Complications and Early-Term Radiographic Analysis of a Novel Active Compression Tibiotalocalcaneal Arthrodesis Nail With a Proximal Flexible Coil

Abstract

Background:

Tibiotalocalcaneal (TTC) arthrodesis is used among other methods as a salvage procedure for complex foot/ankle deformity. Fixation is usually achieved through plate/screw constructs or intramedullary (IM) nailing. Although IM nailing uses smaller incisions, fusion rates are variable and complications rates ranging from 25% to 55.7% have been reported. The Phantom ActivCore (AC) nail could serve as a viable alternative to traditional IM nailing by allowing for increased compression capacity and a potentially lower risk of stress fracture. However, no studies have described the early outcomes of TTC arthrodesis using the AC nail. The primary objective of this study was to determine the rates of early-term complications and radiographic union of the AC nail.

Methods:

Inclusion criteria consisted of patients who had undergone a tibiocalcaneal or TTC arthrodesis using the Phantom Hindfoot TTC Nail System with at least 6 months of follow-up. Radiographic analysis evaluated for successful union and flexibility of the flex coil. Patients were monitored for postoperative complications and additional secondary procedures.

Results:

Twenty-one patients were included and had an average follow-up of 9.4 ±4.7 months (range, 4.3-19 months). No intraoperative complications were reported. Seven patients experienced at least 1 adverse event, which included device migration, asymptomatic nonunion, symptomatic nonunion, bone stress reaction, device prominence, and screw breakage. There were no events of perioperative fractures or device breakage. Two patients required secondary surgical interventions. The 5 remaining patients were managed conservatively. An average nail coil flexion angle of 2.6 ± 3.1 degrees and 0.8 ± 1.59 degrees was found on lateral and anteroposterior radiographs, respectively. The overall union rate at a mean follow-up of 9.4 months was 90.4% (95% CI 69.6%, 98.8%).

Conclusion:

TTC arthrodesis via the AC nail demonstrated similar union rates and outcomes at short-term follow-up compared with rates generally reported in the literature for other IM nail constructs. The AC nail was able to function as designed and allow for motion at the proximal bone-implant interface.

Level of Evidence:

Level IV, retrospective case series study.

Keywords

tibiotalocalcaneal arthrodesis intramedullary nailing IM nail ActivCore nail

Introduction

Tibiotalocalcaneal (TTC) arthrodesis is used among other solutions as a salvage procedure in the setting of complex foot and ankle pathology, offering pain relief and a stable weightbearing platform. The incidence of TTC arthrodesis for failed TAA is increasing alongside its use for more common indications of the procedure such as Charcot neuroarthropathy, end-stage arthritis of the ankle and subtalar joint, and complex deformity through the hindfoot.²⁰ Optimizing outcomes of this procedure, including addressing patient-specific factors as well as implant-related considerations, is of paramount importance.

Multiple methods for TTC arthrodesis exist.^{1,3,5,9,12,13,19,21
-27,30,31,33,34} Although plate and screw constructs confer additional rigidity compared with intramedullary (IM) nailing, IM nails require smaller incisions that can be beneficial given the often tenuous nature of the soft tissues in many patients requiring TTC arthrodesis.¹⁷ Despite reasonable union rates after IM nailing, fusion rates can vary from 76% to 100% across series.^2,8,11,15,18 High reported rates of various complications (25%-55.7%) following TTC arthrodesis have impacted foot and ankle surgeons and patients.^2,8,11,15,18

The Phantom ActivCore (AC) nail (Paragon 28; Englewood, CO) was designed to address the variable nonunion rates and high incidence of complications after IM nailing for TTC arthrodesis. In addition to compression capacity through the use of an inner core, the AC nail offers up to 8 mm of compression through the ankle and subtalar joints through the use of a dynamic interlock hole. Moreover, the AC nail uses a proximal flexible coil (flex coil) which allows for stress sharing within the tibia, given concern for stress fracture arising postoperatively following TTC arthrodesis.⁶

Despite these theoretical advantages to conventional nailing options, no studies have outlined the early outcomes of TTC arthrodesis using the AC nail. Thus, the goals of the present study were to determine the early-term complications and radiographic union of the AC nail. Of specific concern, an instance of flex coil breakage exists in the literature.⁷ Thus, secondary goals were to assess the postimplantation radiographic efficacy of the dynamic compression feature and the integrity of the flex coil. We hypothesized comparable radiographic union rates compared with previous IM nail systems and low overall complication rates.

