Ir J Med Sci DOI 10.1007/s11845-013-1032-9
ORIGINAL ARTICLE
A treatment for large defects of the tibia caused by infected nonunion: Ilizarov method with bone segment extension K. Xu • X. Fu • Y.-M. Li • C.-G. Wang Z.-J. Li
•
Received: 15 October 2012 / Accepted: 17 October 2013 Ó Royal Academy of Medicine in Ireland 2013
Abstract Objectives To investigate the efficacy of the Ilizarov technique with bone segment extension in tibial infected nonunion. Methods From September 2003 to June 2011, we treated 30 patients (21 males, 9 females; age 19–49 years, mean 34.1 years) for tibial infected nonunion with bone defects. Eleven cases were compound fractures internally fixed with steel plates, nine were compound fractures internally fixed with IM Nails, eight were compound fractures externally fixed with external fixation devices, and two were closed fractures internally fixed with steel plates. All 30 patients underwent debridement followed by the Ilizarov technique using bone segment extension. Results After follow-up of 12 months–6 years (mean 29 months), stable union of fracture was achieved in all 30 patients. The time from bone fracture to union was 6–24 months, mean 8.8 months; external fixation was in place for 8–14 months, mean 10 months. External fixation K. Xu and X. Fu contributed equally to this study. K. Xu C.-G. Wang Z.-J. Li (&) Department of Orthopedic Surgery, Tianjin Medical University General Hospital, No. 154 Anshan Road, Tianjin 300052, China e-mail: [email protected] X. Fu Department of Orthopedics, Tianjin Hospital, Tianjin 300211, China Y.-M. Li Department of Rehabilitation, Tianjin Hospital, Tianjin 300211, China Z.-J. Li Immunology Department, Tianjin Medical University, No. 22 Qixiangtai Road, Tianjin 300070, China
index was 41 days/cm. Complications were three cases of pin site infection, one skin allergy, two fractures malunion, one early mineralization and one wire breakage. There were no cases of deep infection, nonunion or stiffness of the knee joint. According to the Paley fracture healing score criteria, 30 cases had excellent outcomes and two were good. Conclusions The Ilizarov technique with bone segment extension is effective in treating tibial infected nonunion with large bone defects. Keywords External fixation Ilizarov technique Infected nonunion
Introduction Infected nonunion (INU) of the tibia is common in clinical practice and can lead to bone and soft tissue defects, longterm nonunion and disuse of the limb, and even amputation in severe cases. The incidence of INU of open fracture is increasing, and more than 50 % of cases occur after internal fixation [1]. In the past, open or closed bone graft was used to treat INU, but this was associated with severe operative wounds, poor clinic efficacy, and complications such as nonunion and malunion [2]. Severe trauma, postoperative infection and repeated operations usually lead to large local bone defects, which make treatment difficult. In 1951 in the former USSR, Gavriil Abramovich Ilizarov devised the Ilizarov external fixation technique, which now plays an indispensable role in the treatment of open fracture, delayed union and nonunion, and in limb lengthening. It can also increase the stability of fractures and improve early weight-bearing. More recently, interest is increasing in the use of the Ilizarov external fixation technique to treat INU by extension of bone segments [3]. The aim of this study was to
123
Ir J Med Sci Table 1 Clinical data of the patients before the treatment Case
Sex
Age (years)
Infected condition The length of bone defect (cm)
Jain type
Skin defect (cm 9 cm)
Number of previous tibial surgeries
Time of previous treatment (months)
1
M
22
9
A2
0
3
6
2
M
42
8
B2
396
11
8
3 4
M M
24 46
9 7
B2 B2
193 293
4 7
7 10
5
M
40
3
B1
291
5
8
6
M
19
9
B2
596
10
24
7
M
23
12
B2
795
14
6
8
F
28
6
A2
293
7
6
9
M
28
5
B2
492
8
10
10
F
37
5
A2
0
3
8
11
M
26
5
B2
192
5
7
12
M
23
3
B1
192
4
13
13
F
40
6
A2
0
3
10
14
M
49
6
A2
0
3
7
15
F
34
7
B2
293
5
9
16
F
43
6
B2
193
6
6
17
M
22
5
A2
0
3
8
18 19
M F
45 37
9 3
B2 B1
393 192
7 7
7 6
20
M
28
10
B2
394
9
9
21
M
41
6
A2
0
3
6
22
F
42
4
A2
0
3
7
23
F
40
3
A2
0
4
8
24
M
39
6
B1
192
5
9
25
M
37
6
B1
192
6
10
26
M
35
7
B2
293
6
9
27
M
28
8
B1
291
4
8
28
M
27
9
B2
293
5
12
29
M
40
5
B1
291
4
9
30
F
39
6
B2
393
6
10
investigate the efficacy of the Ilizarov technique in treating INU with bone transport.
