased concern around aseptic TKA failures and variations in cementation technique, we wondered if there was standardization in the recommendations from implant manufacturers regarding best practice cementation of their implants. While we understand full well that surgeons may not have their practice influenced by the industry-published literature, reviewing this at least serves as a starting point for us to understand if there is any currently published source of possible consensus or best practices.

The purpose of this review was to collect and compare the surgeon education materials for the most popular implants from eight orthopedic implant manufacturers to assess the manufacturers’ recommended cementation technique in TKA.

Materials and methods

We systematically reviewed contemporary surgeon education guidelines for total knee systems available in their respective libraries from the following manufacturers: Zimmer Biomet (Warsaw, Indiana, USA), DePuy Synthes (Warsaw, Indiana, USA), Stryker (Kalamazoo, Michigan, USA), Smith & Nephew (Memphis, Tennessee, USA), Aesculap (Center Valley, Pennsylvania, USA), Ortho Development Corporation (Draper, Utah, USA), Medacta International (Castel San Pietro, Switzerland), and Conformis (Billerica, Massachusetts, USA). Based on global sales from 2017, we identified Zimmer Biomet, Depuy Synthes, Stryker, and Smith & Nephew as the four largest orthopedic implant manufacturers.¹³ After these four manufacturers, the total combination of all “other companies” sales slightly exceeded the sales of the fourth largest company. To capture guidelines outside of the four major manufacturers, we also included the review of surgical guidelines for knee implant systems from Aesculap, Ortho Development, Medacta International, and Conformis. We identified a total of 43 guides covering 38 implants from eight different manufacturers (Figure 1). They consisted of 41 surgical technique guides and 2 general brochures regarding cementation techniques provided by the manufacturers.

Figure 1.

Inclusion criteria flow diagram.

All text, figures, and graphics related to cementation technique (both preparation and application) in the surgeon education guidelines for each total knee system were evaluated. Techniques for only the tibial component were included, given the overall lack of descriptiveness for technique regarding the femoral or patellar components in our initial review. The variables of interest included cement type, batches prepared, surface preparation prior to application, cleaning and/or drying the bone surface, mixing the cement, the waiting phase after the cement has been mixed prior to application, pressurizing the cement, location of cement application, and the curing time.

Data were recorded and organized for comparison both within and between individual manufacturers. Qualitative comparisons are reported.

Results

Both the surgical technique guides and the cementation brochures lacked uniformity in regard to the variables of interest analyzed (Tables 1 to 8). Further, as mentioned, there was a lack of description of the technique for components other than the tibial tray, and thus, we organized the systematic description of techniques around just the tibial component.

Table 1.

Zimmer Biomet cementation guidelines.

Implant	Cement type	Batches, n	Surface prep	Cleaning	Mixed with vacuum	Waiting phase after mixing	Pressurized	Cement to implant	Cement to bone	Curing time
N/A	PMMA PALACOS	N/A	Perforate cancellous bone if dense or sclerotic	Pulse lavage followed by clean /dry bed	ClearMix™	Early as possible, no waiting phase	Knee flat nozzle, 23° pressurizing nozzle, or knee cementation nozzle on a bone cement gun	Implant first (including keel and underside of tibial tray)	Tibial stem hole	N/A
Persona the personalized knee	N/A	2	Drill multiple holes if sclerotic bone	Pulse lavage	Mix cement following manufacturer’s guidelines	Follow guidelines of cement manufacturer	N/A	Tibial baseplate and keel; femoral underside	Resected surfaces, holes, and tibial IM canal	Fully cured before trial implants
Gender Solutions Natural-Knee	Methyl- methacrylate	N/A	N/A	N/A	N/A	N/A	Impact tibial baseplate onto tibial surface, “pressurizing” the cement	3–4 mm underside of tibial component	N/A	N/A
Gender Solutions NexGen high-flex knee^a	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Zimmer NexGen LPS-flex mobile and LPS mobile bearing knees	N/A	N/A	N/A	N/A	N/A	Doughy consistency	N/A	Underside of tibial baseplate and around the keel	Resected tibial surface and on the IM canal	Completely cure
NexGen complete knee solution LPS-flex fixed bearing knee	N/A	N/A	N/A	N/A	N/A	N/A	N/A	Underside of tibial plate and around the keel	Resected tibial surface and in the tibial IM canal	Completely cure
Zimmer Gender Solutions PFJ system	N/A	N/A	N/A	N/A	N/A	N/A	Apply pressure on implant until cement is cured	Undersurface of PMJ implant and/or femur as appropriate	Undersurface of PMJ implant and/or femur as appropriate	Apply pressure on implant until cement is cured
Signature personalized patient care	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Vanguard complete knee system	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Vanguard ID total knee	N/A	1	Perforate cancellous bone on the tibial side by drilling /punching array of 2 mm holes, 3-4 mm deep, spaced 5-8 mm apart	Pulse lavage followed by drying with a lap sponge	Vacuum mixing cartridge	As soon as cement properties permit	Cement gun/cartridge w/pressurizing nozzle or cement may be applied manually and pressed forcefully into the bone using ½ inch or wider flat osteotome	Thin layer over underside of tibial component, just overfilling the pockets on underside of tray up to 1 mm proud posteriorly and 2 mm anteriorly	Tibia w/pressurizing, striving for 3-5 mm penetration	N/A

