Orthopedics

Feature Article 

Agonizing and Expensive: A Review of Institutional Costs of Ankle Fusion Nonunions

Oliver J. Gagne, MDCM; Andrea N. Veljkovic, MD, FRCSC, MPH; Mark Glazebrook, MD, PhD, FRCSC; Murray Penner, MD, FRCSC; Kevin Wing, MD, FRCSC; Alastair S. E. Younger, MBChB, ChM, FRCSC

Abstract

Nonunion after ankle arthrodesis requiring revision is a challenging operative complication, and bone graft substitutes are costly. This study sought to summarize all institutional expenditures related to the revision of an ankle fusion nonunion, presuming that cost and skin-to-skin time would exceed those of the index surgery. The electronic records from 2 foot and ankle centers were reviewed, leading to a list of patients with 2 or more entries for tibiotalar fusions being generated. A total of 24 cases were found to match the criteria. Demographic factors and skin-to-skin time of the remaining patients were compiled. This cohort included 24 patients (6 female and 18 male) with a mean age of 64 years and body mass index of 30.4 kg/m2. Supplemental clinic visits and investigations were included either after computed tomography to assess union or 365 days after index surgery. Total cost of the revision was calculated from billing codes, length of operation, and period of hospitalization. Postrevision outpatient fees were included as well. The revisions were performed open in all cases, and 21 patients received autograft and/or bone substitute. Mean postoperative hospitalization was 3 days. The additional costs (in US dollars) associated with nonunion were $1061 for imaging, $627 for prerevision visits, $3026 for the revision, $3432 for the hospital stay, and $1754 for postrevision follow-up. The total mean amount was $9683, equivalent to 9 nights of acute inpatient stay. Mean index skin-to-skin time was 114 minutes, being 126 minutes for revisions (P=.26). Additional care related to ankle fusion nonunion represents a financial burden equivalent to 9 nights of acute inpatient stay. The use of an orthobiologic would need to be less than $436 to be cost saving. Revision surgery is not significantly longer intraoperatively than index surgery. [Orthopedics. 2020;43(x):xx–xx.]

Abstract

Nonunion after ankle arthrodesis requiring revision is a challenging operative complication, and bone graft substitutes are costly. This study sought to summarize all institutional expenditures related to the revision of an ankle fusion nonunion, presuming that cost and skin-to-skin time would exceed those of the index surgery. The electronic records from 2 foot and ankle centers were reviewed, leading to a list of patients with 2 or more entries for tibiotalar fusions being generated. A total of 24 cases were found to match the criteria. Demographic factors and skin-to-skin time of the remaining patients were compiled. This cohort included 24 patients (6 female and 18 male) with a mean age of 64 years and body mass index of 30.4 kg/m2. Supplemental clinic visits and investigations were included either after computed tomography to assess union or 365 days after index surgery. Total cost of the revision was calculated from billing codes, length of operation, and period of hospitalization. Postrevision outpatient fees were included as well. The revisions were performed open in all cases, and 21 patients received autograft and/or bone substitute. Mean postoperative hospitalization was 3 days. The additional costs (in US dollars) associated with nonunion were $1061 for imaging, $627 for prerevision visits, $3026 for the revision, $3432 for the hospital stay, and $1754 for postrevision follow-up. The total mean amount was $9683, equivalent to 9 nights of acute inpatient stay. Mean index skin-to-skin time was 114 minutes, being 126 minutes for revisions (P=.26). Additional care related to ankle fusion nonunion represents a financial burden equivalent to 9 nights of acute inpatient stay. The use of an orthobiologic would need to be less than $436 to be cost saving. Revision surgery is not significantly longer intraoperatively than index surgery. [Orthopedics. 2020;43(x):xx–xx.]