Methods

Data Collection

This study was approved by the institutional review board (IRB) at our institution. Inclusion criteria included the following: (1) the subject has undergone a tibiocalcaneal (TC) or TTC arthrodesis performed by a designated investigator during which they received an intramedullary nail from the Phantom Hindfoot TTC Nail System as indicated and (2) the subject has adequate radiographic and medical records for a minimum of 6 months of postoperative (±8 weeks) follow-up. There were no particular exclusion criteria. After application of inclusion and exclusion criteria, a total of 21 surgical procedures were performed using the Phantom AC nail during the period July 2020–June 2022 at one of 2 academic institutions.

Demographic information including gender, smoking status, diabetes status, and other comorbidities known to affect healing were collected via chart review for all included patients. Each patient's arthrodesis indications and the underlying causes for these indications was documented. Operative information including nail length, diameter, and structural allograft type were included.

Implant and Operative Technique

Approach for TTC arthrodesis was determined by surgeon preference and soft tissue–related considerations. The combined anterior ankle and sinus tarsi approach to the talus, the extensile lateral approach, or the posterior approach are all compatible with use of the Phantom AC nail. The appropriate approach was carried out and the tibiotalar and subtalar joints were denuded of any residual cartilage to subchondral bone using a combination of curettes, rongeur, and osteotomes. Both joint surfaces were further prepared using a 2.5-mm drill and curved 0.25-inch osteotome to fenestrate the subchondral bone. At this time, adjunctive bone autograft or synthetic orthobiologics were applied to the arthrodesis site.

After appropriate joint preparation, the ankle and hindfoot were held in anatomic alignment and provisionally pinned with 2-mm Kirschner (K)-wires, ideally placed medially and laterally to avoid interreference with the intramedullary canal. Fluoroscopic imaging was used to confirm the proper entry site for the guidewire and entry drill, and the guidewire was placed through the calcaneus and talus into the center of the intramedullary canal in the sagittal and coronal planes. Correct guidewire placement was verified on calcaneal axial view via fluoroscopic imaging. Following guidewire placement, entry drilling and sequential reaming up to the desired nail diameter was carried out. The AC nail outrigger was assembled and attached to the nail. The nail was inserted with the outrigger construct under fluoroscopic guidance to confirm appropriate depth of insertion.

Once the correct depth of insertion was achieved, the distal portion of the AC nail was locked in place. The inferior posteroanterior screw was first drilled, measured, and placed followed by the superior posteroanterior screw. The tibia screws were then drilled, measured, and placed from medial to lateral in the dynamic compression slot position. The inner core component of the AC nail was held in place through use of a tension screw during nail implantation. The tension screw was then removed, causing an expansion of the flex coil that translates the inner core proximally to activate intraoperative compression. The outrigger was then removed from the nail and an end cap was placed. Irrigation and closure were carried out, and patients were placed in a well-padded splint. Patients typically remained nonweightbearing for 6 weeks to allow for arthrodesis site union, and activity level was gradually progressed at that time based on patient characteristics and baseline function. Postoperative imaging can be found in Figure 1.

Figure 1.

Postoperative anteroposterior (left) and lateral (right) view of patient with a Paragon 28 Phantom ActivCore nail at 6 months postop.