IM: intramedullary; PFJ: patello-femoral joint.

^a Although we did not find any surgical technique guide that addressed cementation for this implant, the brochure states that this implant can be implanted using any Zimmer surgical technique including Zimmer^® Minimally Invasive Solutions™ (MIS™) procedures.

Table 2.

Depuy Synthes cementation guidelines.

Implant	Cement type	Batches, n	Surface prep	Cleaning	Mixed with vacuum	Waiting phase after mixing	Pressurized	Cement to implant	Cement to bone	Curing time
N/A	N/A	2	Drilling /keying holes in dense or sclerotic area	Pulsatile lavage followed by drying	N/A	Apply early in dough state	May be syringed under pressure by seating nozzle directly onto the cut bone surface; in dough state, MV and HV cement may be pressurized digitally or by hand into the bone surface; extend leg after implantation. May also be pressurized digitally.	MV cement applied after dough state is reached	MV cement poured both before and after dough state	N/A
Sigma primary knee system	SMARTSET® HV Bone Cement or MV Bone Cement	N/A	Drilling holes in bone	Pulsatile lavage	SMARTMIX® Vacuum Mixing Bowl or the SMARTMIX CEMVAC® Cement System	Choose cement which reaches its working phase early	When fully inserted, several mallet blows may be delivered to the top of the tray inserter	Thick layer to either on the bone or on the implant	Either on the bone or on the implant	N/A
Attune knee system	Choose cement that reaches its working phase quickly	N/A	Drilling holes in bone	Pulsatile lavage followed by drying	N/A	Choose cement that reaches its working phase quickly; If applying to both implant and bone, cement should be in dough state	When inserted, impact tibial base with several blows from the Mallet to the top of the ATTUNE System impactor to pressurize cement; extend leg after implantation	Thick layer to bone, implant, or both	Thick layer to bone, implant, or both	Fully cure before trial implants
LCS complete knee system	Choose cement that reaches its working phase quickly	N/A	Drilling holes in bone	Pulsatile lavage followed by drying	N/A	Choose cement that reaches its working phase quickly; If applying to both implant and bone, cement should be in dough state	When inserted, several mallet blows may be delivered to the top of the tray inserter	Thick layer to bone, implant, or both	Thick layer to bone, implant, or both	N/A
AOX PE	PE option	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A

MV: medium viscosity; HV: high viscosity.

Table 3.

Stryker cementation guidelines.

Implant	Cement type	Batches, n	Surface prep	Cleaning	Mixed with vacuum	Waiting phase after mixing	Pressurized	Cement to implant	Cement to bone	Curing time
Triathlon total knee system	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Scorpio NRG	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Scorpio single axis	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Triathlon PKR	N/A	N/A	N/A	N/A	N/A	N/A	Press cement into bone of tibia; extend leg after implantation; a thin spacer may be inserted for additional pressurization	Implant surface and side wall of component	Tibial surface and wall of tibial eminence	N/A
AVON patello-femoral	N/A	N/A	N/A	N/A	N/A	N/A	Cement gun	N/A	Anterior femoral surface and patella	N/A

Table 4.

Smith & Nephew cementation guidelines.

Implant	Cement type	Batches, n	Surface prep	Cleaning	Mixed with vacuum	Waiting phase after mixing	Pressurized	Cement to implant	Cement to bone	Curing time
Legion CR, AS, and PS	N/A	N/A	N/A	N/A	N/A	N/A	After implantation, place tibial insert trial onto tibial implant and extend leg	Apply to implant or prepared bone based on surgeon’s preference	Apply to implant or prepared bone based on surgeon’s preference	N/A
GENESIS⋄ II total knee	N/A	N/A	N/A	N/A	N/A	N/A	After implantation, place tibial insert trial onto tibial implant and extend leg	Proximal tibia and/or the implant	Proximal tibia and/or the implant	N/A
LEGION RK revision knee	N/A	N/A	N/A	N/A	N/A	N/A	Place the correct size tibial insert trial into the tibial baseplate and extend leg	N/A	Proximal tibia; distal surface of femur	N/A
LEGION HK hinge knee system	N/A	N/A	N/A	N/A	N/A	N/A	Place the correct size guided motion tibial insert trial into the tibial baseplate and extend leg	N/A	Proximal tibia	N/A

Table 5.