Patients and methods Thirty patients (21 male, 9 female; mean age 34.1 years, range 19–49 years) were involved in this study. Fracture had occurred in the proximal tibia in eight cases, in the middle tibia in fourteen cases and in the distal tibia in eight cases. The INU followed compound fracture fixed internally with steel plates in eleven cases, compound fracture fixed internally with IM Nails in nine cases, compound fracture fixed externally with an external fixation device in eight cases, and closed fracture fixed internally with steel plates in two cases. The mean time from the original injury to treatment for INU
123
was 6–24 months, means 8.8 months, during which the patients had undergone a mean of six operations (range 3–14). None of the patients had diabetes mellitus, heart or lung dysfunction, or any other severe medical condition. According to the bone defect and infection classification proposed by Jain and Sinha [4], nine cases were type A2 (resting infection, fracture gap after debridement \4 cm), seven cases were type B1 (active infection, fracture gap after debridement \4 cm) and fourteen cases were type B2 (active infection, fracture gap after debridement [4 cm). Sinuses had formed in 8 cases and bone was exposed in 22 cases; the largest area of exposed bone was approximately 7 9 5 cm and the smallest areas were approximately 2 9 1 cm. The length of the bone defects after debridement was 3–12 cm (mean 6.4 cm). The patients’ clinical data are summarized in Table 1.
Ir J Med Sci
All patients underwent a full physical examination, including tests for diabetes mellitus, malnutrition and anemia. Local examination was conducted, paying attention to the blood supply to the soft tissue, the size of the bone defect and the stability of the fracture ends. With the aid of X-ray films, we determined the location and type of fracture, the presence or absence of sequestrum and its size and location, and the size of the bone defect. Samples of wound secretions were taken for culture and drug susceptibility tests, according to the results of which appropriate antibiotics were administered for 1 week. Surgery was performed under lumbar epidural anesthesia. The aim of the operation was debridement and to obtain free drainage. After removal of the original internal fixation, necrotic tissue was removed, sequestrum resected until errhysis occurred at the broken ends of the bone, and dead space obliterated. In resting infection (type A) cases, we use the patients’ original soft tissue to cover the wound. In patients with severe defects that were barely covered by this means, temporary shortening was taken from the area of the fracture to obtain adequate soft tissue. To avoid interference with the leg’s blood supply, the shortening was usually less than 20 % of the limb’s length. In active infection (type B) cases, dressings were changed, drainage was obtained and antibiotics given following debridement. When active infection was controlled, a segment of bone for excision was obtained by osteotomy. The site and extent of the bone defect was taken into consideration when choosing the osteotomy site. For the tibia, we generally prefer the distal and proximal metaphyses. Osteotomy at the diaphysis of the tibia, which has a relatively poor blood supply, is considered only when osteotomy at the metaphysis is not possible. After surgery, the patients were given antibiotics for 1 week and began functional exercise early. Extension began 7 days [5] after the operation. Ilizarov external fixation devices were supplied by Yian Lifang, Beijing, China. In most cases, four to six extensions of 1 mm in 1 day were required to extend the bone segment. X-ray films were taken every 4 weeks to enable timely modifications to the extension and reshaping program. When the extended bone segment was in contact with the distal end of the fractured bone, we adjusted its position and direction and began gradually to exert pressure on the segment to stabilize the join. The Ilizarov external fixation device cannot be removed until callus mineralization has occurred in the extended segment and bone union has been achieved where the two ends of the fracture meet. Patients should bear weight completely for 2–4 weeks before the fixation is removed. On the day of removal, the patient should loosen the external fixation and attempt to walk, to assess the reliability of the bone union. We determined the clinical facture healing time according to follow-up X-ray examinations, and recorded
postoperative complications such as deep infection, skin necrosis and malunion. We evaluated the fracture union according to Paley’s fracture union score criteria [6], as follows: excellent (fracture union without recurrent infection, local deformity \7° and leg length discrepancy \2.5 cm); good (fracture union with one or two of the three conditions above); bad (disunion of fracture or refracture, or all three of the conditions above).
Results All 30 patients were followed up for 12 months–6 years, mean approximately 29 months. In all patients, stable fracture union was achieved. They were in hospital for 1–5 months, mean length of stay 1.8 months. The time taken for fracture union was 6–24 months, mean 8.8 months; external fixation was in place for 8–14 months, mean 10 months. External fixation index was 41 days/cm. According to Paley’s fracture union score criteria, 30 cases were excellent and two cases were good. A typical case is illustrated in Fig. 1. Complications included three cases of superficial pin site infection, which was cured by local care, weight reduction and oral antibiotics. Skin allergy occurred in one patient and was treated with oral antihistamine drugs. Malunion occurred in two patients and was cured by a second osteotomy and reshaping. Early mineralization occurred in one case, but satisfactory union was achieved after a second osteotomy. In one case, wire breakage required re-pinning and further fixation. There were no cases of deep infection, nonunion or dysfunction of the knee joint. The result is summarized in Table 2.
