Prevention of infection after joint replacement - is Betadine lavage effective

We note that some shoulder arthroplasty surgeons use Betadine (Povidone Iodine, PI) lavage in an attempt to reduce the risk of infection. Two recent studies of patients having hip and knee arthroplasties fail to support this practice.

Use of Povidone-Iodine Irrigation Prior to Wound Closure in Primary Total Hip and Knee Arthroplasty An Analysis of 11,738 Cases

These authors identified 5,534 primary THA and 6,204 primary TKA procedures. Cases were grouped on the basis of whether or not the wound was irrigated with 1 L of 0.25% Betadine prior to closure. Betadine irrigation was used in 1,322 (24%) of the THA cases and in 2,410 (39%) of the TKA cases.

The rate of reoperation for infection as assessed at 3 months following THA was similar between those who received dilute PI irrigation (0.9%) and who did not (0.7%) (p = 0.7). At 1 year, the rate of reoperation for infection was similar between those who received dilute PI irrigation (0.7%) and those who did not (0.9%) (p = 0.6). After using the propensity score, there was no difference between the groups in the risk of septic reoperations. For TKA, the rate of reoperation as assessed at 3 months was similar between those who received dilute PI irrigation (0.8%) and those who did not (0.3%) (p = 0.06). At 1 year, there was a greater rate of reoperations for infection among those who received dilute PI irrigation (1.2%) compared with those who did not (0.6%) (p = 0.03). However, there was no difference in the risk of septic reoperations between the groups after using the propensity score.


Povidone-Iodine Wound Lavage to Prevent Infection After Revision Total Hip and Knee Arthroplasty An Analysis of 2,884 Cases

These authors assessed the effectiveness of Betadine irrigation in reducing infection following revision total hips (THA) and and total knees (TKA).  Betadine lavage was employed in 27% of the revision THA cases and 34% of the revision TKA cases

After adjusting for baseline differences between the groups using the propensity-score weighted models, they found no significant difference in the rate of reoperation for infection at 3 months (p = 0.58 for revision THA, and p = 0.06 for revision TKA) and at 12 months (p = 0.78 for revision THA, and p = 0.06 for revision TKA). Nonetheless, the hazard ratios from the propensity-score model trended higher for patients who received Betadine lavage: 1.6 and 1.3 for revision THA at 3 and 12 months, respectively, and 2.9 at both 3 and 12 months for revision TKA.

They noted a trend toward higher rates for reoperation for infection among patients who received PI irrigation.

Comment: These studies do not provide support for the use of Betadine lavage in the prevention of revision for infection in primary or revision total hip and knee arthroplasty. In the discussion they provide evidence of the potential cytotoxic effects of Betadine lavage.

The authors do not provide information on the bacteria associated with reoperation for infection in these cases. 

While it is recognized that different bacteria are commonly associated with periprosthetic infections of the shoulder, this articles may prompt reconsideration of the use of Betadine lavage.
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Propionibacterium - hip and knee surgeons be aware!

These authors reviewed patients infected with P. acnes after total hip (12 cases), knee (18 cases)  and shoulder (35 cases) arthroplasty. Patients were included if they met the Musculoskeletal Infection Society criteria and were excluded if they had a polymicrobial culture. 74% of these patients were men.

Median ESR was significantly higher in the knee (38.0mm/h, IQR 18.0–58.0) and hip (33.5 mm/h, IQR 15.3–60.0) groups compared to the shoulder group (11.0 mm/h, IQR 4.5–30.5). 

C-reactive protein levels were higher in the knee (2.0 mg/dl, IQR 1.3–8.9) and hip(2.4 mg/dl, IQR 0.8–4.9) groups compared to the shoulder group (0.7 mg/dl, IQR 0.6–1.5). 

Median synovial fluid WBC was significantly higher in the knee group than shoulder group (19,950 cells/mm3, IQR 482–60,063 vs 750 cells/mm3, IQR 0–2825, respectively). 

Peripheral blood WBC levels were similar between groups, as was mean time of P. acnes growth in culture. 

Clindamycin resistance was present in all groups. 