Radiographic Outcomes

Radiographic investigation was performed by authors not involved with the surgical procedure. Successful union was defined as clear radiographic trabeculation across the arthrodesis site or sites including at least 3 cortices, and nonunion was defined when there was radiographic clear space within the fusion mass, as previously defined by De Vries et al.⁴

These radiographs also enabled the assessment of the proximal flexion angle degree in both the coronal and sagittal planes through review of the anteroposterior and lateral views, respectively. The proximal flexion angle was used to indicate the flexibility of the coil and to determine whether this flexibility remained intact following implantation at each follow-up time point of the study. For measuring, the first line was made at the midpoint of the distal, rigid portion of the nail, parallel to both the anterior and posterior portions of the nail. The second line was made at the midpoint of the flex coil portion of the nail, parallel to both the anterior and posterior aspects of the flex coil. The angle between these 2 lines was then measured and recorded (Figure 2). Thus, we were able to assess the capacity for flexibility of the flex coil after implantation at the 3-month time point. Furthermore, the dynamic behavior of the inner core of the nail was quantified during each follow-up evaluation by measuring its movement. The measurement was taken from the distal end of the inner core portion of the nail to the distal end of the nail (Figure 3).

Figure 2.

Measurement of proximal flexion angle on anterior-posterior (left) and lateral (right) weightbearing radiographs. Measurements were carried out using the Cobb angle function on our institution’s imaging review platform. The first line was made at the midpoint of the distal, rigid portion of the nail, parallel to both the anterior and posterior portions of the nail. The second line was made at the midpoint of the flex coil portion of the nail, parallel to both the anterior and posterior aspects of the flex coil. The angle between these 2 lines was then measured and recorded.

Figure 3.

Measuring the dynamic behavior of inner core of nail relative to the distal end. This measurement was obtained by using the ruler funtion on our institution’s imaging review platform. The measurement was taken from the distal end of the inner core portion of the nail to the distal end of the nail.

Complications

Patients were evaluated during the primary surgery for any issues with the implantation of the AC nail including issues with instrumentation. At each subsequent follow-up visits, patients were monitored for the presence of adverse events including nonunion, device migration, device loosening, nail or screw breakage, and fractures. Additional secondary procedures related to the device were recorded.

Data Analysis

Statistical analysis was conducted using SAS (Cary, NC). Descriptive statistics were computed to provide an overview of the study sample's outcomes, with categorical variables summarized through frequencies and percentages.

Results

Patient Series

Twenty-one patients (6 females and 15 males) were included in the analysis (Table 1). Their average age at the time of the arthrodesis procedure was 62.1±10.1 years (range, 44-83 years). The series included patients who had a diagnosis of diabetes (n = 11; 52.4%), neuropathy (n = 11; 52.4%), and vascular disease (n = 2; 9.5%). There were 11 nonsmokers (53.4%), 8 former smokers (38.1%), and 1 current smoker (4.8%) in the study. The smoking status of 1 patient was unknown (4.8%). The patients had an average BMI of 32.6 ± 5.8.

Table 1.

Patient Demographics and comorbidities.

Characteristics	ActivCore Nail (n = 21)
Mean age, y (SD)	62.1 (10.1)
Gender: female/male, n	6/15
Body mass index	32.6 (5.8)
Smoking status, n (%)
Current smoker	1 (4.8)
Former smoker	8 (38.1)
Nonsmoker	11 (52.4)
Unknown	1 (4.8)
Diabetes, n (%)	11 (52.4)
Neuropathy, n (%)	11 (52.4)
Other comorbidities, n (%)	16 (76.1)
Vascular disease, n (%)	2 (9.5)
Osteoporosis, n (%)	0 (0.0)

The average follow-up duration was 9.4 ± 4.7 months (range, 4.3-19 months) (Table 2). TTC arthrodesis was performed in 20 cases (95.2%) whereas TC arthrodesis was performed in 1 case (4.8%). The index procedures included primary arthrodesis (n = 12; 57.1%), revision arthrodesis (n = 5; 23.8%), revision after TAA (n = 1; 4.8%), and other revision surgery (n = 3; 14.3). Arthrodesis indications included bone loss or instability, revision surgery, or arthritis of the hindfoot and ankle. The most common cause of arthritis of the hindfoot and ankle were severe foot or ankle deformity (n = 13; 61.9%), posttraumatic arthritis (n = 5; 23.8%), osteoarthritis (n = 3; 14.3%), and rheumatoid arthritis (n = 2; 9.5%). Causes of bone loss or instability included Charcot neuroarthropathy (n = 9; 42.9%), talar deficiency conditions (n = 5; 23.8%), and trauma (n = 2; 9.5%). Indications for revision surgery were persistent nonunion or pseudoarthrosis of the hindfoot (n = 7; 33.3%), failed TC arthrodesis (n = 3; 14.3%), infected arthrosis (n = 2; 9.5%), and failed TAA (n = 1; 4.8%). Notably, patients could have had several causes for their indication for arthrodesis.