Discussion INU is a fracture that has not achieved union after 6–8 months with persistent local infection. The infection produces a microenvironment that inhibits bone regeneration, reduces the stability of internal fixation, and significantly delays or inhibits fracture union [7]. INU may occur after open fracture or following internal fixation of fracture. An open fracture may lead to INU when the cause is a high-energy injury with a severe soft tissue defect and damage to the blood supply. With the proliferation of the use of internal fixation in recent years, INU following internal fixation now comprises more than 50 % of cases. Manifestations of INU include formation of sequestrum when the blood supply is interrupted, liquor puris, and positive bacterial cultures of samples taken from deep sites. INU often associated with complications such as cutaneous deficiency, osteoporosis, joint stiffness and leg length
123
Ir J Med Sci
Fig. 1 Serial radiographs illustrating the Ilizarov method using bone segment extension for the treatment of infected nonunion of the tibia with a large bone defect (10 cm) in a 28-year-old man. a Anteroposterior (AP) radiograph of the tibial open fracture and the appearance of the right leg of the patient. b The operation of debridement, bone
osteotomy and the supply of Ilizarov external fixation. c AP radiograph showing bone transport by the Ilizarov method. d AP radiography showing bone healing after 11 months. e AP radiograph of the tibia after removal of the external fixation and the appearance of the right leg
discrepancy, and infection with drug resistant bacteria. All of these problems make treatment of INU difficult [8]. According to May [9], the size of the bone defect and whether the fibula is intact can be used to classify tibial osteomyelitis and guide its treatment. When the bone defect is less than 6 cm, bone graft can be used. When the bone defect is larger than 6 cm, a graft would not only need a large amount of bone, but also have to be protected for a long period of time to prevent fragmentation during bony remodeling. The goal of treatment of tibial INU is to restore the lines of force and achieve fracture union with a painless and functional limb [10]. Traditional treatments, including open or closed bone grafting with autogenous bone, heterobone or artificial bone, are suitable for bone defects of approximately 3–4 cm. Such procedures are simple to perform with few complications, can be conducted in one operation, and can serve as an emergency measure before another technique. However, there are limitations. To avoid
re-fracture before complete corticalization has occurred, protection is needed for a long period of time until the grafted bone is established. Furthermore, the operation causes great trauma and has low efficacy, often resulting in nonunion, delayed union or malunion [11]. Distraction osteogenesis was first devised in the 1950s. Distraction leads to compensatory proliferation of muscle, fascia, nerves and skin, after which neoplastic bone mineralizes through membrane bone formation. Normal bone structure is achieved by stimulation in the form of the application of physical stress, and the broken ends of the fractured bone achieve union through bone remodeling. The Ilizarov extension technique solves some of the difficulties of treating nonunion and malunion of long bones and bone defects [12], and corrects bone defects and limb shortening at the same time [13]. In theory, the Ilizarov technique is suitable for bone defects of any length, with advantages such as little trauma,
123
Ir J Med Sci Table 2 Results Case
The time of follow-up (months)
The time in hospital (months)
1
12
1
6
8
2
24
1.5
7
13
3 4
22 30
2 1
9 6
11 8
30 25.8
5
32
1
6
8
60
None
Excellent
6
36
2
9
10
30
None
Excellent
7
72
5
12
14
30
Pin site infection and lateral angulation
Good
8
24
1
8
10
40
None
Excellent
9
36
1.5
7
8
42
None
Excellent
10
32
1
8
9
48
None
Excellent
11
28
1.5
8
9
48
None
Excellent
12
36
1
7
8
70
None
Excellent
13
24
2.5
7
9
35
Mineralization in advance
Excellent
14 15
24 24
1 1.5
9 9
10 11
45 38.6
Skin allergy None
Excellent Excellent
16
28
2
8
9
40
None
Excellent
17
28
1.5
7
9
42
None
Excellent
18
36
2.5
8
10
26.7
Pin site infection
Excellent
19
32
1
6
8
60
None
Excellent
20
36
3
11
13
33
Lateral angulation
Good
21
24
1.5
7
9
35
None
Excellent
22
24
2
7
9
52.5
None
Excellent
23
28
2.5
Excellent
24
24
2
25
32
26 27
The time of fracture union (months)
The time of external fixation (months)
External fixation index (days/cm)
Complication
Paley score
20.1
None
Excellent
26.3
Breaking of needle
Excellent
None Pin site infection
Excellent Excellent
8
10
80
None
11
14
55
None
Excellent
1.5
8
10
40
None
Excellent
16
1
9
12
38.6
None
Excellent
18
2.5
7
9
26.3
None
Excellent
28
22
2
6
10
20
None
Excellent
29 30
24 26
1 2
8 9
10 12
48 45
None None
Excellent Excellent