Ankle arthrodesis is the most commonly performed operative treatment for tibiotalar arthritis in high-demand patients due to its predictable reproducibility of outcomes compared with ankle replacement.1–3 Arthroscopic technique seems to improve patient outcomes4 while decreasing hospital-related costs remarkably.5

Surprisingly, the incidence of ankle fusion nonunions has been reported to range from 5.7%6,7 to 22.6%.8 Frey et al9 described a high rate of nonunion for posttraumatic arthritis with the initial diagnosis of talus fractures (67%), plafond fractures (59%), and combined talus/plafond fractures (75%). Smokers are 4 times more likely to experience a nonunion.10

Neuromuscular pathology has also been reported to interfere with union.11 Adjacent fusion of the subtalar joint (risk ratio, 3.89; P<.05) as well as preoperative varus alignment of greater than 10° have both been reported to increase rates of nonunion.12 Rheumatoid arthritis with the concurrent use of immunosuppressive medication has a similar nonunion rate.13,14 A nonunion in the lower extremity is an unfortunate challenge that involves a prolonged period of disability, burden to the patient, and significant use of health care resources.15

Although surgeons can choose the most suitable fixation method and the type of implant, few techniques involving biological adjuncts to increase the rate of successful unions have been established. Wheeler et al8 reported on locally generated bone slurry to increase the bridging at the 6- and 12-week marks. However, Crosby et al16 found that the ankle fusion rate could not be improved by bone grafting. Autograft from sites such as the ipsilateral iliac crest includes substantial morbidity17 of the operative site and prolongs inpatient stay.

On the other hand, the pharmaceutical industry offers suitable products to achieve union that differ in terms of their efficacy but commonly involve high cost. As outlined by Obremskey et al,18 individual surgeons are then left with the decision whether to use costly orthobiologics (bone morphogenetic protein, platelet-rich plasma) for improved outcomes while at the same time being under the constraints of limited health care resources in a single-payer system.

Preventing nonunion is an obvious priority for patients and surgeons, but at what cost? Although the cost of autogenous bone graft and its added morbidity has been previously examined,19 the current authors recognized that they had little information on the actual cost of an ankle fusion nonunion to their hospital system.

The authors set out to define a cohort of patients needing a revision ankle fusion for symptomatic nonunion to calculate the cost of all related institutional expenses. They also set out to determine at what point buying orthobiologics to decrease nonunions would become cost-effective. They hypothesized that the cost and skin-to-skin time of the revision would be greater than those of the index surgery and that orthobiologics would need to be less expensive than currently marketed to be cost-effective.

Materials and Methods

Study Design and Population

This study, which received institutional review board approval, was designed as a multicenter retrospective case-control chart review of all patients who had a symptomatic ankle fusion nonunion that required revision.

Patients were included in this study if their first tibiotalar arthritis procedure was performed at the authors' centers between 2004 and 2017 and was an ankle arthrodesis. The revision surgery for symptomatic tibiotalar nonunion also had to be performed at the authors' centers. Accordingly, patients who had their first procedure elsewhere and underwent revision at the authors' centers were excluded because the authors could not capture every expenditure until a referral was placed. The authors' outlined follow-up was defined by a group shared clinical practice pattern consisting of follow-up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and beyond if clinically required.

The relevant electronic medical record systems were searched for the period between 2004 and 2017 by 2 groups (4+1) of fellowship-trained foot and ankle surgeons (A.N.V., M.G., M.P., K.W., A.S.E.Y.) working in 2 referral centers with large catchment areas within 2 states. The electronic records of all patients who had a procedure code for tibiotalar fusion (694) were reviewed, leading to a list of patients who received a second surgery for nonunion being generated.

Data

Of the above described patients with 2 or more tibiotalar fusion codes on the same extremity, exclusions were applied to 1 who had a total ankle replacement as the initial index surgery, 2 who had had their index surgery elsewhere, 1 who received an elective ankle fusion revision for varus malunion, 1 who had a revision for progressing Charcot arthropathy, and 3 who had takedown ankle fusion to a replacement and subtalar fusion. Once these 8 patients were excluded, 24 remained.

Electronic medical records, hospital charts, and radiology software were reviewed for the 24 included patients. All data collection was performed by an independent surgeon (O.J.G.) observer who had privileges at both centers. Attention was focused on the patients' smoking status, type of arthritis, body mass index (BMI), age, diabetes status, and workers' compensation claim status.

