Abstract
Background
Treatment of foot and ankle critical-sized defects (CSDs) remains a surgical challenge. Custom 3D-printed metallic implants have emerged as a promising solution, however current literature is limited. This study evaluated the incidence and associated factors of deep postoperative infection following custom cage implantation.
Methods
A retrospective cohort study was conducted on 62 patients who underwent custom cage implant arthrodesis. Pre-, peri-, and postoperative variables were collected, with deep postoperative infection as the primary outcome.
Results
Of 62 patients, 13 (21 %) developed deep postoperative infections at a median 957 days. Superficial wound breakdown was significantly associated with infection. History of ipsilateral foot and ankle infection, diabetes, smoking, and neuropathy were not significantly associated with infection.
Conclusion
Infection rates after custom cage implantation were comparable to those of traditional CSD management methods. These findings support continued evaluation of custom cage implants and emphasize the importance of reducing postoperative infection risk.
Level of evidence
III
1
Introduction
Critical-sized defects (CSDs) of bone are increasingly encountered in foot and ankle surgery and present a significant orthopaedic challenge due to limited soft tissue, poor vascularity, and high infection risk ,,, . These defects are bone voids that exceed the body’s innate capacity to heal during a lifetime, which is approximately 2–2.5 times the bone’s diameter or greater than 50 % circumferential bone loss ,,, . They may result from a variety of etiologies, including trauma, tumor, avascular necrosis, infection, after acute deformity correction, and failed total ankle arthroplasty (TAA) ,, . Traditional treatment strategies include bone transport, autografts, allografts, vascularized bone transfer, or the Masquelet (i.e., induced membrane) technique ,,, . These techniques remain standard of care, but are associated with high complication rates, including nonunion, infection, reoperation, and failure . No single approach has consistently met all clinical needs to optimize the microenvironment while minimizing patient morbidity .
An emerging solution for treatment of CSDs involves use of a custom 3D-printed metallic implant (i.e., custom cage) designed to precisely match the patient’s anatomy . Custom-made implants have multiple advantages: improved structural integrity, single-stage operation, no need for intraoperative contouring or invasive autograft harvest, avoidance of allograft rejection, and decreased non-weight-bearing periods postoperatively ,,,,,, . Early clinical results suggest promising outcomes in bony fusion and functional recovery, however current data is limited by small cohorts and short-term follow-up ,,,, . There remains an unmet need for large sample sizes and long-term follow-up.
The most serious complication of CSDs treated with 3D-printed metal implants is deep postoperative infection, which can result in patient morbidity, mortality, and increased healthcare cost. Reported infection rates in prior smaller custom cage studies ranged between 6.7 % and 20 %, however characterization of these outcomes remain limited in literature , . Other techniques for CSD treatment of the foot and ankle have infection outcomes ranging from 1 % to 20 % ,,,, . Thus, the purpose of this study was to analyze postoperative infections in the largest single-surgeon cohort to-date on custom cage implant arthrodesis. We hypothesized that custom cage implants will display similar infection rates to traditional treatments and to prior custom cage cohorts.
2
Methods
2.1
Overall study design
This retrospective cohort study included a consecutive series of 68 patients who underwent limb salvage surgery between June 1, 2014 and April 1, 2025. All patients who had failed prior nonoperative or operative management received a custom 3D-printed implant tailored to their specific defect. Six patients were excluded due to insufficient follow-up, resulting in a final cohort of 62 patients. Patients provided informed consent after thorough counseling on surgical risks and alternative treatment options. Clinical indications for surgery included the following: traumatic defects and deformities, post-reconstruction defects, failed arthrodesis, failed TAA, avascular necrosis, and Charcot deformities. Contraindications included active infection, neurovascular compromise, poor soft tissue or bone quality, and foreign body sensitivity.
Following institutional review board approval, patient data was collected on preoperative risk factors, perioperative characteristics, and postoperative outcomes. Preoperative risk factors included age at surgery, body mass index (BMI), sex, race, ethnicity, and medical history (e.g., diabetes, smoking, neuropathy, prior foot and ankle infection, and prior foot and ankle surgeries). Perioperative data included surgical indication, implant brand and lattice type, cage design, defect size, laterality, and operative time. Postoperative outcomes included complications (e.g., implant removal, superficial wound breakdown (SWB), deep infection, and limb amputation), reoperations, and radiographic evaluation for osseointegration at 6 months, 1 year, and 2 years follow-up. Osseointegration was defined prior to analysis and was assessed by implant seating, absence of peri-implant lucency, and signs of bone remodeling , . Osseointegration was independently evaluated by two foot and ankle fellowship-trained orthopaedic surgeons.