stable fixation and early activity [14, 15]. It is also easy to monitor and treat the injury and any infection. However, the join is easily re-fractured if healing takes a long time, the quality of the union is poor or bone remodeling is slow. To promote bone union, the join faces can be debrided and pruned when necessary to improve the contact area. In the present study, three patients required such treatment. In two cases, this was because of invagination and incarceration of scarred skin at the fracture ends. The other case was due to a lack of sufficient contact area for union. Important aspects of the Ilizarov technique are as follows. (1) Due to the requirement for a stable fixation structure, the tension of the fine tensioned wires used should be appropriate to their diameter and maintained throughout the procedure. (2) Extension of the bone segment should begin 7 days [5] after osteotomy, and X-ray
films should be obtained to verify the stability of the external fixation and the traction on the segment, such that any structural defect can be corrected promptly. (3) X-ray examination should be performed monthly to monitor the distraction and the joining of the fractured bone. The state of mineralization of the distracted area should be noted and the extension and reshaping program adjusted as necessary to correct deformities and promote the recovery of limb function. 4) Functional exercise is needed after the operation. Patients can undertake partial weight-bearing activities during the extension phase. Extension is followed by initial and later phases of callus mineralization. During the initial phase, when the density is lower than normal, patients can gradually increase their activity and degree of weight-bearing. During the late phase of callus mineralization, when the density is normal, patients can gradually
123
Ir J Med Sci
attain full weight-bearing; 4–8 weeks later, removal of the external fixation can be attempted. For Ilizarov external fixation, fine tensioned wires of diameter 2 mm and tension 1,000–2,000 N are recommended. Rigid fixation can be achieved using four of these, each in the distal and proximal fracture ends. By this means, a stable biomechanical environment can be created for bone formation and union. However, the steel can become fatigued in use, leading to breakage of needles during the middle or later phases of bone transport and mineralization [16]. One case of wire breakage occurred in this study, in the internal posterior part of the proximal fractured bone, which has a large range of motion. Because the callus in this case had almost reached the later mineralization phase, there was no need to change the needle. Pin site infection [17] usually occurs in areas where there is a greater range of motion and high stress. Tensioned wires provide the best drainage, and free drainage generally will prevent deep infection. Pin site infection occurred in three cases in this group but was managed by changing the dressing. Early mineralization of the extended bone segment occurs when the osteotomy was incomplete or the distraction stress inadequate during the early extension phase. This complication should be considered when large changes are observed in the length of the extended segment and the distance between the broken ends of the fractured bone. Repeated osteotomy at the site of the original procedure is needed. One case in this study required a second osteotomy 2 weeks after the extension began, with a favorable result after the operation. Malunion of the extended segment is usually caused by failure promptly to correct residual deformity during the middle or late extension phase, when joining occurs. Two patients in this group missed a scheduled follow-up appointment and were found to have malunion in the late phase of callus mineralization, with lateral angulation of 9°. The deformity was corrected by a second osteotomy. In summary, in INU, union can be achieved only after local infection is controlled, free drainage is obtained, necrotic tissue has been removed from the nidus, and a stable biomechanical and biological environment has been created. Treatment of INU by the Ilizarov technique using bone segment extension has many advantages. The procedure is simple with few complications, allows early functional exercise, promotes functional recovery of the knee and ankle joints, and reduces disease associated with fracture. With a skilled surgeon, careful postoperative
123
management and guided functional exercise for the patient, this technique may be an effective treatment for tibial INU. Acknowledgments The authors did not receive grants or funding in support or preparation of this article. No commercial entity paid or directed any benefits to any research fund, educational institution, or nonprofit organization with which the authors are affiliated or associated. Conflict of interest
None.