The authors concluded that "the manner in which a patient with P. acnes PJI presents is joint specific. Inflammatory markers were significantly higher in the knee and hip groups compared to the hip and shoulder groups, and long hold anaerobic cultures up to 14 days are necessary to accurately identify this organism."

Comment: This study indicates that knee and hip surgeons must join shoulder surgeons in being aware of the presence of Propionibacterium in the wounds of patients coming for revision arthroplasty. This study does not provide data on the rate of Propionibacterium identification in their revision surgery. It also does not indicate whether it is the routine of their surgeons to routinely send specimens for Propionibacterium-specific cultures. Unless cultures are sent and properly cultured, the presence of this organism will be missed. 

This point is driven home by an article from 1999:

Detection of prosthetic hip infection at revision arthroplasty by immunofluorescence microscopy and PCR amplification of the bacterial 16S rRNA gene.

These authors compared the detection rates of bacterial infection of hip prostheses by culture and nonculture methods were compared for 120 patients with total hip revision surgery. 

By use of strict anaerobic bacteriological practice during the processing of samples and without enrichment, the incidence of infection by culture of material dislodged from retrieved prostheses after ultrasonication (sonicate) was 22%.

Bacteria were observed by immunofluorescence microscopy in 63% of sonicate samples with a monoclonal antibody specific for Propionibacterium acnes and polyclonal antiserum specific for Staphylococcus spp. The bacteria were present either as single cells or in aggregates of up to 300 bacterial cells. These aggregates were not observed without sonication to dislodge the biofilm. Bacteria were observed in all of the culture-positive samples, and in some cases in which only one type of bacterium was identified by culture, both coccoid and coryneform bacteria were observed by immunofluorescence microscopy. Bacteria from skin-flake contamination were readily distinguishable from infecting bacteria by immunofluorescence microscopy. Examination of skin scrapings did not reveal large aggregates of bacteria but did reveal skin cells. These were not observed in the sonicates.

Bacterial DNA was detected in 72% of sonicate samples by PCR amplification of a region of the bacterial 16S rRNA gene with universal primers. All of the culture-positive samples were also positive for bacterial DNA. Evidence of high-level infiltration either of neutrophils or of lymphocytes or macrophages into associated tissue was observed in 73% of patients.

Note the prevalence Propionibacterium.

In conclusion, this study implicates unrecognized infection as a potential major cause of prosthetic hip failure. IFM allows a rapid quantitative and qualitative assessment of infected prostheses and distinguishes the bacteria from the infected prostheses from bacteria that may result from skin contamination. The IFM results indicate that 63% of retrieved hip prostheses may be colonized with bacteria. 16S rRNA genes were detected from 72% of retrieved prostheses. We are investigating the nature of the bacteria detectable by PCR amplification but not by IFM.

Their results indicate that the incidence of prosthetic joint infection is grossly underestimated by current culture detection methods.

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Periprosthetic infections: Stealth (Propionibacterium) vs Obvious (MSSA) in the total knees

Clinical Analysis of Propionibacterium acnes Infection after Total Knee Arthroplasty

These authors compared patients undergoing revision TKA for infection from P. acnes and methicillin sensitive Staphylococcal aureus (MSSA) Patients were classified as having a periprosthetic joint infection (PJI) based on the Musculoskeletal Infection Society criteria.

Sixteen patients with a P. acnes and 30 with a MSSA TKA PJI were identified. 

Median ESR was significantly higher in the MSSA group compared to the P. acnes group (56.0 mm/hr vs. 23.0 mm/hr, as were C-reactive protein levels (5.9 mg/dl vs 2.0 mg/dl).

Mean time to culture was 8.3±2.0 days in the P. acnes group and 1.8±0.8 days in the MSSA group.

Comment: As this case series and others point out, Propionibacterium infections are not unique to the shoulder. While the Musculoskeletal Infection Society criteria were used to select cases for this report, we know that many failed arthroplasties that are culture positive for Propionibacterium will not meet these criteria.

It may be important to culture tissue and explants from apparently 'aseptic' failure of total hip and knee arthroplasty for Propionibacterium using aerobic an anaerobic media observed for 3 weeks. It is for sure that the clinical presentation of a PJI with Propionibacterium is most likely to be of the 'stealth' variety, in contrast to the 'obvious' type of infections that meet the Musculoskeletal Infection Society criteria.