Table 2.

Preoperative, Intraoperative Factors, and Postoperative Factors.

Factor	ActivCore Nail (n = 21)
Follow-up, mo	9.4 (4.7)
Index procedure, n (%)
Primary	12 (57.1)
Revision: arthrodesis	5 (23.8)
Revision: total ankle	1 (4.8)
Revision: other	3 (14.3)
Bone loss or instability causes, n (%)
Charcot foot	9 (42.9)
Talar deficiency conditions	5 (23.8)
Trauma	2 (9.5)
Arthritis of hindfoot and ankle causes, n (%)
Severe foot/ankle deformity	13 (61.9)
Severe end-stage arthritis	5 (23.8)
Primary OA	3 (14.3)
Posttraumatic arthritis	5 (23.8)
Rheumatoid arthritis	2 (9.5)
Revision surgery causes, n (%)
Nonunion or pseudoarthrosis of hindfoot and distal	7 (33.3)
Revision of failed ankle arthrodesis	3 (14.3)
Previously infected arthrosis	2 (9.5)
Revision of failed TAA	1 (4.8)
Nail length, n (%)
150 mm	0 (0.0)
175 mm	2 (9.5)
200 mm	3 (14.3)
250 mm	15 (71.4)
300 mm	1 (4.8)
Nail diameter, n (%)
10.0 mm	7 (33.3)
11.5 mm	11 (52.4)
13.0 mm	3 (14.3)

Abbreviations: OA, osteoarthritis; TAA, total ankle arthroplasty.

The nails that were implanted included 10.0 mm (n = 7; 33.3%), 11.5 mm (n = 11, 52.4%), and 13.0 mm (n = 3; 14.3%) diameters. Nail length options included 175 mm (n = 2; 9.5%), 200 mm (n = 3; 14.3%), 250 mm (n = 15; 71.4%), and 300 mm (n = 1; 4.8%). Structural grafts used were allograft (n = 16; 76.2%) and metal cage (n = 2; 9.5%). No structural grafts were used in 3 cases (14.3%). Device implantation was successful in all 21 cases, and there were no issues reported while using the Paragon 28 Phantom AC nail installation instrumentation. A concurrent procedure was performed in 15 cases (71.4%).

Radiographic Outcomes

With regard to radiographic outcomes, two patients were observed to have nonunion at either the ankle or subtalar joint arthrodesis site as indicated by the presence of radiolucency at these arthrodesis sites. Thus, overall union rate at a mean follow-up of 9.4 months (284.9 days) was 90.4% (95% CI 69.6%, 98.8%). Comparisons were made between postoperative imaging obtained during each subsequent follow-up and the corresponding initial postoperative image (Table 3). All measurements were obtained at all follow-up time points, with the exception of the nail coil flexion angle that was only measured at the 3-month follow-up time point. Our results revealed that at the 3-month follow-up, the average displacement of the nail’s inner core was 2.5 ± 1.4 mm (range 1-6 mm). The 6-month and final follow-up visits demonstrated an average displacement of 2.3 ± 1.6 mm (range 1-6 mm) and 2.3 ± 1.2 mm (range 1-5 mm), respectively, nearly unchanged from the 3-month visit. With regard to nail coil flexion angle, an average of 2.6 ± 3.1 degrees (range –9 to 1 degrees) was observed on lateral radiographs (measuring the sagittal plane flexion angle, absolute value), whereas on the anteroposterior radiographs (measuring the coronal plane flexion angle, absolute value), it was 0.8 ± 1.59 degrees (range –2 to 7 degrees).

Table 3.

Radiographic Outcomes.