Aesculap cementation guidelines.^a

Implant	Cement type	Batches, n	Surface prep	Cleaning	Mixed with vacuum	Waiting phase after mixing	Pressurized	Cement to implant	Cement to bone	Curing time
Vega System	N/A	N/A	N/A	Bone facets carefully cleansed and rinsed	Follow directions provided by cement supplier	Follow directions provided by cement supplier	Follow directions provided by cement supplier	N/A	N/A	N/A
Columbus Knee System	N/A	N/A	N/A	N/A	N/A	N/A	N/A	Implants may be implanted with or without cement as desired—the surgeon makes this decision according to the bone quality of the patient	N/A	N/A
Advanced surface technology	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
MIOS	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Univation X	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Columbus AS revision knee system	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
EnduRo AS knee revision system	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A

^a We were unable to secure a copy of the surgical technique guides for the implants to review, although the implant manuals refer to it and say that it is available on request.

Table 6.

Ortho Development cementation guidelines.

Implant	Cement type	Batches, n	Surface prep	Cleaning	Mixed with vacuum	Waiting phase after mixing	Pressurized	Cement to implant	Cement to bone	Curing time
Balanced knee system	N/A	N/A	Plug entry hole to the femoral medullary canal with a cancellous bone plug from either the resected notch from a PS femur or the resected chamfer cuts from a CR femur	Pulse lavage	N/A	N/A	Apply cement by firm thumb pressure to proximal tibia; use firm pressure to ensure cement interdigitation into bony interstices	Tibial keel recesses	Proximal tibia	Allow cement to fully cure before removal of tibial insert trial
BKS TriMax	N/A	N/A	Entry hole to femoral medullary canal may be filled with a cancellous bone plug from either the resected notch from a PS femur or the resected chamfer cuts from a CR femur	Pulse lavage	N/A	N/A	Use firm pressure to ensure cement interdigitation into bony interstices	Tibial keel recess	Proximal tibia	Allow cement to fully cure before removal of tibial insert trial
Balanced knee revision system	N/A	N/A	N/A	Pulse lavage	N/A	N/A	Cement restrictor may be inserted into medullary canal to allow proper pressurization of cement; use a mallet and the tibial impactor to securely seat the implant and pressurize the cement	Proximal tibial surface or underside of implant	Proximal tibial surface or underside of implant	Cement cures after trial implants have been inserted and before final trial reduction

PS: posterior stabilized; CR: cruciate retaining.

Table 7.

Medacta International cementation guidelines.

Implant	Cement type	Batches, n	Surface prep	Cleaning	Mixed with vacuum	Waiting phase after mixing	Pressurized	Cement to implant	Cement to bone	Curing time
GMK sphere	N/A	Follow instructions from cement manufacturer	N/A	N/A	Follow instructions from cement manufacturer	Follow instructions from cement manufacturer	N/A	Undersurface of tibial implant into corresponding cement pockets and not around keel	If applied directly to bone, ensure it does not enter keel hole	Follow instructions from cement manufacturer
GMK primary	N/A	Follow instructions from cement manufacturer	N/A	N/A	Follow instructions from cement manufacturer	Follow instructions from cement manufacturer	N/A	Tibial baseplate—no cement surrounding keel	No	Follow instructions from cement manufacturer

Table 8.

Conformis cementation guidelines.

Implant	Cement type	Batches, n	Surface prep	Cleaning	Mixed with vacuum	Waiting phase after mixing	Pressurized	Cement to implant	Cement to bone	Curing time
iTotal PS	N/A	N/A	N/A	Thoroughly wash (using pulse lavage if available) and dry bone	N/A	N/A	N/A	Thin layer of cement to tibial tray	Thin layer of cement to tibia	N/A
iTotal CR	N/A	N/A	N/A	Thoroughly wash (using pulse lavage if available) and dry bone	N/A	N/A	N/A	Tibial tray	Tibia, filling holes and covering bone surface	N/A
iUni	N/A	N/A	Drill 8–10 cement holes	Irrigate joint	N/A	N/A	Press down such that excess cement extrudes anteriorly;	N/A	Tibia, filling holes and covering bone surface	N/A
iDuo	N/A	N/A	Drill 12–15 cement holes	Irrigate joint	N/A	N/A	Press down such that excess cement extrudes anteriorly;	N/A	Tibia, filling holes and covering bone surface	N/A

Six implants lacked guides with any information on cementation technique. Ultimately, only 5 implants had guides that addressed the type of cement to be used, 2 implants had guides that addressed the number of suggested cement batches, surface preparation prior to cementation was provided for nine implants, 13 had guides that addressed cleaning and/or drying the bone surface, 6 had guides that addressed mixing the cement, 9 had guides that addressed the waiting phase after the cement has been mixed, 32 had guides that addressed pressurization of the cement, 24 had guides that addressed location of the cement application, and 10 had guides that addressed the curing of the cement.

