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Infected segmental bone defects (I-SBD) are challenging and complex to manage. This study aimed to show the outcomes achieved in I-SBD of the femur and tibia, treated with the induced membrane technique performing a definitive bone stabilization in the first stage.
Methods
We retrospectively reviewed 30 patients with infected non-articular segmental bone defects of the femur (n = 11) and tibia (n = 19), operated consecutively between January 2015 and May 2021. The need for fixation exchange, bone defect length, allo/autograft ratio used, bone healing, reoperation (discriminating between mechanical and infection-related causes), and failure rates (graft resorption or nonunion) were recorded.
Results
Fixation in the first stage was performed with 28 (93.33%) intramedullary nails, ten coated with antibiotic cement, and 2 (6.67%) locked plates. None were removed during the second stage of the technique. The mean length of the bone defects was 5cm (range 3.5–12). The most commonly used allo-/autograft ratio was 50-50. The bone healing rate was 93.33% (n = 28), with a median follow-up of 7 months (range 3–12). The reoperation rate due to mechanical instability was 3.33% (n = 1) and for recurrence of infection was 10.0% (n = 3). The overall failure rate was 6.67% (n = 2). The median follow-up was 42 months (range 12–85).
Conclusion
Masquelet technique appears feasible and effective in treating infected segmental bone defects of the femur and tibia. Definitive fixation at the first stage showed a success rate of 93.33%, with a re-operation rate of 10.0% related to infection.
Fracture-Related Infection (FRI) consensus group. Evidence-based recommendations for local antimicrobial strategies and dead space management in fracture-related infection.
It consists of a thorough surgical debridement, the placement of a cement spacer to fill the bone defect (around which a reactive membrane will grow), and its stabilization with external fixation. In the second stage, the spacer is removed, the lesion is definitively stabilized, and the defect is filled with an autologous cancellous bone graft.
Masquelet technique in post-traumatic infected femoral and tibial segmental bone defects. Union and reoperation rates with high proportions (up to 64%) of allograft in the second stage.
It has been mostly reported in aseptic bone defects, showing certain benefits such as not hindering the performance of soft tissue coverage, avoiding the associated risk of pin tract infection, allowing early rehabilitation, and decreasing bone healing time.
There have been few reports on this modification technique in I-SBD, perhaps due to the possibility of biofilm formation around the implant and the risk of infection recurrence.
Therefore, this study aimed to assess the results regarding bone healing, reoperations, and failure rates in treating infected segmental bone defects of the femur and tibia with the induced membrane technique, performing a definitive bone fixation in the first stage.
1.1 Methods
We retrospectively reviewed our department's database, identifying all consecutive patients treated between January 2012 and May 2021 with the Masquelet technique for a femoral or tibial segmental bone defect. This study was carried out after obtaining approval from the ethics committee of our hospital (Protocol number 7517).
The inclusion criteria were patients older than 18 years with I-SBD who underwent definitive fixation at the first stage of the Masquelet technique. Patients with aseptic bone defects, bone defects secondary to oncological resection, articular bone defects, and those who did not fulfill a minimum follow-up of 12 months from the second stage were excluded.
The defect was considered infected in the presence of two positive cultures with the same microorganism of two intraoperative bone samples or the presence of a positive culture together with the presence of a fistula or intraoperative pus.
Overall, based on the inclusion and exclusion criteria, 30 of 57 patients were eligible to participate (27 were excluded: 6 had aseptic bone defects, ten had not completed both stages of treatment, seven did not achieve the minimum follow-up, two because the defect had been due to oncological resection, one because definitive stabilization wasn't performed in the first stage, and one because the bone defect affected the distal epiphysis of the femur).
The study population included 30 patients, 21 men and nine women, with a median age of 40 years (range 18–68). Bone defects affected the femur in 11 (36.67%) cases and the tibia in 19 (63.33%). Patient descriptions are summarized in Table 1.
Table 1Patients’ demographics, preoperative data and first stage result.