Evaluation	3-mo Follow-Up (n = 20)	6-mo Follow-Up (n = 20)	Final Follow-Up (n = 11)
Nail coil flexion angle, degrees (lateral radiograph), mean (SD, range)	2.6 (3.1, 0-9)
Nail coil flexion angle, degrees (AP radiograph), mean (SD, range)	0.8 (1.6, 0-7)
Displacement of inner core of nail, mean (SD, range), mm	2.5 (1.35, 1-6)	2.3 (1.56, 1-6)	2.3 (1.2, 1-5)

Abbreviation: AP, anteroposterior.

Complications

There were no intraoperative complications associated with the use of the AC nail (Table 4). All interlocking screws were found to pass through the nail via intraoperative imaging confirmation in all cases. Neither the nail nor any interlocking screws broke during any of the procedures. During postoperative visits, there were 7 patients (33.3%) who experienced at least 1 adverse event related to the device. Adverse events included device migration (n = 3; 14.3%), asymptomatic nonunion (n = 1; 4.8%), symptomatic nonunion (n = 1; 4.8%), bone stress reaction (n = 1; 4.8%), device prominence (n = 1; 4.8%), and screw breakage (n = 1; 4.8%). The 3 patients who experienced device migration were all asymptomatic at their follow-up visits and one of the patients had also demonstrated asymptomatic nonunion. The patient who exhibited a bone stress reaction presented with localization near the proximal aspect of the nail, situated within the midshaft of the tibia. The patient experienced pain that was successfully alleviated through a conservative approach using a custom orthotic brace. Notably, there were no reported events of perioperative fractures or device breakage in any of the patients. Among the 7 patients who encountered adverse events, 5 received conservative management, whereas 2 necessitated secondary surgical interventions. Consequently, the overall rate of requiring secondary procedures related to the device stood at 9.5% (n = 2). Ultimately, both patients necessitated a below-the-knee amputation. One patient underwent a below-the-knee amputation because of persistent nonunion resulting in chronic osteomyelitis with Charcot neuroarthropathy, while the other underwent the procedure because of a necrotizing soft tissue infection. When union status was analyzed based on baseline patient or surgical factors such as type of index procedure, smoking status, or diabetes, there were no statistically significant differences (Supplemental Table 1). Complication rates were also analyzed through subgroup analysis (Supplemental Table 2). There were no statistically significant differences between groups in regard to adverse events where relatedness was definite/probably/or possible, or where action taken was surgical and relatedness was definite/probably/or possible.

Table 4.

Clinical Outcomes.

Clinical/Surgical Outcomes	ActivCore Nail (n = 21)
Successful implantation of ActivCore Nail, n (%)	21 (100.0)
Issues with instrumentation during surgery, n (%)	0 (0.0)
Adverse events, n (%)	7 (33.3)
Device migration	3 (14.3)
Device loosening	2 (9.5)
Symptomatic nonunion	1 (4.8)
Asymptomatic nonunion	1 (4.8)
Bone stress reaction at tip of nail	1 (4.8)
Device prominence	1 (4.8)
Screw breakage	1 (4.8)
Perioperative fractures	0 (0.0)
Device breakage (nail)	0 (0.0)
Secondary procedures required, n (%)	2 (9.5)
BKA	2 (9.5)
Related to nonunion	1 (4.8)
Related to soft tissue	1 (4.8)
Nail removal outside of BKA	0 (0.0)

Abbreviation: BKA, below-the-knee amputation.

Discussion

In the first study of the AC nail for TTC arthrodesis, we present comparable early outcomes to the literature despite a high presence of comorbid conditions in our patient sample. We report 1 case of symptomatic nonunion ultimately requiring below-the-knee amputation in a patient with chronic osteomyelitis of the ankle in the setting of Charcot arthropathy. Overall union rate at a mean follow-up of 9.4 months (284.9 days) was 90.4%. Although device migration was present in 3 patients on radiographic analysis, only 1 patient was symptomatic and required an additional procedure. No occurrence of nail breakage was observed, and 1 calcaneus screw was found to be broken on radiographic analysis, but the patient remained asymptomatic. None of the surgeons reported any issues with instrumentation during surgery. These early results compare similarly to other TTC nail devices.