The majority of information available was regarding pressurization and cement placement. Thirty-one implants had guides that addressed pressurization of the cement. Ultimately, two main types of pressurization were described including the use of a mechanical device versus manual pressurization. Mechanical devices included the use of a cement gun (3) or a syringe (1). Manual pressurization techniques included extending the leg after implantation with a spacer (8), using mallet blows (4), using a tibial impactor (29), or “other” manual means including digital impaction (10). One guide discussed the use of a restrictor to aid in pressurization. The majority of guides suggested multiple means of pressurization.

Twenty-four implants had guides that addressed cement location, either on the implant (22) and/or on the bone (24). Cement location on the implant varied from the general underside of the baseplate (6/22), a specific location on the underside of the baseplate (2/22), the tibial tray (2/22), the surface of the implant (1/22), the sidewall of the implant (1/22), the keel (3/22), and the keel recesses (2/22). Seven implants had guides that directed the surgeon to apply cement to the implant but lacked more specific instructions. Seven implants had guides that stated that it is optional to put cement on the implant, with four specifically stating that it is based on the surgeon’s preference. The locations of cement application on the bone were also inconsistent with locations including the general bone (7/24), general bone with specific cement penetration dimensions (1/24), resected surface holes (4/24), resected tibial surface (6/24), wall of tibial eminence (1/24), tibial intramedullary canal (3/24), and the proximal tibia (6/26). Five implants had guides, which stated that it is optional to put cement on the bone, and three implants had guides, which indicated that the application of cement to the bone was based on the surgeon’s preference.

Notably, the cement type, batches prepared, mixing the cement, the waiting phase after the cement has been mixed prior to application, and curing time all lacked consistency in the published guides.

It is of particular interest that both the surface preparation and cleaning of the bony surfaces were also very limited in information as these are thought to be very important variables in cementation technique. Nine implants had guides that addressed surface preparation before cementation. While most implants (7/9) had guides that recommended drilling holes into the bone to improve cement interdigitation, only two of them specified how many holes to drill, and only one specified the exact dimensions of how big, deep, and how spaced apart the holes should be. Thirteen implants had guides that suggested cleaning the bone before cement application. Most of those that suggested cleaning specifically recommended pulse lavage (10/13), but only five directed the surgeon to dry the bone after cleaning.

Even within the manufacturers’ own guidelines for the different implants that they provided, there was a wide variety of differing guidelines on many aspects of the cementation technique (Tables 1 to 8). Finally, it should be noted that tibial impaction was not included in the data tables under the pressurization column as it was found in 29/31 implants reviewed.

Discussion

This study confirms our suspicion that currently available orthopedic implant manufacturer product literature lacks consistency in recommended cementation techniques for TKA. There was a wide variety of differing and inconsistent guidelines in surgeon education material both within and between manufacturers with no clear consensus of best practice. Given that aseptic loosening remains among the top two most common causes for failure in TKA, it is possible that the underlying causes relating to this failure should be further understood.¹ Infection has been identified as the primary reason for revision with rates generally ranging from 25% to 36% of all revisions, whereas aseptic loosening generally comprises 18–27% of revisions.^14
–16 There has been, and continues to be, a great deal of orthopedic research dedicated toward understanding and lowering infection rates following TKA through patient optimization, efficient surgery, controlling intraoperative conditions, and decreasing postoperative complications.^17,18 Reasons for aseptic loosening, however, are not completely understood and are likely multifactorial in nature but may have room for additional investigation. This includes inquiring about best practices in cementation technique. Etiologies for TKA aseptic failure have included polyethylene wear with subsequent osteolysis, postoperative alignment, and body mass index (BMI).^{8,19