2.2
Custom implant design
Custom implant design has previously been discussed in Hamid, et al . In brief, implants in this cohort were fusion implants. A CT scan of the affected limb was used to design a patient-specific implant in collaboration between the surgeon and the manufacturer’s engineering team. After surgeon approval, the implant was 3D-printed and post-processed. Devices used included 4WEB (truss) and restor3d (gyroid) implants, categorized into seven types: midfoot wedge, navicular replacement cage, hindfoot wedge, talus replacing sphere, tibial and talar replacement tower, intratibial cage, and tibial replacement tower. All procedures were performed by the senior author.
2.3
Statistical analysis
The primary outcome of this study was post-operative deep infection. Comparison was made between patients with and without postoperative infection to identify perioperative variables associated with infection.
Demographic and perioperative variables were compared between infection and non-infection cohorts using chi-square tests for categorical variables and Fisher’s exact or Wilcoxon rank-sum tests for continuous variables. Each variable was reported as a median value with an interquartile range (IQR). These variables were also compared across three infection-timing subgroups: early (≤3 months postoperatively), delayed (3–24 months) and late (>24 months) . A univariate linear regression assessed associations between deep infection and selected preoperative (e.g., BMI) and perioperative variables (e.g., lattice type, SWB), reporting odds ratios with 95 % confidence intervals (CI). A p-value < 0.05 was considered statistically significant. All analyses were conducted in R version 4.4.1 (R Project for Statistical Computing, Vienna, Austria). For the infection cohort, an in-depth table detailed each patient’s clinical course, including perioperative variables and culture results.
3
Results
3.1
Overall results of cohort
Full details of the overall patient cohort and infection cohort can be found in Table 1 . Within the study period, there were 62 patients who received a custom cage implant with a minimum of 6 months follow-up. A breakdown of patient inclusion can be seen in Fig. 1 . The median age of the cohort was 58.5 years old with 48 % of the cohort being female. The most common clinical indication for the custom cage implant was traumatic defects/deformities (19), followed by Charcot deformities (13), failed arthrodesis (13), failed TAA (12), post-reconstruction defects (3), and avascular necrosis (2). Median follow-up time was 726.5 days [IQR 461.8, 1872.0]. Evidence of radiographic osseointegration was seen in 75 % of patients (45/60) at 6 months, 85 % of patients (39/46) at 1 year, and 92 % of patients (36/39) at 2 years.
Table 1
Overall results of cohort.
| Variable | Overall (N = 62) | Infection Status | p-value | |
|---|---|---|---|---|
| Infection (N = 13) | No Infection (N = 49) | |||
| Age (years) | 58.5 (46.8, 68.0) | 55.0 (52.0, 62.0) | 61.0 (46.0, 69.0) | 0.586 |
| BMI (kg/m 2 ) | 32.7 (27.9, 35.3) | 34.7 (31.5, 42.0) | 31.5 (27.6, 35.2) | 0.079 |
| Follow-up Time | 726.5 (461.8, 1872.0) | 1935.0 (1084.0, 2601.0) | 579.0 (378.0, 1217.0) | 0.003* |