References 1. Gualdrini G, Stagni C, Fravisini M, Giunti A (2002) Infected nonunion of the femur. Chir Organi Mov 87:225–233 2. Motsitsi NS (2008) Management of infected nonunion of long bones: the last decade (1996–2006). Injury 39:155–160 3. Farmanullah, Khan MS, Awais SM (2007) Evaluation of management of tibial non-union defect with Ilizarov fixator. J Ayub Med Coll Abbottabad 19:34–36 4. Jain AK, Sinha S (2005), Infected nonunion of the long bones. Clin Orthop Relat Res 431:57–65 5. Kim H et al (2009) Tibial lengthening using a reamed type intramedullary nail and an Ilizarov external fixator. Int Orthop 33:835–841 6. Paley D et al. (1989) Ilizarov treatment of tibial nonunions with bone loss. Clin Orthop Relat Res 241:146–165 7. Rodriguez-Merchan EC, Forriol F (2004) Nonunion: general principles and experimental data. Clin Orthop Relat Res 418:4–12 8. Patzakis MJ, Zalavras CG (2005) Chronic posttraumatic osteomyelitis and infected nonunion of the tibia: current management concepts. J Am Acad Orthop Surg 13:417–427 9. May JW Jr, Jupiter JB, Weiland AJ, Byrd HS (1989) Clinical classification of post-traumatic tibial osteomyelitis. J Bone Joint Surg Am 71:1422–1428 10. Mechrefe AP, Koh EY, Trafton PG, DiGiovanni CW (2006) Tibial nonunion. Foot Ankle Clin 11:1–18 11. Lazzarini L, Mader JT, Calhoun JH (2004) Osteomyelitis in long bones. J Bone Joint Surg Am 86-A:2305–2318 12. Ilizarov GA (1989) The tension-stress effect on the genesis and growth of tissues. Part I. The influence of stability of fixation and soft-tissue preservation. Clin Orthop Relat Res 238:249–281 13. Abdel-Aal AM (2006) Ilizarov bone transport for massive tibial bone defects. Orthopedics 29:70–74 14. Saridis A et al (2006) The use of the Ilizarov method as a salvage procedure in infected nonunion of the distal femur with bone loss. J Bone Joint Surg Br 88:232–237 15. Ilizarov GA (1990) Clinical application of the tension-stress effect for limb lengthening. Clin Orthop Relat Res 250:8–26 16. Mullins MM, Davidson AW, Goodier D, Barry M (2003) The biomechanics of wire fixation in the Ilizarov system. Injury 34:155–157 17. Green SA, Jackson JM, Wall DM, Marinow H, Ishkanian J (1992) Management of segmental defects by the Ilizarov intercalary bone transport method. Clin Orthop Relat Res 280:136–142
ORIGINAL ARTICLE
A treatment for large defects of the tibia caused by infected nonunion: Ilizarov method with bone segment extension K. Xu • X. Fu • Y.-M. Li • C.-G. Wang Z.-J. Li
•
Received: 15 October 2012 / Accepted: 17 October 2013 Ó Royal Academy of Medicine in Ireland 2013
Abstract Objectives To investigate the efficacy of the Ilizarov technique with bone segment extension in tibial infected nonunion. Methods From September 2003 to June 2011, we treated 30 patients (21 males, 9 females; age 19–49 years, mean 34.1 years) for tibial infected nonunion with bone defects. Eleven cases were compound fractures internally fixed with steel plates, nine were compound fractures internally fixed with IM Nails, eight were compound fractures externally fixed with external fixation devices, and two were closed fractures internally fixed with steel plates. All 30 patients underwent debridement followed by the Ilizarov technique using bone segment extension. Results After follow-up of 12 months–6 years (mean 29 months), stable union of fracture was achieved in all 30 patients. The time from bone fracture to union was 6–24 months, mean 8.8 months; external fixation was in place for 8–14 months, mean 10 months. External fixation K. Xu and X. Fu contributed equally to this study. K. Xu C.-G. Wang Z.-J. Li (&) Department of Orthopedic Surgery, Tianjin Medical University General Hospital, No. 154 Anshan Road, Tianjin 300052, China e-mail: [email protected] X. Fu Department of Orthopedics, Tianjin Hospital, Tianjin 300211, China Y.-M. Li Department of Rehabilitation, Tianjin Hospital, Tianjin 300211, China Z.-J. Li Immunology Department, Tianjin Medical University, No. 22 Qixiangtai Road, Tianjin 300070, China
index was 41 days/cm. Complications were three cases of pin site infection, one skin allergy, two fractures malunion, one early mineralization and one wire breakage. There were no cases of deep infection, nonunion or stiffness of the knee joint. According to the Paley fracture healing score criteria, 30 cases had excellent outcomes and two were good. Conclusions The Ilizarov technique with bone segment extension is effective in treating tibial infected nonunion with large bone defects. Keywords External fixation Ilizarov technique Infected nonunion
Introduction Infected nonunion (INU) of the tibia is common in clinical practice and can lead to bone and soft tissue defects, longterm nonunion and disuse of the limb, and even amputation in severe cases. The incidence of INU of open fracture is increasing, and more than 50 % of cases occur after internal fixation [1]. In the past, open or closed bone graft was used to treat INU, but this was associated with severe operative wounds, poor clinic efficacy, and complications such as nonunion and malunion [2]. Severe trauma, postoperative infection and repeated operations usually lead to large local bone defects, which make treatment difficult. In 1951 in the former USSR, Gavriil Abramovich Ilizarov devised the Ilizarov external fixation technique, which now plays an indispensable role in the treatment of open fracture, delayed union and nonunion, and in limb lengthening. It can also increase the stability of fractures and improve early weight-bearing. More recently, interest is increasing in the use of the Ilizarov external fixation technique to treat INU by extension of bone segments [3]. The aim of this study was to
123
Ir J Med Sci Table 1 Clinical data of the patients before the treatment Case
Sex
Age (years)
Infected condition The length of bone defect (cm)
Jain type
Skin defect (cm 9 cm)
Number of previous tibial surgeries
Time of previous treatment (months)
1
M
22
9
A2
0
3
6
2
M
42
8
B2
396
11
8
3 4
M M
24 46
9 7
B2 B2
193 293
4 7
7 10
5
M
40
3
B1
291
5
8
6
M
19
9
B2
596
10
24
7
M
23
12
B2
795
14
6
8
F
28
6
A2
293
7
6
9
M
28
5
B2
492
8
10
10
F
37
5
A2
0
3
8
11
M
26
5
B2
192
5
7
12
M
23
3
B1
192
4
13
13
F
40
6
A2
0
3
10
14
M
49
6
A2
0
3
7
15
F
34
7
B2
293
5
9
16
F
43
6
B2
193
6
6
17
M
22
5
A2
0
3
8
18 19
M F
45 37
9 3
B2 B1
393 192
7 7
7 6
20
M
28
10
B2
394
9
9
21
M
41
6
A2
0
3
6
22
F
42
4
A2
0
3
7
23
F
40
3
A2
0
4
8
24
M
39
6
B1
192
5
9
25
M
37
6
B1
192
6
10
26
M
35
7
B2
293
6
9
27
M
28
8
B1
291
4
8
28
M
27
9
B2
293
5
12
29
M
40
5
B1
291
4
9
30
F
39
6
B2
393
6
10
investigate the efficacy of the Ilizarov technique in treating INU with bone transport.