–25} As implant design and polyethylene production have improved, we have seen a decline in failure due to polyethylene wear and subsequent osteolysis.^26,27 As such, other factors of implant fixation that have gained recent scrutiny and include factors related to the cement or implant include: (1) implant selection with considerations for surface roughness,²⁸ implant material,^28,29 implant pattern,²⁸ and placement;^24,30 (2) surface preparation including perforation of sclerotic bone^3,31 and pulsed lavage^32
–34; (3) viscosity of the cement^6,11,35; and (4) cementation technique^4,7,9,34,36 to include the set phase,⁹ penetration, and coverage^7,36 (surface, bisurface, or fully cemented keels). The recognition that cementation technique is a potential contributing factor to aseptic loosening may be of importance, particularly if there is a lack of consensus on best practice, standardization in technique, and documentation thereof. Given that registry or database studies often look at implant, cement, or supplies, these studies may not be able to detect the influence of technique on outcomes or survivorship.³⁷

Implant design and materials may be a contributing factor in aseptic cemented TKA failures. Pittman et al.²⁸ found that metal–cement interface strength generally increases with increasing surface roughness, showing that the type of metal substrate and surface preparation of contemporary tibial baseplates may influence the strength of the metal–cement interface. They reported that almost all of the surface finishes attained stronger bonds with cement when the sample prostheses were constructed from titanium bar stock (as opposed to cobalt-chrome). They also found that a macrosurfaced implant may be more vulnerable to rotational forces, which may be partially responsible for the failures with associated implant-cement debonding reported by Mikulak et al.²⁹ with the press-fit condylar modular total knee prosthesis. Finally, some reports have suggested that implant placement, specifically a mechanical alignment error more than 3°, increases the risk for aseptic loosening and that this alignment error is amplified in patients with an increased BMI.^24,30

Drilling or perforation of the sclerotic bone should be performed prior to pulsed lavage to allow for complete removal of the bone debris.³ Perforation of the sclerotic bone has been shown to improve cement penetration and decrease radiolucent lines at 1- and 2-year follow-up when larger diameter (4.5 mm) bits are used.³¹ Final preparation of the bone–cement interface is best performed using pulsed lavage. In separate studies, Schlegel et al.^32,33 confirmed the importance of bone preparation and pulsed lavage in enhancing fixation strength and recommended that it is a mandatory step in surface preparation along with copious drying of the tibial surface when cementing tibial components in TKA.

Cement viscosity is another factor that has gained recent attention, particularly as high viscosity cement (HVC) has seen increasing utilization.⁵ Cement viscosity contributing to TKA loosening was brought to attention by Kopinski et al.³⁵ when they detailed a case series that showed the association between the use of HVC and debonding of the tibial implant–cement interface. Kopec et al.⁶ found evidence to support this claim in a study, where cement penetration into the tibial plateau was significantly reduced with the use of HVC. Conversely, Crawford et al.¹¹ showed that HVC and a standard 40-mm I-beam tibial tray has a very low incidence of tibial aseptic loosening even in a high-risk group of obese patients. It is also interesting to note that the percentage of TKAs performed using HVC has steadily increased over the most recent 7 years for which the American Joint Replacement Registry has data.⁵ While Kopinski et al.³⁵ proposed a potential for tibial baseplate debonding with the use of HVC, they noted several limitations to their case series. Primarily, they note that due to all of the procedures occurring elsewhere, they (1) lacked the ability to provide a description of the baseplate material (e.g. cobalt chromium vs. titanium baseplates) and (2) are unable to describe the surgical technique (e.g. how was the cement mixed, was cement applied to the implant and prepared bone, or one or the other). The findings in their publication may need to be reassessed with all of these factors accounted for.

There are several factors associated with the preparation and application of the cement itself, including the set phase of the cement. Silverman et al.⁹ compared cement penetration of different cement phases in TKA and found that cement penetration was greatest in the dough phase. They suggest that this application of the cement in this set phase may decrease the likelihood of aseptic loosening. When considering the surface location of the cement, a cadaveric study performed by Peters et al.⁷ found no difference in micromotion between surface cementing TKA and fully cemented TKA and suggest that this may be due to the cement penetration of 3–5 mm in both groups. Using a sawbone model, Vanlommel et al.³⁸ concluded that a penetration depth of 3–5 mm is optimal and recommended bisurface application of cement on the underside of the tibial baseplate as well as on the cut surface of the proximal tibia using digital impaction or impaction with a spatula. Pelt et al.³⁴ confirmed adequate results of implant stability using a surface cementation technique of the tibial component (as compared to the fully cemented keel technique). Finally, Han et al.⁴ found that pressurizing and using a bisurface cementation technique significantly reduce the occurrence of early loosening around the femoral component. They claim that this is due to the paramount importance of the initial fixation of cement. Interestingly, Galasso et al.³⁶ suggest that cementing the keel had no additional advantage for fixation.