| Number of Prior Foot/Ankle Surgeries | 2.0 (1.0, 3.8) | 3.0 (1.0, 3.0) | 2.0 (1.0, 4.0) | 0.813 |
| Defect Size (cm 2 ) | 4.7 (4.0, 7.0) | 5.3 (3.9, 10.5) | 4.7 (4.0, 6.8) | 0.666 |
| Time to infection (days) | – | 957.0 (159.0, 1711.0) | – | – |
| Sex | ||||
| Female | 30/ 62 (48 %) | 5/ 13 (38 %) | 25/ 49 (51 %) | 0.421 |
| Male | 32/ 62 (52 %) | 8/ 13 (62 %) | 24/ 49 (49 %) | |
| Race | ||||
| American Indian or Native Alaskan | 1/ 62 (2 %) | 1/ 13 (8 %) | 0/ 49 (0 %) | 0.412 |
| Asian | 1/ 62 (2 %) | 0/ 13 (0 %) | 1/ 49 (2 %) | |
| Black/African American | 9/ 62 (15 %) | 1/ 13 (8 %) | 8/ 49 (16 %) | |
| Caucasian/White | 49/ 62 (79 %) | 11/ 13 (85 %) | 38/ 49 (78 %) | |
| Not Reported | 2/ 62 (3 %) | 0/ 13 (0 %) | 2/ 49 (4 %) | |
| Ethnicity | ||||
| Hispanic/Latino | 1/ 62 (2 %) | 0/ 13 (0 %) | 1/ 49 (2 %) | 1.000 |
| Not Hispanic/Latino | 57/ 62 (92 %) | 12/ 13 (92 %) | 45/ 49 (92 %) | |
| Not Reported | 4/ 62 (6 %) | 1/ 13 (8 %) | 3/ 49 (6 %) | |
| History of Diabetes | ||||
| No | 37/ 62 (60 %) | 6/ 13 (46 %) | 31/ 49 (63 %) | 0.264 |
| Yes | 25/ 62 (40 %) | 7/ 13 (54 %) | 18/ 49 (37 %) | |
| History of Smoking | ||||
| No | 34/ 62 (55 %) | 9/ 13 (69 %) | 25/ 49 (51 %) | 0.350 |
| Yes | 28/ 62 (45 %) | 4/ 13 (31 %) | 24/ 49 (49 %) | |
| History of Neuropathy | ||||
| No | 37/ 62 (60 %) | 7/ 13 (54 %) | 30/ 49 (61 %) | 0.630 |
| Yes | 25/ 62 (40 %) | 6/ 13 (46 %) | 19/ 49 (39 %) | |
| History of Prior Foot/Ankle Surgery | ||||
| No | 9/ 62 (15 %) | 3/ 13 (23 %) | 6/ 49 (12 %) | 0.381 |
| Yes | 53/ 62 (85 %) | 10/ 13 (77 %) | 43/ 49 (88 %) | |
| History of Infection | ||||
| No | 49/ 62 (79 %) | 11/ 13 (85 %) | 38/ 49 (78 %) | 0.717 |
| Yes | 13/ 62 (21 %) | 2/ 13 (15 %) | 11/ 49 (22 %) | |
| Reason for Index Operation | ||||
| Avascular Necrosis | 2/ 62 (3 %) | 0/ 13 (0 %) | 2/ 49 (4 %) | 0.075 |
| Charcot Deformities | 13/ 62 (21 %) | 6/ 13 (46 %) | 7/ 49 (14 %) | |
| Failed Arthrodesis | 13/ 62 (21 %) | 3/ 13 (23 %) | 10/ 49 (20 %) | |
| Failed TAR | 12/ 62 (19 %) | 0/ 13 (0 %) | 12/ 49 (24 %) | |
| Post Reconstruction Defects | 3/ 62 (5 %) | 1/ 13 (8 %) | 2/ 49 (4 %) | |
| Traumatic Defects/Deformities | 19/ 62 (31 %) | 3/ 13 (23 %) | 16/ 49 (33 %) | |
| Implant Type | ||||
| Hindfoot Wedge | 2/ 62 (3 %) | 0/ 13 (0 %) | 2/ 49 (4 %) | 0.011* |
| Intratibial Cage | 4/ 62 (6 %) | 0/ 13 (0 %) | 4/ 49 (8 %) | |
| Midfoot Wedge | 5/ 62 (8 %) | 3/ 13 (23 %) | 2/ 49 (4 %) | |
| Navicular Replacement Cage | 4/ 62 (7 %) | 2/ 13 (15 %) | 2/ 49 (4 %) | |
| Talus Replacing Sphere | 23/ 62 (37 %) | 2/ 13 (15 %) | 21/ 49 (43 %) | |
| Tibial and Talar Replacement Tower | 15/ 62 (24 %) | 6/ 13 (46 %) | 9/ 49 (18 %) | |
| Tibial Replacement Tower | 9/ 62 (15 %) | 0/ 13 (0 %) | 9/ 49 (18 %) | |
| Lattice Type | ||||
| Truss | 21/ 62 (34 %) | 8/ 13 (62 %) | 13/ 49 (27 %) | 0.017* |
| Gyroid | 41/ 62 (66 %) | 5/ 13 (38 %) | 36/ 49 (73 %) | |
| Evidence of Radiographic Osseointegration at 6 months (N = 60) | ||||
| No | 15/ 60 (25 %) | 5/ 12 (42 %) | 10/ 48 (21 %) | 0.153 |
| Yes | 45/ 60 (75 %) | 7/ 12 (58 %) | 38/ 48 (79 %) | |
| Evidence of Radiographic Osseointegration at 1 year (N = 46) | ||||
| No | 7/ 46 (15 %) | 2/ 9 (22 %) | 5/ 37 (14 %) | 0.609 |
| Yes | 39/ 46 (85 %) | 7/ 9 (78 %) | 32/ 37 (86 %) | |