Patients and methods Thirty patients (21 male, 9 female; mean age 34.1 years, range 19–49 years) were involved in this study. Fracture had occurred in the proximal tibia in eight cases, in the middle tibia in fourteen cases and in the distal tibia in eight cases. The INU followed compound fracture fixed internally with steel plates in eleven cases, compound fracture fixed internally with IM Nails in nine cases, compound fracture fixed externally with an external fixation device in eight cases, and closed fracture fixed internally with steel plates in two cases. The mean time from the original injury to treatment for INU
123
was 6–24 months, means 8.8 months, during which the patients had undergone a mean of six operations (range 3–14). None of the patients had diabetes mellitus, heart or lung dysfunction, or any other severe medical condition. According to the bone defect and infection classification proposed by Jain and Sinha [4], nine cases were type A2 (resting infection, fracture gap after debridement \4 cm), seven cases were type B1 (active infection, fracture gap after debridement \4 cm) and fourteen cases were type B2 (active infection, fracture gap after debridement [4 cm). Sinuses had formed in 8 cases and bone was exposed in 22 cases; the largest area of exposed bone was approximately 7 9 5 cm and the smallest areas were approximately 2 9 1 cm. The length of the bone defects after debridement was 3–12 cm (mean 6.4 cm). The patients’ clinical data are summarized in Table 1.
Ir J Med Sci
All patients underwent a full physical examination, including tests for diabetes mellitus, malnutrition and anemia. Local examination was conducted, paying attention to the blood supply to the soft tissue, the size of the bone defect and the stability of the fracture ends. With the aid of X-ray films, we determined the location and type of fracture, the presence or absence of sequestrum and its size and location, and the size of the bone defect. Samples of wound secretions were taken for culture and drug susceptibility tests, according to the results of which appropriate antibiotics were administered for 1 week. Surgery was performed under lumbar epidural anesthesia. The aim of the operation was debridement and to obtain free drainage. After removal of the original internal fixation, necrotic tissue was removed, sequestrum resected until errhysis occurred at the broken ends of the bone, and dead space obliterated. In resting infection (type A) cases, we use the patients’ original soft tissue to cover the wound. In patients with severe defects that were barely covered by this means, temporary shortening was taken from the area of the fracture to obtain adequate soft tissue. To avoid interference with the leg’s blood supply, the shortening was usually less than 20 % of the limb’s length. In active infection (type B) cases, dressings were changed, drainage was obtained and antibiotics given following debridement. When active infection was controlled, a segment of bone for excision was obtained by osteotomy. The site and extent of the bone defect was taken into consideration when choosing the osteotomy site. For the tibia, we generally prefer the distal and proximal metaphyses. Osteotomy at the diaphysis of the tibia, which has a relatively poor blood supply, is considered only when osteotomy at the metaphysis is not possible. After surgery, the patients were given antibiotics for 1 week and began functional exercise early. Extension began 7 days [5] after the operation. Ilizarov external fixation devices were supplied by Yian Lifang, Beijing, China. In most cases, four to six extensions of 1 mm in 1 day were required to extend the bone segment. X-ray films were taken every 4 weeks to enable timely modifications to the extension and reshaping program. When the extended bone segment was in contact with the distal end of the fractured bone, we adjusted its position and direction and began gradually to exert pressure on the segment to stabilize the join. The Ilizarov external fixation device cannot be removed until callus mineralization has occurred in the extended segment and bone union has been achieved where the two ends of the fracture meet. Patients should bear weight completely for 2–4 weeks before the fixation is removed. On the day of removal, the patient should loosen the external fixation and attempt to walk, to assess the reliability of the bone union. We determined the clinical facture healing time according to follow-up X-ray examinations, and recorded
postoperative complications such as deep infection, skin necrosis and malunion. We evaluated the fracture union according to Paley’s fracture union score criteria [6], as follows: excellent (fracture union without recurrent infection, local deformity \7° and leg length discrepancy \2.5 cm); good (fracture union with one or two of the three conditions above); bad (disunion of fracture or refracture, or all three of the conditions above).