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Systematic Review of Patient-specific Instrumentation: New but Not Improved

Systematic Review of Patient-specific Instrumentation in Total Knee Arthroplasty: New but Not Improved

These authors asked: (1) Do patient-specific cutting blocks achieve neutral mechanical alignment more reliably during TKA when compared with conventional methods? (2) Does patient-specific instrumentation (PSI) provide financial benefit through improved surgical efficiency? (3) Does the use of patient-specific cutting blocks translate to improved clinical results after TKA when compared with conventional instrumentation?

They performed a systematic review in accordance with Cochrane guidelines of controlled studies (prospective and retrospective) in MEDLINE® and EMBASE® with respect to patient-specific cutting blocks and their effect on alignment, cost, operative time, clinical outcome scores, complications, and survivorship. Sixteen studies (Level I–III on the levels of evidence rubric) were identified and used in addressing the first question, 13 (Level I–III) for the second question, and two (Level III) for the third question. Qualitative assessment of the selected Level I studies was performed using the modified Jadad score; Level II and III studies were rated based on the Newcastle-Ottawa scoring system.

The majority of studies did not show an improvement in overall limb alignment when PSI was compared with standard instrumentation. 

Mixed results were seen across studies with regard to the prevalence of alignment outliers when PSI was compared with conventional cutting blocks with some studies demonstrating no difference, some showing an improvement with PSI, and a single study showing worse results with PSI. 

Mixed results were seen regarding the influence of PSI on operative times. Decreased operative times were not uniformly observed, and when noted, they were found to be of minimal clinical or financial significance. 

The accuracy of the preoperative plan, generated by the PSI manufacturers, was found lacking, often leading to multiple intraoperative changes, thereby disrupting the flow of the operation and negatively impacting efficiency. 

Limited data exist with regard to the effect of PSI on postoperative function, improvement in pain, and patient satisfaction. Neither of the two studies we identified provided strong evidence to support an advantage favoring the use of PSI. 

No identified studies addressed survivorship of components placed with PSI compared with those placed with standard instrumentation.

The authors concluded that PSI for TKA has not reliably demonstrated improvement of postoperative limb or component alignment when compared with standard instrumentation. Although decisive evidence exists to support that PSI requires fewer surgical trays, PSI has not clearly been shown to improve overall surgical efficiency or the cost-effectiveness of TKA. Mid- and long-term data regarding PSI’s effect on functional outcomes and component survivorship do not exist and short-term data are scarce. Limited available literature does not clearly support any improvement of postoperative pain, activity, function, or ROM when PSI is compared with traditional instrumentation.

Comment: While this article concerns patient-specific instrumentation for total knee arthroplasty - the most commonly performed of joint replacements - it does not provide encouragement for the use of PSI in the shoulder.

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Patient specific surgical guides - are they of value in improving clinical outcomes?

Small improvements in mechanical axis alignment achieved with MRI versus CT-based patient-specific instruments in TKA: a randomized clinical trial.

There is enthusiasm in some quarters for the application of 'patient-specific' instruments for shoulder arthroplasty (see here and here), however the value of this technology in improving patient outcomes has yet to be demonstrated. Because total knee arthroplasty (TKA) is performed more commonly than total shoulder arthroplasty and because the effects of non-anatomic alignment have been well documented for TSA, it seems of interest to include a study of the effect of MRI- and CT-based patient-specific instrumentation on validated outcomes scores for knee arthroplasty.

These authors conducted a randomized clinical trial in which 90 patients were enrolled and divided into three groups: CT-based, MRI-based patient-specific instrumentation, and conventional instrumentation. The groups were not different regarding age, male/female sex distribution, and BMI. 

Compared with conventional instrumentation MRI- and CT-based patient-specific instrumentation showed higher accuracy regarding

(1) the coronal limb axis (MRI versus conventional, 1.0°; CT versus conventional, 3.0°,

(2) femoral rotation (MRI versus conventional; CT versus conventional, 1.0°)

(3) tibial slope (MRI versus conventional, 1.0°, CT versus conventional, 1.0°), 

While these differences were statistically significant, they were small.

There were no differences in the postoperative Knee Society pain and function and WOMAC scores among the groups.