| Evidence of Radiographic Osseointegration at 2 years (N = 39) | ||||
| No | 3/ 39 (8 %) | 1/ 8 (12 %) | 2/ 31 (6 %) | 0.508 |
| Yes | 36/ 39 (92 %) | 7/ 8 (88 %) | 29/ 94 (86 %) | |
| Superficial Wound Breakdown | ||||
| No | 47/ 62 (76 %) | 6/ 13 (46 %) | 41/ 49 (84 %) | 0.005* |
| Yes | 15/ 62 (24 %) | 7/ 13 (54 %) | 8/ 49 (16 %) | |
| Implant Removal | ||||
| No | 50/ 62 (81 %) | 3/ 13 (23 %) | 47/ 49 (96 %) | < 0.001* |
| Yes | 12/ 62 (19 %) | 10/ 13 (77 %) | 2/ 49 (4 %) | |
| Amputation Required | ||||
| No | 57/ 62 (92 %) | 10/ 13 (77 %) | 47/ 49 (96 %) | 0.058 |
| Yes | 5/ 62 (8 %) | 3/ 13 (23 %) | 2/ 49 (4 %) | |
Legend: A breakdown of preoperative, perioperative, and postoperative variables evaluated by this study. Results are categorized into overall cohort, and infection status post index surgery. Asterisk (*) indicates statistical significance with a p-value < 0.05.
Flowchart of patient inclusion. Legend: overview flowsheet of number of cases included in the final study cohort and infections after index surgery.
The infection rate in the overall cohort was 21 % (13). Time to infection ranged widely with a median of 957.0 days [IQR 159.0, 1711.0]. Demographics, BMI, prior foot and ankle surgeries, and defect size were not significantly different between groups nor were history of diabetes, smoking, neuropathy, and prior foot and ankle infection. Evidence of radiographic osseointegration was not significantly different between cohorts at any time point.
There was a significant difference in infection rates for each implant type, with 46 % (6/13) of the infection cohort having a tibial and talar replacement tower compared to 18 % in the non-infection cohort (9/49). The talus replacing sphere was the most used implant type in 37 % of the overall cohort, 15 % of the infection cohort, and 43 % in the non-infection cohort. Lattice type used was significantly different between groups, with the gyroid lattice being used in 73 % of the non-infection cohort and only 38 % of the infection cohort (p = 0.017). SWB, defined as surgical wound breakdowns, was significantly different between groups, with 54 % of the infection cohort having breakdown compared to 16 % in the non-infection cohort. 77 % of the infection cohort underwent implant removal compared to only 4 % of the non-infection cohort (p < 0.001). Similarly, amputation was required in 23 % of the infection cohort, while only 4 % of the non-infection cohort underwent amputation (p = 0.058).
3.2
Overall demographic details by infection timeline
A full breakdown of demographic details and perioperative variables based on time to infection presentation can be found in Table 2 . Overall, 13 patients from the infection cohort were included in this table, with 2 (15 %) experiencing early infection (≤3 months), 4 (31 %) experiencing delayed infection (>3 months and ≤24 months), and 7 (54 %) experiencing late infection (>24 months). Past medical history of neuropathy was found to be statistically significant (p = 0.013) with positive history found in 50 % of early infection patients, 100 % in delayed infection patients, and 14 % in late infection patients. No other variables were statistically significant.
Table 2
Sub-analysis of cohort by timing of infection.