When evaluating our own series of TKA patients from 2003 to 2008, we identified only 4/468 (<1%) TKA cases with aseptic loosening.³⁹ Similarly, when assessing those with the only surface cementing of the tibial baseplate, we reported <1% aseptic loosening rates at a minimum 5-year follow-up.⁷ Our cementation technique remained relatively stable over the course of these studies and even to the present time. We feel this may provide some explanation as to the low rates of aseptic loosening as we follow a strict cementation regimen. Our technique has consisted of perforation of any sclerotic bone with a drill bit in multiple drill holes to allow for adequate penetration. The bone is then thoroughly irrigated with pulse-lavage and thoroughly dried. Then, in its most viscous state, the cement is mixed and applied to the clean dry implant prior to any contamination. Following this, cement is applied to the prepared bone with the use of a cement gun or wide osteotome with several pressurizing passes made with the osteotome and thumb pressurization with significant focus of maximizing cement interdigitation to the prepared bone, with the goal of 3–5 mm of cement penetration. Meticulous cleaning of excess cement is performed. The tibia is cemented first, followed by the femoral component using the same technique under a single batch of cement. With the final bearing in place, the knee is then taken to extension and held still with slight constant pressure until the cement has fully cured in the bowl. Only then is the knee moved, inspected, and cleaned of any residual extruded cement.

While many factors may independently influence implant loosening, ultimately the underlying consideration to all of these factors is the cement application to the bone and implant. We feel that this is likely a factor that is less considered by surgeons and manufacturers, maybe under-assessed in survivorship studies given the inherent lack of discrete data on technique available to registry in database studies, and likely requires further investigation.

This study provides an analysis of just one potential source of information that could be referenced by practicing surgeons in regards to best practices in cementation. We fully recognize that the techniques that surgeons may actually employ during surgery are likely rarely influenced by product literature and can be assumed to be more influenced by their background, training, practices of their mentors, and on their own knowledge and experience. However, if there is an absence of best practice consensus in the published product literature, it is quite likely that there are few other published sources of consensus on best practice cementation techniques in TKA. Our findings represent, perhaps more than a scientific revelation, a potential call to ourselves and our organizations to consider making the topic of cementation technique a priority to gather additional data and provide a consensus agreement on best practices. Given the unaccounted-for variables that could be introduced by surgical technique, we feel that case series, database, or registry reviews raising concerns over implant designs or cement types may fall short of understanding the entire picture surrounding aseptic loosening and failure in TKA in modern practice.

This report has several imitations. Many of the surgical technique guides either had very little information or no information at all on cementation technique. Even after contacting representatives at the respective manufacturers, it was difficult to find any additional information or guidelines on cementation technique. We feel that part of the obstacle in obtaining clear guidelines for cementation could possibly be due to manufacturers’ efforts to purposefully limit information on cementation technique in their brochures and surgical technique guides to avoid off-label use. By doing so, they are not responsible for getting approval from governmental oversite agencies on the technique or device (polymethylmethacrylate, bone cement is an FDA class II device) and ultimately leave the cementation technique up to the cement manufacturers or surgeon’s preference. Further, we did not survey orthopedic surgeons to determine adherence to recommended cementation techniques found in the respective surgical technique guides, nor on their current practices. Knowing how surgeons learned their cementation technique and what cementation regimen they actually incorporate into their practice for TKA procedures might lead to greater insight on this topic. Many surgeons’ practices may be primarily influenced by the teachings of their mentors and their own clinical experience, as opposed to product guides or published recommended practices for cementation. Further research may be done to better understand the influence of surgical technique on the outcomes of aseptic loosening and failure following TKA.

Conclusion

There is clearly no consensus for a preferred cementation technique both within and among manufacturers’ surgeon education materials regarding tibial baseplate cementation during TKA. Efforts may be needed to identify a best-practice cementation technique in an effort to reduce the number of TKA failures associated with aseptic loosening. We recommend urgent action be taken to develop a working group to establish a consensus on the best practices in TKA cementation. At a minimum, acceptable standards and guidelines must be identified. Further research is needed to determine if different cementation techniques may account for differences in outcomes. To date, national registry data and most case series on outcomes focus on the implants rather than techniques. Standardization of all TKA cementation technique instructions should be forthcoming to improve the efficacy of TKAs.

Footnotes

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iD

Christopher E Pelt

Appendix 1

Table 1A.

Websites and date accessed for surgical guides reported.