Numerous nailing options have been designed for use in TTC arthrodesis. Lucas et al¹⁴ present the results using the Tylos nail (FH Orthopedics, Heimsbrunn, France), a straight IM nail with a unique posterior locking system. These authors demonstrate high satisfaction rates and substantial improvements in American Orthopaedic Foot & Ankle Society (AOFAS) scores, improving from 29.7 ± 15.1 to 65.8 ± 14.6 after the procedure. Fusion rates of 86% in both the ankle and subtalar joints were comparable to the rate reported in our series (90.4%). Budnar et al.² achieved similar union rates (89%) in a series of 42 patients undergoing TTC arthrodesis with the use of a curved nail.

Currently, there is ongoing debate regarding the utility of a dynamic compression function in TTC nails with respect to successful union rate and time to union. Some nails have employed postoperative compression capability in an effort to achieve reduced nonunion rates.¹⁰ Steele et al²⁸ demonstrate a nonstatistically significant improvement in fusion rate (78.0%) with use of sustained dynamic compression IM nail with an internal nitinol element (DynaNail, MedShape, Inc, Atlanta, GA) when compared to nondynamic IM nails (75.0%). The low fusion rates in this series were attributed to patient factors including high rates of smoking and prior trauma and case specifics, such as revision surgery and frequent use of custom three-dimensionally (3D) printed custom cage implants. Despite the challenging patient cohort, the dynamized IM nail group had a significantly faster time to union by almost 4 months. Although we were unable to calculate time to radiographic union in our cohort, the successful dynamization component of the AC nail as demonstrated on postoperative radiographs warrants further investigation with larger sample sizes and longer-term follow-up. Direct comparison of various dynamization approaches may help guide implant design and improve nonunion rates in TTC arthrodesis.

High complication rates continue to impact patients undergoing TTC arthrodesis. In a recent meta-analysis of IM nailing for TTC arthrodesis, a similar union rate of 86.7% was observed in the pooled cohort of 631 patients.¹¹ Alarmingly, a complication rate of 55.7% was described, with a reoperation rate of 22%. The most common complication grouping occurring in 107 cases was denoted as “metalwork related,” including the following complication subtypes: “prominent metalwork, broken metalwork, ulcers due to metalwork, and stress reactions and stress fractures due to metalwork.”¹¹ Improvement of union rates for TTC arthrodesis remains a primary concern and is the focus of much investigation. In addition, the high rate of device-related complications highlighted in the systematic review emphasizes the importance of implant design in minimizing device prominence, broken screws and nails, and peri-implant stress fracture or stress reaction.

Stress reaction and stress fracture occurring after TTC arthrodesis have been commonly reported, and are thought to be due either to stress shielding and peri-implant osteolysis or to the creation of a stress riser at the proximal aspect of the device.^8,16,29,32 A chief design feature of the AC nail is the inclusion of a proximal flex coil designed to allow for more physiologic loading of the distal tibial bone surrounding the implant (Figure 2). As a further measure to reduce stress shielding in TTC arthrodesis, the AC nail is constructed of anodized titanium alloy, with a modulus of elasticity more closely replicating that of bone when compared to other metal alloys. No instances of nail breakage occurred, and one instance of peri-implant stress reaction that resolved with conservative care was encountered in the present study. The early results of the proximal flex coil feature of the AC nail are promising, and future work should aim to assess the AC nail at mid- to long-term intervals to determine whether the proximal flex coil effectively reduces stress shielding–related complications in TTC arthrodesis.

This study is limited by small patient sample size and the short-term nature of the follow-up. However, our sample mirrored other TTC arthrodesis series with regard to cohort demographics and presence of comorbid conditions, with a high prevalence of diabetes and procedures performed for complex deformity and in the revision setting. Additional studies should seek to identify functional benefits of the AC nail given the theoretical load-sharing capacity of the device.

Conclusion

TTC arthrodesis using the AC nail achieved similar union rates at short-term follow-up as compared to other IM nail constructs for TTC fusion. No implant breakage occurred and one peri-implant stress reaction that resolved with conservative care was noted. The function of a proximal flex coil designed to allow for motion at the proximal bone-implant interface was confirmed on postoperative radiographic analysis suggesting the compression component of the nail was found to function as designed.

