Participants
We identified 22 patients according to our inclusion criteria. Eighteen patients returned the questionnaires. Of the four non-responders, one patient had died, one was not able to respond because of a mental disorder, and two were not interested in responding. All data concerning descriptive information on the patient sample are shown in Table 1. Moreover, results concerning occupational outcomes of surgery are the following. Before their trauma, 11.1% of patients were pensioners, 22.2% were unemployed, and 67.5% were employed. Of those who were employed, 37.5% returned to work. After returning to work, 50% of the patients had persistent symptoms and 50% reported limitations at work due to their injuries.
Table 1 Descriptive data of the study cohort.
Continuous variables
|
|
Mean
|
SD
|
Range
|
Age (years)
|
58.0
|
15.9
|
17 - 81
|
BMI (kg/m2)
|
27.6
|
6.5
|
19.1 – 42.5
|
Categorical variables
|
|
|
N1
|
%
|
Sex
|
m
|
14
|
63.6
|
f
|
8
|
36.4
|
Smoking
|
Y
|
12
|
54.5
|
N
|
10
|
45.5
|
Substance Abuse
|
Y
|
8
|
36.4
|
N
|
14
|
63.6
|
Diabetes Mellitus
|
Y
|
5
|
22.7
|
N
|
17
|
77.3
|
Comorbidities
|
None
|
7
|
31.8
|
1 – 3
|
10
|
45.5
|
4 – 5
|
4
|
18.2
|
> 6
|
1
|
4.5
|
Abbreviations: BMI = body mass index; f = female; m = male; N1 = number; N = no; SD = standard deviation; Y= yes.
Fracture types and complications
Fractures were classified according to the AO/OTA classification and to the criteria by Gustilo and Anderson [5]. Fracture classification and primarily used flaps are shown in Table 2.
Table 2 Classification of fractures.
|
|
N1
|
%
|
Classification AO/OTA
|
44 A1
|
3
|
13.6
|
44 A2
|
2
|
9.1
|
44 A3
|
1
|
4.5
|
44 B1
|
3
|
13.6
|
44 B3
|
5
|
22.7
|
44 C2
|
1
|
4.5
|
43 A3
|
3
|
13.6
|
43 C3
|
3
|
13.6
|
43 C1
|
1
|
4.5
|
Open fracture
|
Y
|
11
|
50
|
N
|
11
|
50
|
G&A Classification
|
1
|
0
|
0
|
2
|
3
|
13.6
|
3a
|
2
|
9.1
|
3b
|
6
|
27.3
|
Flaps
|
ALT
|
15
|
68.3
|
|
Latissimus dorsi
|
5
|
22.7
|
|
TDAP
|
1
|
4.5
|
|
Soleus
|
1
|
4.5
|
Abbreviations: AO/OTA = Arbeitsgemeinschaft für Osteosynthesefragen; ALT = anterolateral thigh flap; G&A = Gustilo and Anderson; N1 = number; TDAP = thoracodorsal artery perforator; N = no, Y = yes.
All closed fractures developed necrosis and surgical site infection (SSI) and required subsequent revisions and debridement, resulting in larger soft tissue defects. In 15 of 17 instances of SSI, bacterial contamination was detected (Table 3).
Table 3 Complications and infections.
Complication
|
|
N1
|
%
|
Osteosynthesis
|
Y
|
17
|
77.3
|
N
|
5
|
22.7
|
Flap ischemia
|
Y
|
13
|
59.1
|
N
|
9
|
40.9
|
SSI
|
Y
|
22
|
100
|
N
|
0
|
0
|
Early SSI
|
Y
|
12
|
54.5
|
N
|
10
|
45.5
|
Late SSI
|
Y
|
10
|
45.5
|
N
|
12
|
54.5
|
Bacterium
|
Staph. aureus
|
4
|
18.2
|
Staph. epidermidis
|
3
|
13.6
|
Staph. capitis
|
1
|
4.5
|
Strep. pyogenes
|
1
|
4.5
|
E1. coli
|
1
|
4.5
|
E2. faecalis
|
1
|
4.5
|
E3. cloacae
|
3
|
13.6
|
Bacillus cereus
|
1
|
4.5
|
no bacterial detection
|
7
|
31.8
|
Abbreviation: E1 = Escherichia; E2 = Enterococcus; E3 = Enterobacter; N1 = number; N = no; SSI = surgical site infection; Staph = Staphylococcus; Strep = Streptococcus; Y = yes.