| Variable | Overall (N = 13) | Infection Timing | p-value | ||
|---|---|---|---|---|---|
| Early Infection (≤90 Days) (N = 2) | Delayed Infection (>90 and ≤730 Days) (N = 4) | Late Infection (>730 Days) (N = 7) | |||
| Age (years) | 55.0 (52.0, 62.0) | 40.0 (32.5, 47.5) | 56.5 (54.2, 62.8) | 59.0 (48.0, 64.5) | 0.431 |
| BMI (kg/m 2 ) | 34.7 (31.5, 42.0) | 35.6 (32.4, 38.8) | 33.2 (30.6, 35.5) | 34.7 (33.6, 43.2) | 0.676 |
| Follow-up Time |
1935.0
(1084.0, 2601.0) |
800.0
(658.0, 942.0) |
1282.5
(779.8, 1840.0) |
2601.0
(1978.0, 2663.5) |
0.046* |
| Number of Prior Foot/Ankle Surgeries | 3.0 (1.0, 3.0) | 5.0 (2.5, 7.5) | 3.0 (2.2, 3.8) | 2.0 (1.5, 3.0) | 0.841 |
| Defect Size (cm 2 ) | 5.3 (3.9, 10.5) | 7.9 (6.6, 9.2) | 9.8 (5.6, 13.1) | 4.0 (3.8, 5.9) | 0.519 |
| Time to infection (days) |
957.0
(159.0, 1711.0) |
55.0
(48.0, 62.0) |
248.5
(157.0, 358.5) |
1711.0
(1324.5, 2038.0) |
0.007* |
| Sex | |||||
| Female | 5/ 13 (38 %) | 1/ 2 (50 %) | 1/ 4 (25 %) | 3/ 7 (43 %) | 1.000 |
| Male | 8/ 13 (62 %) | 1/ 2 (50 %) | 3/ 4 (75 %) | 4/ 7 (57 %) | |
| Race | |||||
| American Indian or Native Alaskan | 1/ 13 (8 %) | 0/ 2 (0 %) | 1/ 4 (25 %) | 0/ 7 (0 %) | 0.115 |
| Asian | 0/ 13 (0 %) | 0/ 2 (0 %) | 0/ 4 (0 %) | 0/ 7 (0 %) | |
| Black/African American | 1/ 13 (8 %) | 1/ 2 (50 %) | 0/ 4 (0 %) | 0/ 7 (0 %) | |
| Caucasian/White | 11/ 13 (85 %) | 1/ 2 (50 %) | 3/ 4 (75 %) | 7/ 7 (100 %) | |
| Not Reported | 0/ 13 (0 %) | 0/ 2 (0 %) | 0/ 4 (0 %) | 0/ 7 (0 %) | |
| Ethnicity | |||||
| Hispanic/Latino | 0/ 13 (0 %) | 0/ 2 (0 %) | 0/ 4 (0 %) | 0/ 7 (0 %) | 0.154 |
| Not Hispanic/Latino | 12/ 13 (92 %) | 1/ 2 (50 %) | 4/ 4 (100 %) | 7/ 7 (100 %) | |
| Not Reported | 1/ 13 (8 %) | 1/ 2 (50 %) | 0/ 4 (0 %) | 0/ 7 (0 %) | |
| History of Diabetes | |||||
| No | 6/ 13 (46 %) | 1/ 2 (50 %) | 1/ 4 (25 %) | 4/ 7 (57 %) | 0.755 |
| Yes | 7/ 13 (54 %) | 1/ 2 (50 %) | 3/ 4 (75 %) | 3/ 7 (43 %) | |
| History of Smoking | |||||
| No | 9/ 13 (69 %) | 0/ 2 (0 %) | 4/ 4 (100 %) | 5/ 7 (71 %) | 0.050 |
| Yes | 4/ 13 (31 %) | 2/ 2 (100 %) | 0/ 4 (0 %) | 2/ 7 (29 %) | |
| History of Neuropathy | |||||
| No | 7/ 13 (54 %) | 1/ 2 (50 %) | 0/ 4 (0 %) | 6/ 7 (86 %) | 0.013* |
| Yes | 6/ 13 (46 %) | 1/ 2 (50 %) | 4/ 4 (100 %) | 1/ 7 (14 %) | |
| History of Prior Foot/Ankle Surgery | |||||
| No | 3/ 13 (23 %) | 1/ 2 (50 %) | 1/ 4 (25 %) | 1/ 7 (14 %) | 0.706 |
| Yes | 10/ 13 (77 %) | 1/ 2 (50 %) | 3/ 4 (75 %) | 6/ 7 (86 %) | |
| History of Infection | |||||
| No | 11/ 13 (85 %) | 2/ 2 (100 %) | 4/ 4 (100 %) | 5/ 7 (71 %) | 0.641 |