Statistical Analysis

To determine the extra cost associated with a revision of a symptomatic non-union, every clinic visit, examination, revision surgery, and postrevision in-hospital stay were recorded for further analysis. The period following the index fusion was considered standard care and thus was not included in the calculation until a computed tomography (CT) scan was performed to investigate a potential nonunion. If a CT scan was absent, another milestone was established at the 1-year mark after the index procedure. Any intervention conducted after reaching 1 of the 2 milestones was considered outside of standard care and thus was included in the cost calculation. For every visit, the surgeon's billing fee was added to the hospital cost of any clinic visit as well as the cost of interventions (ie, radiograph, CT scan) performed. For the revision procedure, the surgeon's and the anesthesiologist's fees along with the hospital-derived bundled cost of the operating room, nursing staff, facilities, intraoperative fluoroscopy, implants, postanesthetic recovery unit, and inpatient hospital stay were added. Those calculations required the evaluation of the detailed records of the duration of the procedure as well as the inpatient stay. Postrevision clinic visits were added and calculated as mentioned above until the last follow-up related to the tibiotalar procedure was completed (Figure 1).

Graphic representation of the period of interest in chronological order.

Figure 1:

Graphic representation of the period of interest in chronological order.

Hospital billing codes, practitioners' billing fees, and references were used to calculate the total costs related to ankle fusion nonunion. These were acquired from the institution's finance department and from the centralized payment schedule.20 The total costs were reported in US dollars and also converted into equivalent inpatient overnight stays as a more tangible unit for advocacy.

The Student's t test and linear regression were used to evaluate the statistical significance of the collected data.

Results

The 24 patients identified with a non-union meant that the incidence of ankle fusions that required a revision for nonunion was 3.4%. Cases of nonunion that did not undergo further surgery were not captured.

As summarized in Table 1, the mean age at the time of surgery was 64 years (95% confidence interval [CI], 60–69), and 6 patients were female. The mean BMI was 30 kg/m2 (95% CI, 26–34). Nine (38%) patients had diabetes mellitus and 5 (21%) had inflammatory arthritis. Few of these patients (3 of 14) were involved in a workers' compensation claim. Only 2 patients (8%) were active smokers. Ten (42%) were former smokers who had ceased smoking more than 12 months ago. The majority (12; 50%) had never smoked. The index surgeries were performed arthroscopically in 13 cases (54%) and open in 11 cases (46%) through a lateral approach. Most patients had a screws-only construct. Two (8%) patients received a hindfoot nail.

Patient Characteristics

Table 1:

Patient Characteristics

Of the described cohort, 20 of 24 cases had a CT scan to assess nonunion and delayed union a mean of 290 days (95% CI, 192–387) after index surgery. The mean time between the CT-confirmed diagnosis of nonunion and revision surgery was 205 days (95% CI, 127–282). For the entire cohort, the mean time between index and revision surgery was 482 days (95% CI, 381–583). Open revision surgery was performed in all cases. In terms of intra-operative use of autograft, 10 cases had local autograft from the joint preparation, 5 cases had iliac crest bone graft, and 2 cases had proximal tibia graft (Table 2). As for bone substitutes, 3 cases received OSTEOSET T (Wright Medical Group, Arlington, Tennessee), 8 cases received AUGMENT (Wright Medical Group), 6 cases received Accell CONNEXUS (IsoTis Inc, Irvine, California), and 1 case received bone morphogenetic protein. Three cases did not use any adjuncts in the revision. Fourteen patients received a combination of 2 adjuncts listed above. The mean duration of a case was 126 minutes (95% CI, 112–179). The mean tourniquet time was 109 minutes (95% CI, 96–122).

Use of Bone Graft and Orthobiologics for Both Revision and Index Surgery

Table 2:

Use of Bone Graft and Orthobiologics for Both Revision and Index Surgery

After revision surgery, patients remained in the hospital a mean of 2 days (range, 1–13 days); 1 patient was discharged the same day. The mean number of clinic encounters after revision was 6 (range, 1–12), with the last follow-up occurring a mean of 475 days after the revision. One patient with multiple comorbidities and thromboembolic history died 3 days after discharge from the hospital. None of the patients had a repeat revision ankle fusion.

The first period, between diagnosis of nonunion and revision surgery, had a mean cost of $627 (95% CI, 366–888). The total cost of surgery was $3026 (95% CI, 2616–3437), consisting of $898 (95% CI, 761–1035) for the surgeon's billing fees, $256 (95% CI, 236–276) for anesthetic services, and $1883 (95% CI, 1531–2235) for the hospital-bundled operative cost. The subsequent inpatient stay cost a mean of $3432 (95% CI, 2219–4645). The mean cost of follow-up after revision was $1754 (95% CI, 1399–2110). The costs of radiological diagnostics from diagnosis of nonunion to last follow-up totaled $1061 (95% CI, 722–1400). If the case were to be performed in the ambulatory surgical center, the cost of inpatient stay would not apply.