Patients
Gender/Age
Comorb
Injury (bone Gustillo)
Time from injury to Masquelt (months)
Prev surg
Fixation method (first stage)
ATB spacer
Soft tissue coverage
1
M 62
–
F
14
1
Plate
V
–
2
F 45
–
T
9
3
Plate
V
–
3
M 40
–
F
13
3
A-IMN
VG
–
4
F 65
F
17
3
IMN
V
–
5
M 60
F
16
5
IMN
V
–
6
F 47
F
13
2
IMN
V
–
7
F 60
S
F
21
1
IMN
V
–
8
F 18
DM
F
32
3
IMN
V
–
9
M 19
–
F–3B
24
1
IMN
V
–
10
M 23
O
F-3A
16
2
A-IMN
VG
–
11
M 41
–
F-2
8
4
A-IMN
VG
12
M 23
–
F
9
5
IMN
VG
–
13
M 36
S
T-3B
8
3
IMN
V
Cross-leg
14
M 18
–
T-2
12
2
IMN
V
–
15
M 40
–
T 3B
20
7
IMN
V
VAC, skin graft
16
M 68
DM
T
9
6
A-IMN
VG
VAC, skin graft
17
M 51
–
T-3A
16
2
A-IMN
V
LMF
18
M 18
T-2
9
5
IMN
T
VAC, skin graft
19
F 24
S
T-3A
2
2
IMN
V
LMF
20
M 35
–
T-2
16
2
IMN
V
LMF
21
M 64
–
T-3A
27
3
A-IMN
VG
22
M 45
–
T-3B
12
3
IMN
VG
LMF
23
M 34
–
T-3B
21
3
IMN
V
VAC, cross-leg
24
F 41
–
T
16
2
IMN
V
–
25
F 47
–
T-3B
12
2
A-IMN
V
LMF
26
M 18
–
T
12
2
A-IMN
V
–
27
M 19
S
T-3A
7
3
IMN
VG
LMF
28
M 47
–
T-3A
10
3
A-IMN
VG
LMF
29
M 32
–
T-3B
11
4
IMN
VG
LMF
30
M 35
–
T-3A
12
2
A-IMN
VG
LMF
F: female; M: male T: tibia; F: femur; S: smoking; DM: diabetes mellitus; O: Obesity – Body Mass Index >30; Prev surg: number of surgeries previous to Masquelet technique, IMN: intramedullary nail; A-IMN: intramedullary nail coated with antibiotic cement; Plate: two locked plates; V: vancomycin, G: gentamicin; GV: gentamicin + vancomycin; T: tobramycin; LMF: local muscle flap; VAC: vacuum-assistance closure .
First stage: the previous osteosynthesis was removed entirely. An aggressive debridement with resection of all infected/dead bone and soft tissues was performed until a vital surgical bed and bleeding bone ends were obtained. The medullary canal was reamed and flushed. Bone and soft tissue samples were sent for bacteriological (at least 5) and histological analysis (at least 3). According to the location of the bone defect, an intramedullary nail or a locked plate, restoring alignment, length, and rotation of the limb was used for fixation. In cases where a nail was implanted, it was statically locked with the appropriate diameter and length to yield a definitive fixation. In patients with plate fixation and with the same goal, a minimum of three locked screws were placed on each side of the defect. Then, it was filled with surgical cement (adding 2 g of antibiotic per dose) (Fig. 1). Primary wound closure, or if necessary, an appropriate soft tissue coverage procedure, was performed.
Fig. 1a: Intraoperative image showing ATB-nail fixation at the first stage. B: cement spacer placement around the intramedullary nail.
After this stage, progressive weight-bearing was allowed according to tolerance, using crutches. The patients received empirical broad-spectrum intravenous antibiotic (ATB) therapy until microbiological sensitivity results were obtained, at which time they were shifted to a specific ATB regimen. Then, they continued oral treatment, as indicated and monitored by the infectious disease department.
Second stage: The second stage was performed after an ATB-free period of two weeks. The spacer was explanted, and the bony ends of the defect were curetted. We also used this second time to remove non-viable tissue and repeat sampling for microbiology. We then grafted the defect using autograft (harvested from the homolateral iliac crest) and allograft. The latter was provided by the institution's bone and tissue bank. It was delivered to the operating room, morselized, defatted, frozen, and non-irradiated. The amounts and proportions of allo-autograft used were systematically recorded in each surgery. Specific flasks tabulated in cubic centimeters were used for this purpose. Finally, the induced membrane was hermetically closed.