Preoperatively, interventional arteriography was performed in 16 patients and Duplex ultrasound of the venous system was performed in six of those 16 patients without findings of thrombosis. In seven patients, adequate circulation in all three arteries of the lower leg was found. In five patients, arterial stenosis was treated by balloon dilation. A venous bypass graft was applied in one patient. In three patients, treatment with angiography and recanalization via stenting of the occlusion was performed after loss of the first flap. Complications occurred in 12 flaps; in 10 of those cases, the flap was lost due to perfusion problems and necrosis. As a result, revision flap coverage was required. The mean number of revision surgeries was 7.63 ± 4.98 (range 2 – 22). None of our patients reported problems at the donor sites after soft tissue grafts such as wound healing disorders, pain, or mobility limitations.
Patient-reported outcomes
The results of FAOS and EQ-5D are given in Table 4. Most patient complaints were revealed in the “quality of life” subscore (mean score 32.3) (p>0.05). The “symptoms” subscore mean was moderate at 60.1 (p>0.05), and patients were bothered the least by pain with a mean score of 73.6 (p>0.05).
Table 4 Outcomes: FAOS, FAOS subscores, and EQ-5D VAS scores.
|
Mean
|
SD
|
Minimum
|
Maximum
|
FAOS
|
60.7
|
22.2
|
27.00
|
100
|
Symptoms
|
60.1
|
27.5
|
21.43
|
100
|
Pain
|
73.6
|
23.0
|
30.56
|
100
|
ADL
|
66.9
|
19.7
|
38.24
|
100
|
Sport/Rec
|
40.4
|
39.1
|
0.0
|
100
|
QoL
|
32.3
|
28.8
|
0.0
|
100
|
EQ-5D VAS
|
57.7
|
20.2
|
30.00
|
100
|
EQ-5D index
|
0.6215
|
0.279
|
0.13
|
1
|
Abbreviations: ADL = activities of daily living; FAOS = Foot and Ankle Outcome Score; QoL = quality of life; SD = standard deviation; Sport/Rec: function in sports and recreational activities; VAS = visual analog scale.
Two patients with amputations were included in the follow-up. One of those two patients underwent bilateral amputation after 22 revision surgeries; he reported an EQ-5D VAS of 50 and an EQ-5D index of 0.26. The other patient experienced bilateral trauma and underwent direct amputation on one side and seven surgeries on the other side; he reported an EQ-5D VAS of 80 and an EQ-5D index of 0.91.
Furthermore, we analyzed the outcome of the 10 patients with flap ischemia in comparison with the other patients. In our follow-up examinations we determined that patients with flap ischemia had poorer outcomes than patients without ischemic complications. Detailed FAOS subscores and EQ-5D VAS related to ischemic and non-ischemic groups are shown in Table 5. Patients with ischemia were found to be lower in all subscores compared to patients without ischemia. The lowest subscore was QoL (mean 21.88) (p>0.05).
Table 5 Ischemia of flaps.
|
yes
|
no
|
|
|
Mean
|
Minimum
|
Maximum
|
SD
|
Mean
|
Minimum
|
Maximum
|
SD
|
p
|
Follow-up time in months
|
43.50
|
26.00
|
80.00
|
18.27
|
39.42
|
22.00
|
84.00
|
17.39
|
|
Pain
|
69.45
|
30.56
|
94.44
|
26.47
|
77.78
|
47.22
|
100.00
|
20.64
|
0.6
|
Symptoms
|
46.43
|
25.00
|
71.43
|
19.56
|
73.81
|
21.43
|
100.00
|
28.72
|
0.08
|
ADL
|
61.52
|
38.24
|
94.12
|
19.50
|
72.31
|
38.24
|
100.00
|
20.04
|
0.4
|
Sport/Rec
|
29.17
|
5.00
|
85.00
|
34.56
|
51.67
|
0.00
|
105.00
|
43.09
|
0.3
|
QoL
|
21.88
|
0.00
|
56.25
|
20.44
|
42.71
|
6.25
|
100.00
|
33.87
|
0.2
|
FAOS
|
53.00
|
27.00
|
81.00
|
20.09
|
68.33
|
31.00
|
100.00
|
23.32
|
0.3
|
EQ-5D VAS
|
59.17
|
35.00
|
100.00
|
25.38
|
56.43
|
30.00
|
80.00
|
16.51
|
0.8
|
Abbreviations: ADL = activities of daily living; FAOS = Foot and Ankle Outcome Score; QoL = quality of life; SD = standard deviation; Sport/Rec: function in sports and recreational activities; VAS = visual analog scale.