Results All 30 patients were followed up for 12 months–6 years, mean approximately 29 months. In all patients, stable fracture union was achieved. They were in hospital for 1–5 months, mean length of stay 1.8 months. The time taken for fracture union was 6–24 months, mean 8.8 months; external fixation was in place for 8–14 months, mean 10 months. External fixation index was 41 days/cm. According to Paley’s fracture union score criteria, 30 cases were excellent and two cases were good. A typical case is illustrated in Fig. 1. Complications included three cases of superficial pin site infection, which was cured by local care, weight reduction and oral antibiotics. Skin allergy occurred in one patient and was treated with oral antihistamine drugs. Malunion occurred in two patients and was cured by a second osteotomy and reshaping. Early mineralization occurred in one case, but satisfactory union was achieved after a second osteotomy. In one case, wire breakage required re-pinning and further fixation. There were no cases of deep infection, nonunion or dysfunction of the knee joint. The result is summarized in Table 2.
Discussion INU is a fracture that has not achieved union after 6–8 months with persistent local infection. The infection produces a microenvironment that inhibits bone regeneration, reduces the stability of internal fixation, and significantly delays or inhibits fracture union [7]. INU may occur after open fracture or following internal fixation of fracture. An open fracture may lead to INU when the cause is a high-energy injury with a severe soft tissue defect and damage to the blood supply. With the proliferation of the use of internal fixation in recent years, INU following internal fixation now comprises more than 50 % of cases. Manifestations of INU include formation of sequestrum when the blood supply is interrupted, liquor puris, and positive bacterial cultures of samples taken from deep sites. INU often associated with complications such as cutaneous deficiency, osteoporosis, joint stiffness and leg length
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Fig. 1 Serial radiographs illustrating the Ilizarov method using bone segment extension for the treatment of infected nonunion of the tibia with a large bone defect (10 cm) in a 28-year-old man. a Anteroposterior (AP) radiograph of the tibial open fracture and the appearance of the right leg of the patient. b The operation of debridement, bone
osteotomy and the supply of Ilizarov external fixation. c AP radiograph showing bone transport by the Ilizarov method. d AP radiography showing bone healing after 11 months. e AP radiograph of the tibia after removal of the external fixation and the appearance of the right leg
discrepancy, and infection with drug resistant bacteria. All of these problems make treatment of INU difficult [8]. According to May [9], the size of the bone defect and whether the fibula is intact can be used to classify tibial osteomyelitis and guide its treatment. When the bone defect is less than 6 cm, bone graft can be used. When the bone defect is larger than 6 cm, a graft would not only need a large amount of bone, but also have to be protected for a long period of time to prevent fragmentation during bony remodeling. The goal of treatment of tibial INU is to restore the lines of force and achieve fracture union with a painless and functional limb [10]. Traditional treatments, including open or closed bone grafting with autogenous bone, heterobone or artificial bone, are suitable for bone defects of approximately 3–4 cm. Such procedures are simple to perform with few complications, can be conducted in one operation, and can serve as an emergency measure before another technique. However, there are limitations. To avoid
re-fracture before complete corticalization has occurred, protection is needed for a long period of time until the grafted bone is established. Furthermore, the operation causes great trauma and has low efficacy, often resulting in nonunion, delayed union or malunion [11]. Distraction osteogenesis was first devised in the 1950s. Distraction leads to compensatory proliferation of muscle, fascia, nerves and skin, after which neoplastic bone mineralizes through membrane bone formation. Normal bone structure is achieved by stimulation in the form of the application of physical stress, and the broken ends of the fractured bone achieve union through bone remodeling. The Ilizarov extension technique solves some of the difficulties of treating nonunion and malunion of long bones and bone defects [12], and corrects bone defects and limb shortening at the same time [13]. In theory, the Ilizarov technique is suitable for bone defects of any length, with advantages such as little trauma,
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Ir J Med Sci Table 2 Results Case
The time of follow-up (months)
The time in hospital (months)
1
12
1
6
8
2
24
1.5
7
13
3 4
22 30
2 1
9 6
11 8
30 25.8
5
32
1
6
8
60
None
Excellent
6
36
2
9
10
30
None
Excellent
7
72
5
12
14
30
Pin site infection and lateral angulation
Good
8
24
1
8
10
40
None
Excellent
9
36
1.5
7
8
42
None
Excellent
10
32
1
8
9
48
None
Excellent
11
28
1.5
8
9
48
None
Excellent
12
36
1
7
8
70
None
Excellent
13
24
2.5
7
9
35
Mineralization in advance
Excellent
14 15
24 24
1 1.5
9 9
10 11
45 38.6
Skin allergy None
Excellent Excellent
16
28
2
8
9
40
None
Excellent
17
28
1.5
7
9
42
None
Excellent
18
36
2.5
8
10
26.7
Pin site infection
Excellent
19
32
1
6
8
60
None
Excellent
20
36
3
11
13
33
Lateral angulation
Good
21
24
1.5
7
9
35
None