Supplemental Material

sj-pdf-1-fao-10.1177_24730114251323895 – Supplemental material for Complications and Early-Term Radiographic Analysis of a Novel Active Compression Tibiotalocalcaneal Arthrodesis Nail With a Proximal Flexible Coil

Supplemental material, sj-pdf-1-fao-10.1177_24730114251323895 for Complications and Early-Term Radiographic Analysis of a Novel Active Compression Tibiotalocalcaneal Arthrodesis Nail With a Proximal Flexible Coil by Albert T. Anastasio, Kevin A. Wu, Emily J. Luo, Cesar De Cesar Netto and Mark E. Easley in Foot & Ankle Orthopaedics

Footnotes

Appendix

Supplemental Table 2.

Complication Rates by Baseline/Surgery Factors.

		Complication Rate 1		Complication Rate 2
	Overall n (%)	n (rate) [95% CI]	P Value	n (rate) [95% CI]	P Value
Type of Index Procedure			.64		.49
Primary	12 (57.1)	5 (0.42) [0.05, 0.78]		2 (0.17) [0.00, 0.40]
Revision – Arthrodesis	5 (23.8)	1 (0.20) [0.00, 0.59]		0 (0.00) [N/A, N/A]
Revision – Total Ankle	1 (4.8)	0 (0.00) [N/A, N/A]		0 (0.00) [N/A, N/A]
Revision – Other	3 (14.3)	1 (0.33) [0.00, 0.99]		0 (0.00) [N/A, N/A]
Smoking Status			.16		.19
Current	1 (4.8)	1 (1.00) [0.00, 2.96]		1 (1.00) [0.00, 2.96]
Former	8 (38.1)	4 (0.50) [0.01, 0.99]		1 (0.13) [0.00, 0.37]
Non-Smoker	11 (52.4)	2 (0.18) [0.00, 0.43]		0 (0.00) [N/A, N/A]
Unknown	1 (4.8)	0 (0.00) [N/A, N/A]		0 (0.00) [N/A, N/A]
Diabetes			.36		.48
Yes	11 (52.4)	5 (0.45) [0.06, 0.85]		2 (0.18) [0.00, 0.43]
No	10 (47.6)	2 (0.18) [0.00, 0.45]		0 (0.00) [N/A, N/A]

Abbreviations: n, number; CI, Confidence Interval; Rate1, Any adverse event where relatedness was definite/probably/possible; Rate2, Any adverse event where action taken was surgical and relatedness was definite, probable, or possible.

Ethical Approval

This study was approved by the Duke University Institutional Review Board (Pro00111456). All patient information is deidentified and there is no identifying information in this manuscript. Informed consent was obtained prior to participation in this prospective study.

Declaration of Conflicting Interests

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Albert Anastasio, MD, reports disclosures related to manuscript from QPix Solutions (other professional activities). Cesar De Cesar Netto, MD, PhD, reports disclosures related to manuscript from Paragon28 (consultant, medical advisory board, royalties), CurvebeamAI (consultant, shareholder), Ossio (consultant), Zimmer (consultant), Stryker (consultant), Exactech (consultant), Arthrex (consultant), and Extremity Medical (consultant). Mark Easley, MD, reports disclosures related to manuscript from Paragon28 (paid consultant, paid presenter or speaker), Exactech Inc (IP royalties, paid consultant, paid presenter or speaker, research support), Saunders/Mosby-Elsevier (publishing royalties, financial or material support), Springer (publishing royalties, financial or material support), Treace Medical (IP royalties, paid consultant, paid presenter or speaker), and Wolters Kluwer Health (Lippincott Williams & Wilkins: publishing royalties, financial or material support). Disclosure forms for all authors are available online.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was funded by Paragon 28 (Englewood, CO).

ORCID iDs

Albert T. Anastasio, MD,

Kevin A. Wu, BS,

Emily J. Luo, BS,

Cesar De Cesar Netto, MD, PhD,

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