Postoperatively, immediate weight-bearing was allowed, according to the progression of the clinical and radiological signs of bone healing.
Postoperative clinical and radiological follow-up examinations were performed every two weeks after the first stage and at three weeks, 3, 6, 12, 18, and 24 months, continuing annually after that.
1.3 Data
From the first stage, we recorded information regarding the type of implant used for definitive fixation, ATB added to cement spacer, and soft tissue coverage procedures (if any). The results of surgical samples sent for bacteriological or histological analysis, reoperations, and the time elapsed between stages were also registered.
In the second stage, we analyzed the size of the bone defect and the need for exchange or augmentation (addition of a locked plate) of the osteosynthesis implanted at the first stage. We also recorded the allo-autograft ratio used and the bone healing time.
The need for reoperations and their cause (mechanical and infection-related causes), healing, and failure rate were registered at the end of the study. We used the WOMAC score
Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee.
(by telephone interview at the close of the study) to assess the functional outcomes.
Bone healing was defined when 3 of 4 cortices showed bone bridges joining the ends of the defect on postoperative anteroposterior (AP) and lateral (L) radiographs, with the absence of pain under weight-bearing.
Infection remission was defined as the absence of clinical (discharge, warm skin, swelling, pain) and radiological signs/symptoms related to infection, together with normalization of erythrocyte sedimentation rate and C reactive protein values.
Masquelet technique in post-traumatic infected femoral and tibial segmental bone defects. Union and reoperation rates with high proportions (up to 64%) of allograft in the second stage.
A descriptive analysis of the series was performed. Continuous variables were expressed as mean and standard deviation or median and range according to their distribution. Categorical variables were expressed as frequency and percentage.
1.5 Results
Locked plates were used in two (6.67%) cases and intramedullary nails in 28 (93.33%) cases (of which ten - 40% - were coated with ATB cement) for bone fixation on the first stage.
Vancomycin was the most frequent ATB added to the spacer in 18 (60.00%) patients. (Table 1). Fourteen (46.67%) cases needed soft tissue coverage reconstructions.
Staphylococcus aureus was the most frequently (36.67%) isolated microorganism from intraoperative samples (Table 2). Four (13.33%) patients had negative cultures, three had an active fistula, and all had intraoperative pus. Histological findings compatible with infection were observed in all patients.
Table 2Microbiology, defect size, grafting, and outcomes.
Fracture-Related Infection (FRI) consensus group. Evidence-based recommendations for local antimicrobial strategies and dead space management in fracture-related infection.
Fracture-Related Infection (FRI) consensus group. Evidence-based recommendations for local antimicrobial strategies and dead space management in fracture-related infection.
: PA + CNS. Allo: auto %: allograft/autograft proportion; Reop infection: reoperation related to infection; Reop instability: reoperation related to mechanical instability; Y: yes; Failure: non-union or bone resorption.
The median time between stages was nine weeks (range 6–28). The median length of the bone defect was 5 cm (range 3.5–14).
One patient treated with a retrograde nail for a bone defect in the distal third of the femoral shaft needed augmentation with a locked plate in the second stage. There were no cases where the fixation implanted in the first stage was removed.
The most frequent allo-autograft proportion used was 50-50 in 12 (40%) cases. Lower ratios were used in 5 (16.67%) and higher in 13 (43.33%) cases. (Table 2).
1.6 Outcomes
1.6.1 Bone healing
The bone healing rate was 93.33% (n = 28), at a median of 7 months (range 3–12). In 27 (90.0%) cases, it was achieved without reoperation (Fig. 2).
Fig. 2Patient number 21. a-b: Radiographs showing an infected non-union of the tibia with nail failure. c-d: AP and L radiographs after the first stage, showing ATB cement-coated nail fixation and space placement. e-f: Radiographs at months 1 and 6 after the second stage, with a 50-50 auto-allograft ratio. g-h: AP and L radiograph 22 months after the second stage, showing bony healing.
Fig. 2Patient number 21. a-b: Radiographs showing an infected non-union of the tibia with nail failure. c-d: AP and L radiographs after the first stage, showing ATB cement-coated nail fixation and space placement. e-f: Radiographs at months 1 and 6 after the second stage, with a 50-50 auto-allograft ratio. g-h: AP and L radiograph 22 months after the second stage, showing bony healing.