A mean total cost of $9683 (95% CI, 8217–11,148) was incurred. For ambulatory surgical center cases, the total cost would be $6251 (95% CI, 3572–8929). The cost of a repeat fusion for nonunion differs significantly (P<.05) from the previously reported cost of a primary ankle fusion ($4104±$373).21 Because the cost of 1 overnight stay at the treating institution was $1129, it was concluded that the mean sum of the institutional costs of a nonunion revision would be equivalent to 9 inpatient overnight stays or 6 if the surgery was performed in an ambulatory surgical center.

Discussion

This study is the first of its kind to examine the clinical outcome of nonunion in ankle fusions and quantify its holistic institutional health system cost. This study offers crucial information to the surgeon advocating for tools to prevent this and opens the conversation with research and innovation industry teams. By encompassing 4 surgeons' practices, this study had a large number (N=24) of patients with a relatively rare condition.

The rate of revision for nonunion of 3.4% was lower than the 8.6% cited in a recent review by Abicht and Roukis.6 However, the current case-control study was not designed to report the incidence of nonunion but rather the rate of revision for nonunion. The authors' number was also only based on cases that underwent revision and did not capture patients with nonunion who chose to delay revision and continue with observation for health-related or social reasons. However, the revision rate is useful because the authors' centers are the only institutions in a large geographic region that take on revisions for ankle fusion nonunions. Furthermore, patients are unlikely to travel to another part of the country for their revision due to restrictions of their health care plan and the relatively limited access to a specialist's clinic. The authors' rate does not represent ankle fusion nonunions that led to below-the-knee amputations.

The current cohort's demographics were compared with the larger arthrodesis subgroup analysis of the parent prospective database previously reported by Daniels et al.1 Age, sex, and side matched those of the current cohort and were not identified to be different. The current non-union cohort had 9 of 24 (38%) patients with diabetes, whereas the arthrodesis subgroup had 18 of 107 (17%). Therefore, the current patients undergoing ankle fusion revision were twice as likely to have diabetes compared with the index procedure cohort.

The current nonunion cohort had a mean BMI of 30.4±8.32 kg/m2, whereas the arthrodesis subgroup had a mean BMI of 28.7±5.6 kg/m2, which was not statistically significant (P<.1506). This association has been reported previously.9,22

One of the striking findings of the current study was the impact that postoperative inpatient stay had on total cost. As seen in Figure 2, close to 40% of the overall additional cost due to nonunion was attributed to inpatient hospital stay. The total cost of added institutional interventions ($9683) was more than twice the cost of the index primary ankle fusion ($4104±$373).21 If the surgeries were performed at an ambulatory surgical center, the total cost would be $6251.

Stratified institutional cost of tibiotalar fusion nonunion.

Figure 2:

Stratified institutional cost of tibiotalar fusion nonunion.

Using allograft instead of autograft has been shown to facilitate earlier discharge, as allograft avoids the pain burden from the second operative site.23–25 The field of orthopedic surgery has seen an increase in orthobiologic products during the past 20 years, and different practices exist regarding their use in the index procedure. The current study highlighted that the higher the cost of a nonunion, the more valuable its prevention becomes. The correct use of an orthobiologic agent at index surgery, technical considerations of joint preparation, compression and fixation, and patient education and compliance all drive the incidence of nonunion.

Intangible costs that were not represented in this study can be substantial, even when standards of care are met.26 For reference, the public relations department handling various litigations and lawsuits with the use of legal counsel, the attribution of large compensation payout, and third-party risk management consultants represented £36 million for foot and ankle alone in the United Kingdom during a 17-year period.27 Although no causality could be concluded, the current study indicated a trend with certain well-known risk factors (increased BMI and diabetes). Because these risk factors increase the probability of a nonunion,28 surgeons should consider delaying operations until both conditions have been optimized.

On designing an intervention that would address a nonunion, one has to recognize the different causes from local biology, fixation, and patient factors. Given that the number needed to treat for this study was 29 and that the cost of a non-union is now known, the authors can infer that no more than $335 should be spent on an adjunct during every index surgery prior to outweighing the cost of ankle fusion nonunion. In the setting of an intervention or orthobiologic that is only 50% efficacious, that cost would then have to be $167 or less. If the surgery does not require postoperative admission in the ambulatory surgical center setting, no more than $216 should be spent on an adjunct during every index surgery or $108 if the intervention is 50% efficacious.