Company	Implant	Date accessed	Web address
Zimmer Biomet	N/A	June 27, 2018	https://www.zimmerbiomet.com/content/dam/zimmer-biomet/medical-professionals/common/cement/modern-cementing-technique-brochure.pdf
Zimmer Biomet	Persona the personalized knee	June 27, 2018	http://www.zimmer.com/content/dam/zimmer-web/documents/en-US/pdf/surgical-techniques/knee/persona-knee-surgical-technique.pdf
Zimmer Biomet	Gender solutions natural-knee	June 27, 2018	www.zimmer.pt/content/dam/zimmer-web/documents/en-GB/pdf/surgical-techniques/knee/06.01733.012_ST_Gender_Sol_NK_Flex.pdf
Zimmer Biomet	Gender Solutions NexGen high-flex knee	June 27, 2018	http://www.zimmer.com/content/dam/zimmer-web/documents/en-US/pdf/medical-professionals/knee/zimmer-gender-solutions-nexgen-high-flex-implants-brochure.pdf
Zimmer Biomet	Zimmer NexGen LPS-flex mobile and LPS mobile-bearing knees	June 27, 2018	https://www.zimmerbiomet.com/content/dam/zimmer-biomet/medical-professionals/000-surgical-techniques/knee/zimmer-nexgen-lps-flex-mobile-and-lps-mobile-bearing-knee-surgical-technique.pdf
Zimmer Biomet	NexGen complete knee solution LPS-flex fixed bearing knee	June 27, 2018	https://www.zimmerbiomet.com/content/dam/zimmer-biomet/medical-professionals/000-surgical-techniques/knee/nexgen-lps-flex-fixed-bearing-knee-surgical-technique.pdf
Zimmer Biomet	Zimmer gender solutions PFJ system	July 7, 2018	http://www.zimmer.com/content/dam/zimmer-web/documents/en-US/pdf/surgical-techniques/knee/zimmer-gender-solutions-patello-femoral-joint-pfj-system-surgical-technique.pdf
Zimmer Biomet	Signature personalized patient care	July 7, 2018	https://pdf-url-resources.s3.amazonaws.com/resources/64180831.pdf?AWSAccessKeyId=AKIAJL52UHIJOU2TO4SQ&Expires=1533124800&Signature=Edm4XLHwc7OXlV5CEP8c0FGNt84%3D
Zimmer Biomet	Vanguard complete knee system	July 9, 2018	http://www.biomet.se/resource/17724/FLK167%20Vanguard%20Premier%20ST.pdf https://www.zimmerbiomet.com/content/dam/zimmer-biomet/medical-professionals/000-surgical-techniques/knee/premier-total-knee-instrumentation-surgical-technique1.pdf
Zimmer Biomet	Vanguard ID total knee	July 9, 2018	https://www.zimmerbiomet.com/content/dam/zimmer-biomet/medical-professionals/000-surgical-techniques/knee/vanguard-id-total-knee-surgical-technique.pdf
DePuy Synthes	N/A	June 28, 2018	http://synthes.vo.llnwd.net/o16/LLNWMB8/US%20Mobile/Synthes%20North%20America/Product%20Support%20Materials/Reference%20Guides/DSUSJRC11140580%20Guidance%20for%20Cementing%20TKR%2004-2015.pdf
DePuy Synthes	Sigma primary knee system	June 28, 2018	http://synthes.vo.llnwd.net/o16/LLNWMB8/US%20Mobile/Synthes%20North%20America/Product%20Support%20Materials/Technique%20Guides/SIGMA%20Primary%20Knee%20System%20ST.pdf
DePuy Synthes	Attune knee system	June 28, 2018	http://synthes.vo.llnwd.net/o16/LLNWMB8/US%20Mobile/Synthes%20North%20America/Product%20Support%20Materials/Technique%20Guides/DSUSJRC03161437%20Rev%204.pdf
DePuy Synthes	LCS complete knee system	June 28, 2018	http://synthes.vo.llnwd.net/o16/LLNWMB8/US%20Mobile/Synthes%20North%20America/Product%20Support%20Materials/Technique%20Guides/DSUSJRC03150784%20LCS%20HP%20ST.pdf http://synthes.vo.llnwd.net/o16/LLNWMB8/US%20Mobile/Synthes%20North%20America/Product%20Support%20Materials/Technique%20Guides/0611-63-050_DPY_LCS_Complete_Surgtech_Milestone_Instr_MBT_Tray_Prep.pdf
DePuy Synthes	AOX antioxidant polyethylene	June 28, 2018	Could not find surgical technique manual
Stryker	Triathlon total knee system	June 28, 2018	http://www.rpa.spot.pt/getdoc/6c03354b-afd9-4aa7-a2c9-40ba264a7af5/triathlon-knee-system-surgical-protocol-(stryker).aspx https://www.strykermeded.com/media/1165/triathlon-surgical-protocol.pdf