| Yes | 2/ 13 (15 %) | 0/ 2 (0 %) | 0/ 4 (0 %) | 2/ 7 (29 %) | |
| Reason for Index Operation | |||||
| Avascular Necrosis | 0/ 13 (0 %) | 0/ 2 (0 %) | 0/ 4 (0 %) | 0/ 7 (0 %) | 0.885 |
| Charcot Deformities | 6/ 13 (46 %) | 1/ 2 (50 %) | 3/ 4 (75 %) | 2/ 7 (29 %) | |
| Failed Arthrodesis | 3/ 13 (23 %) | 0/ 2 (0 %) | 1/ 4 (25 %) | 2/ 7 (29 %) | |
| Failed TAR | 0/ 13 (0 %) | 0/ 2 (0 %) | 0/ 4 (0 %) | 0/ 7 (0 %) | |
| Post Reconstruction Defects | 1/ 13 (8 %) | 0/ 2 (0 %) | 0/ 4 (0 %) | 1/ 7 (14 %) | |
| Traumatic Defects/Deformities | 3/ 13 (23 %) | 1/ 2 (50 %) | 0/ 4 (0 %) | 2/ 7 (29 %) | |
| Implant Type | |||||
| Hindfoot Wedge | 0/ 13 (0 %) | 0/ 2 (0 %) | 0/ 4 (0 %) | 0/ 7 (0 %) | 0.762 |
| Intratibial Cage | 0/ 13 (0 %) | 0/ 2 (0 %) | 0/ 4 (0 %) | 0/ 7 (0 %) | |
| Midfoot Wedge | 3/ 13 (23 %) | 0/ 2 (0 %) | 1/ 4 (25 %) | 2/ 7 (29 %) | |
| Navicular Replacement Cage | 2/ 13 (15 %) | 0/ 2 (0 %) | 0/ 4 (0 %) | 2/ 7 (29 %) | |
| Talus Replacing Sphere | 2/ 13 (15 %) | 1/ 2 (50 %) | 0/ 4 (0 %) | 1/ 7 (14 %) | |
| Tibial and Talar Replacement Tower | 6/ 13 (46 %) | 1/ 2 (50 %) | 3/ 4 (75 %) | 2/ 7 (29 %) | |
| Tibial Replacement Tower | 0/ 13 (0 %) | 0/ 2 (0 %) | 0/ 4 (0 %) | 0/ 7 (0 %) | |
| Lattice Type | |||||
| Truss | 8/ 13 (62 %) | 2/ 2 (100 %) | 1/ 4 (25 %) | 5/ 7 (71 %) | 0.315 |
| Gyroid | 5/ 13 (38 %) | 0/ 2 (0 %) | 3/ 4 (75 %) | 2/ 7 (29 %) | |
| Evidence of Radiographic Osseointegration at 6 months (N = 12) | |||||
| No | 5/ 12 (42 %) | 1/ 1 (100 %) | 2/ 4 (50 %) | 2/ 7 (29 %) | 0.381 |
| Yes | 7/ 12 (58 %) | 0/ 1 (0 %) | 2/ 4 (50 %) | 5/ 7 (71 %) | |
| Evidence of Radiographic Osseointegration at 1 year (N = 9) | |||||
| No | 2/ 9 (22 %) | – | 0/ 2 (0 %) | 2/ 7 (29 %) | 1.000 |
| Yes | 7/ 9 (78 %) | – | 2/ 2 (100 %) | 5/ 7 (71 %) | |
| Evidence of Radiographic Osseointegration at 2 years (N = 8) | |||||
| No | 1/ 8 (12 %) | – | 0/ 2 (0 %) | 1/ 6 (17 %) | 1.000 |
| Yes | 7/ 8 (88 %) | – | 2/ 2 (100 %) | 5/ 6 (83 %) | |
| Superficial Wound Breakdown | |||||
| No | 6/ 13 (46 %) | 0/ 2 (0 %) | 3/ 4 (75 %) | 3/ 7 (43 %) | 0.372 |
| Yes | 7/ 13 (54 %) | 2/ 2 (100 %) | 1/ 4 (25 %) | 4/ 7 (57 %) | |
| Implant Removal | |||||
| No | 3/ 13 (23 %) | 0/ 2 (0 %) | 0/ 4 (0 %) | 2/ 7 (43 %) | 0.217 |
| Yes | 10/ 13 (77 %) | 2/ 2 (100 %) | 4/ 4 (100 %) | 5/ 7 (57 %) | |
| Amputation Required | |||||
| No | 10/ 13 (77 %) | 1/ 2 (50 %) | 2/ 4 (50 %) | 7/ 7 (100 %) | 0.094 |
| Yes | 3/ 13 (23 %) | 1/ 2 (50 %) | 2/ 4 (50 %) | 0/ 7 (0 %) | |
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