Against the authors' initial estimation, the mean skin-to-skin time did not differ (P>.05) between index (114 minutes) and revision (126 minutes) surgery. This is most likely attributable to the fact that all revisions were performed as open procedures.

Conclusion

Ankle fusion nonunion creates a financial burden on the health care system. The total institutional cost represents, on average, the equivalent of a 9-day inpatient stay in an acute care hospital, with approximately 40% of the overall expenses being related to the inpatient stay. The total cost in an ambulatory surgical center represents the equivalent of a 6-day inpatient stay. Responsible use of public funds for adjuncts in primary ankle fusion seems prudent for patients with diabetes and obesity. Additional efforts should be directed toward shortening postoperative admissions and developing integrated models of pain management from the intraoperative delivery of care to the community services. Further research is needed regarding orthobiologic products and their efficacy in reducing the rate of symptomatic nonunion, their harm reduction potential, and their cost-effectiveness.

References

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Patient Characteristics

CharacteristicValue
Demographics
  Patients, No.24
  Age at surgery, mean, y64 (95% CI, 60–69)
  Sex, female:male, No.6:18
  Body mass index, mean, kg/m230.4 (95% CI, 26–34)
  Side, right:left, No.10:14
  Diabetes mellitus, No.9 (38%)
  Smoker, No.
    At any time12 (50%)
    Nonsmoker12 (50%)
  Inflammatory arthritis, No.5 (21%)
  Workers' compensation case, No/total no.3/14 (21%)
Index surgery
  Open, No.11
  Arthroscopic, No.13
  Skin-to-skin time, mean, hours:minutes01:54 (95% CI, 01:41–02:06)
  Construct, No.
    Fibular plate and screws8
    2 screws7
    3 screws5
    4 screws0
    5 screws2
    Hindfoot fusion nail2
  Same day discharge, No.4
  Length of stay, mean, d3.05 (95% CI, 2–4)

Use of Bone Graft and Orthobiologics for Both Revision and Index Surgery

TypeNo.

Index SurgeryRevision Surgery
Adjunct
  Autograft
    Iliac crest15
    Proximal tibia02
    Joint preparation slurry local graft1010
   Allograft
    Femoral head10
  Bone substitute
    OSTEOSET T bone grafta23
    AUGMENT bone grafta48
    Bone morphogenetic protein01
    Accell CONNEXUSb96
    Dynagraftb10
No adjunct53
Authors

The authors are from Saint-Paul's Hospital, University of British Columbia (OJG, ANV, MP, KW, ASEY), Vancouver, British Columbia, and Queen Elizabeth Health Science Center (MG), Halifax, Nova Scotia, Canada.

Drs Gagne and Penner have no relevant financial relationships to disclose. Dr Veljkovic is a paid speaker for Arthrex and has received grants from Amniox Medical Inc and Zimmer Inc. Dr Glazebrook is a paid consultant for Cartiva Inc, Wright Medical/BMTI, Smith & Nephew, Ferring Inc, and BioSET Inc and has received research support from Cartiva Inc, Wright Medical/BMTI, Smith & Nephew, Ferring Inc, and BioSET Inc. Dr Wing is a paid consultant for Acumed Inc, Wright Medical, and Cartiva Inc and has received grants from Acumed Inc, COA-Hip Hip Hooray, Ferring Inc, Integra Life Sciences Corporation, Smith & Nephew, Synthes, DePuy, Bioventus, Amniox Medical Inc, Zimmer Inc, and Cartiva Inc. Dr Younger is a paid consultant for Cartiva Inc, Acumed Inc, and Wright Medical and has received grants from Acumed Inc, COA-Hip Hip Hooray, Ferring Inc, Integra Life Sciences Corporation, Smith & Nephew, Synthes, DePuy, Bioventus, Amniox Medical Inc, and Zimmer Inc.

Correspondence should be addressed to: Oliver J. Gagne, MDCM, Saint-Paul's Hospital, University of British Columbia, 11299-2775 Laurel St, Vancouver, BC V5Z 1M9, Canada ( o.gagne.md@gmail.com).

Received: December 20, 2018
Accepted: April 03, 2019
Posted Online: April 09, 2020

10.3928/01477447-20200404-01

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