Excellent
22
24
2
7
9
52.5
None
Excellent
23
28
2.5
Excellent
24
24
2
25
32
26 27
The time of fracture union (months)
The time of external fixation (months)
External fixation index (days/cm)
Complication
Paley score
20.1
None
Excellent
26.3
Breaking of needle
Excellent
None Pin site infection
Excellent Excellent
8
10
80
None
11
14
55
None
Excellent
1.5
8
10
40
None
Excellent
16
1
9
12
38.6
None
Excellent
18
2.5
7
9
26.3
None
Excellent
28
22
2
6
10
20
None
Excellent
29 30
24 26
1 2
8 9
10 12
48 45
None None
Excellent Excellent
stable fixation and early activity [14, 15]. It is also easy to monitor and treat the injury and any infection. However, the join is easily re-fractured if healing takes a long time, the quality of the union is poor or bone remodeling is slow. To promote bone union, the join faces can be debrided and pruned when necessary to improve the contact area. In the present study, three patients required such treatment. In two cases, this was because of invagination and incarceration of scarred skin at the fracture ends. The other case was due to a lack of sufficient contact area for union. Important aspects of the Ilizarov technique are as follows. (1) Due to the requirement for a stable fixation structure, the tension of the fine tensioned wires used should be appropriate to their diameter and maintained throughout the procedure. (2) Extension of the bone segment should begin 7 days [5] after osteotomy, and X-ray
films should be obtained to verify the stability of the external fixation and the traction on the segment, such that any structural defect can be corrected promptly. (3) X-ray examination should be performed monthly to monitor the distraction and the joining of the fractured bone. The state of mineralization of the distracted area should be noted and the extension and reshaping program adjusted as necessary to correct deformities and promote the recovery of limb function. 4) Functional exercise is needed after the operation. Patients can undertake partial weight-bearing activities during the extension phase. Extension is followed by initial and later phases of callus mineralization. During the initial phase, when the density is lower than normal, patients can gradually increase their activity and degree of weight-bearing. During the late phase of callus mineralization, when the density is normal, patients can gradually
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attain full weight-bearing; 4–8 weeks later, removal of the external fixation can be attempted. For Ilizarov external fixation, fine tensioned wires of diameter 2 mm and tension 1,000–2,000 N are recommended. Rigid fixation can be achieved using four of these, each in the distal and proximal fracture ends. By this means, a stable biomechanical environment can be created for bone formation and union. However, the steel can become fatigued in use, leading to breakage of needles during the middle or later phases of bone transport and mineralization [16]. One case of wire breakage occurred in this study, in the internal posterior part of the proximal fractured bone, which has a large range of motion. Because the callus in this case had almost reached the later mineralization phase, there was no need to change the needle. Pin site infection [17] usually occurs in areas where there is a greater range of motion and high stress. Tensioned wires provide the best drainage, and free drainage generally will prevent deep infection. Pin site infection occurred in three cases in this group but was managed by changing the dressing. Early mineralization of the extended bone segment occurs when the osteotomy was incomplete or the distraction stress inadequate during the early extension phase. This complication should be considered when large changes are observed in the length of the extended segment and the distance between the broken ends of the fractured bone. Repeated osteotomy at the site of the original procedure is needed. One case in this study required a second osteotomy 2 weeks after the extension began, with a favorable result after the operation. Malunion of the extended segment is usually caused by failure promptly to correct residual deformity during the middle or late extension phase, when joining occurs. Two patients in this group missed a scheduled follow-up appointment and were found to have malunion in the late phase of callus mineralization, with lateral angulation of 9°. The deformity was corrected by a second osteotomy. In summary, in INU, union can be achieved only after local infection is controlled, free drainage is obtained, necrotic tissue has been removed from the nidus, and a stable biomechanical and biological environment has been created. Treatment of INU by the Ilizarov technique using bone segment extension has many advantages. The procedure is simple with few complications, allows early functional exercise, promotes functional recovery of the knee and ankle joints, and reduces disease associated with fracture. With a skilled surgeon, careful postoperative
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management and guided functional exercise for the patient, this technique may be an effective treatment for tibial INU. Acknowledgments The authors did not receive grants or funding in support or preparation of this article. No commercial entity paid or directed any benefits to any research fund, educational institution, or nonprofit organization with which the authors are affiliated or associated. Conflict of interest
None.
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