Stryker	Scorpio NRG	June 28, 2018	https://www.strykermeded.com/media/1501/scorpio-nrg-pr-technique-lsnrgpr_st.pdf https://www.strykermeded.com/media/1502/scorpio-nrg-ar-technique-lsnrgar_st.pdf
Stryker	Scorpio single axis	June 28, 2018	http://www.stryker.com/stellent/groups/public/documents/web_prod/022234.pdf
Stryker	Triathlon PKR	July 6, 2018	http://www.bizwan.com/_mydoc/stryker/Knee/031%20Triathlon%20PKR%20Surgical%20Technique.pdf
Stryker	AVON patello-femoral	July 6, 2018	http://www.avonpatella.com/ap_pdf_surgtech.pdf
Smith & Nephew	Legion CR, AS, and PS	June 29, 2018	https://www.smith-nephew.com/global/surgicaltechniques/recon/legion_dcf_02860v1_us.pdf
Smith & Nephew	GENESIS◊ II total knee	June 29, 2018	http://www.smith-nephew.com/global/assets/pdf/products/surgical/genii_primary_st.pdf http://www.bizwan.com/_mydoc/smithnephew/knee/Legion%20Genesis%20II%20Primary%20Knee%20Technique.pdf http://www.smith-nephew.com/global/surgicaltechniques/recon/genesisii_acf_40420114_us.pdf
Smith & Nephew	LEGION RK revision knee	July 6, 2018	http://www.smith-nephew.com/global/surgicaltechniques/recon/legion_revision_40830101_us.pdf
Smith & Nephew	LEGION HK hinge knee system	June 29, 2018	http://www.smith-nephew.com/global/assets/pdf/products/surgical/legion_hinge_st_02906.pdf
Aesculap	Vega system	June 29, 2018	https://www.aesculapimplantsystems.com/assets/base/doc/instructions/ais/orthopaedics/Vega_Knee_System_SOP-AIS-5000781.pdf
Aesculap	Columbus knee system	June 29, 2018	http://web.ros-medical.com/public/uploads/files/caderayrodilla/Columbus.pdf
Aesculap	Advanced surface technology	June 29, 2018	Could not find surgical technique manual
Aesculap	MIOS	June 29, 2018	http://itmedica.com/wp-content/uploads/2017/01/DOC620_Columbus_MIOS_ST.pdf
Aesculap	Univation X	June 29, 2018	Could not find surgical technique manual
Aesculap	Columbus AS revision knee system	June 29, 2018	Could not find surgical technique manual
Aesculap	EnduRo AS knee revision system	June 29, 2018	Could not find surgical technique manual
Ortho Development	Balanced knee system	July 2, 2018	https://www.odev.com/static/media/uploads/lit_knee_351-10694_10_2016_bks_surgical_technique.pdf
Ortho Development	BKS TriMax	July 2, 2018	https://www.odev.com/static/media/uploads/LIT_Knee_351-1-10748_rev_052016_BKS_TriMax_Surgical_Technique.pdf
Ortho Development	Balanced knee revision system	July 6, 2018	https://www.odev.com/static/media/uploads/LIT_Knee_351-1-10695_rev_022014_BKS_Revision_Surg_Tech.pdf
Medacta	GMK sphere	July 6, 2018	https://media.medacta.com/media/9926sphere12us-rev07.pdf
Medacta	GMK primary	July 6, 2018	https://media.medacta.com/media/992612icus-rev12.pdf
Conformis	iTotal PS	July 6, 2018	https://www.conformis.com/uploads/2017/09/MK-03032-AB-ITOTAL-PS-SURGICAL-TECHNIQUE-GUIDE-GAP-BALANCING-18.pdf https://www.conformis.com/uploads/2017/09/1.-iTotal-PS-Surgical-Technique-Guide-Measured-Resection.pdf
Conformis	iTotal CR	July 7, 2018	https://www.conformis.com/uploads/2017/09/iTotal-CR-Surgical-Technique-Guide-Gap-Balancing.pdf https://www.conformis.com/uploads/2017/09/MK-02900-AE-iTotal-CR-Surgical-Technique-Guide-Measured-Resection.pdf
Conformis	iUni	July 7, 2018	https://www.conformis.com/uploads/2017/09/iUni-Surgical-Technique-Guide-Tibia-First.pdf
Conformis	iDuo	July 7, 2018	https://www.conformis.com/uploads/2017/09/MK-02543-AE_iDuo-TF-STG1.pdf

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A potential need for surgeon consensus: Cementation techniques for total knee arthroplasty in orthopedic implant manufacturers’ guidelines lack consistency

Abstract

Aim:

Materials and Methods:

Results:

Conclusion:

Keywords

Introduction

Materials and methods

Results

Discussion

Conclusion

Footnotes

Declaration of conflicting interests

Funding

ORCID iD

Appendix 1

References