The authors concluded that patient-specific instrumentation increased accuracy in comparison to conventional instrumentation, the differences were only subtle and of questionable clinical relevance. In the absence of differences in the long-term clinical outcome or survivorship, the authors do not recommend widespread use of this technique.

Comment: The results and conclusions of this study are similar to those of another study covered in a previous post. The authors do not present the cost and time necessary for the patient-specific instrument approach. It would be of interest to know how much extra resource was consumed in the effort to improve alignment by a few degrees. 

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Experience lessens failure rate in joint replacement

Influence of Hospital Volume on Revision Rate After Total Knee Arthroplasty with Cement

This study concerned 37,381total knee arthroplasties that were reported to the Norwegian Arthroplasty Register from 1994 to 2010.

The rate of prosthetic failure at ten years was 7.5% for hospitals with an annual volume of one to twenty-four procedures and 4.5% for hospitals with an annual volume of ≥150 procedures. There was a significantly lower risk of revision for hospitals with an annual volume over 100 procedures compared with hospitals with an annual volume of one to twenty-four procedures.

The authors point out that prior reports have associated lower hospital and surgeon volume with higher short-term risk of complications, adverse outcomes and mortality.

It is not clear whether the failure rates continue to drop with even higher annual procedure volumes.

As the authors point out, the "benefits of high volume probably include not only improved surgical technique but also a better understanding of the importance of patient selection and the indications for surgery."

While these results concern total knee arthroplasty, we note that shoulder arthroplasty is no simpler than total knee arthroplasty; thus it is likely that the same phenomena and perhaps the same volume thresholds exist for shoulder joint replacement.

Similar results were recently reported in Impact of Hospital Volume on Postoperative Complications and In-Hospital Mortality After Musculoskeletal Tumor Surgery: Analysis of a National Administrative Database.

It appears that experience is the great teacher.

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Variability in Costs Associated with Total Hip and Knee Replacement Implants. JBJS

Variability in Costs Associated with Total Hip and Knee Replacement Implants. JBJS

The authors point out that the average implant cost per case varied by over 600% ($1797 to $12093) for total knee replacement procedures and by over 400% ($2392 to $12651) for total hip replacement procedures.  These wide variances could not be explained by differences in patient characteristics. The ratio of device cost to total surgical cost for knee and hip arthroplasty can be as high as 87%, with the median ratio being 43%.

The authors point out that data are currently lacking to support the belief that higher cost devices are associated with better outcomes. This is an important article, especially when viewed in the light of the survivorship of some of the more expensive and 'more modern' implants as also shown here. On this basis some have advocated device regulation to assure that new technology is optimally applied.

While we are not aware of similar data for shoulder implants, it is logical to assume that the same phenomenon exists there. We have also seen that the results with newer shoulder implants may not justify the associated expense. Determination of differences in outcome may require quite long term followup.

An interesting commentary on this article was offered: Joint Replacement Costs in the Era of Healthcare Reform: Commentary on an article by James C. Robinson, PhD, MPH, et al.: “Variability in Costs Associated with Total Hip and Knee Replacement Implants” The author of this commentary reminded that orthopaedic implants and procedures are major contributors to the rising cost of healthcare. In spite of the rising number of these procedures performed each year, the cost of these procedures is not following 'economies of scale principles' in which the implant cost per case would drop as the number of cases increased. The author of the commentary suggests several possible approaches to reducing these costs: (1) collective bargaining by Medicare with the implant manufacturers, (2) defining standards on the impact of new devices on cost and outcomes before they come to market, opining that 'there is little evidence that newer and more expensive devices are associated with better functional outcomes', (3) lack of  'gain-sharing' between medical centers and surgeons, which could incentivize surgeons to cut costs without compromising outcomes, and (4) lack of a national joint registry, such as those that exist in other countries, that would provide cost and outcomes data that could inform future decisions on implant selection for particular categories of patients.

The bottom line is that in future we need to pay more attention to the value equation: how much better are the documented results with the new implant divided by how much more it costs than the existing device? If a country wanted to curb the rising cost of joint arthroplasty, would it be better for it to reduce the cost of implants or to reduce the payments to the surgeons implanting them? That choice may be on us sooner rather than later.

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