The overall reoperations rate was 13.33% (n = 4), of which 3.33% (n = 1) was related to mechanical instability, and 10.0% (n = 3) was related to infection.
1.6.3 Reoperations related to instability
In a metaphyseal-diaphyseal defect of the proximal tibia patient, which had been fixed with a nail, mobility at the defect site was found five months after the second stage. Stability augmentation with a locked plate was performed, achieving bone healing three months later.
1.6.4 Reoperations related to infection
In one case, it was necessary to repeat the first stage three weeks after spacer placement due to the persistence of the infection. This case was treated with nail and spacer removal, surgical debridement, reaming, and fixation with an ATB-cement-coated nail.
Infection recurrence was registered in two patients at months 8 and 15 after the second stage. As bone healing was observed in both cases, they were treated with nail removal, reaming, placement of an ATB-cement-coated nail, and systemic ATB therapy (Fig. 3). Both were able to control the infection until the end of the study.
Fig. 3Patient number 19. a-b: Radiographs showing segmental tibial fracture with a bony defect. c-d-e: Intraoperative images of the first stage showing cement spacer and soft tissue coverage. f-g: Immediate postoperative AP-L radiographs showing nail fixation and cannulated screw for the medial malleolus fracture. h-i: Immediate postoperative AP-L radiographs of the second stage. j-k: AP and L radiographs showing bone healing at 6.5 months. At month 8, the patient experienced a recurrence of infection (see description in text), so an ATB-coated nail was implanted. l-m: Radiograph showing postoperative bone remodeling at 23 months.
Fig. 3Patient number 19. a-b: Radiographs showing segmental tibial fracture with a bony defect. c-d-e: Intraoperative images of the first stage showing cement spacer and soft tissue coverage. f-g: Immediate postoperative AP-L radiographs showing nail fixation and cannulated screw for the medial malleolus fracture. h-i: Immediate postoperative AP-L radiographs of the second stage. j-k: AP and L radiographs showing bone healing at 6.5 months. At month 8, the patient experienced a recurrence of infection (see description in text), so an ATB-coated nail was implanted. l-m: Radiograph showing postoperative bone remodeling at 23 months.
The failure rate was 6.67% (n = 2). One patient suffered nail breakage due to non-union 20 months after the second stage. This patient was treated with a larger diameter reamed nail replacement, achieving bone healing eight months after surgery. The second failure was a patient with a femoral defect initially stabilized with a nail. Thirteen months after the second stage (at the time of the study closure), the patient showed no radiological evidence of bone healing. As the infection was controlled and he was walking pain-free with a cane, the patient refused further surgery.
1.6.6 Follow-up and functional outcomes
The median follow-up after the second stage was 42 (range 12–85) months. At the end of the study, all patients were walking without pain, and one was using a cane. The median WOMAC score was 75 (range: 55–87).
2. Discussion
The main finding of this study was that with definitive fixation in the first stage of the induced membrane technique, we achieved 93.33% of bone healing, with a reoperation rate due to recurrence or lack of infection control of 10.0%.
We understand that in I-SBD, performing definitive fixation in the first stage may potentially increase the risk of infection recurrence, as reported by Bose et al..
Treatment of infected non-unions of the femur and tibia in a French referral center for complex bone and joint infections: outcomes of 55 patients after 2 to 11 years.
and based on the outcomes of this study, we believe that if the initial debridement and soft tissue coverage are proper, this risk does not appear to be increased. Comparing the results of the present study with others in which stabilization in the first stage was performed with external fixations, we observed that the rate of reoperations due to infection was similar. Masquelet et al.
who reported bone union and infection recurrence rates of 91.6% and 41%, respectively. The authors associated their reoperation rate due to infection with insufficient initial debridement, an issue widely established as one of the main risk factors for recurrence.
We agree that this could have been the reoperation causes in our series, being more evident in the early repetition of the first stage of the technique. In addition, the use of ATB in the spacer may have masked the infection, leading to late recurrences.
reported a series of patients stabilized with nails in the first stage, in which 37.5% had I-SBD. They reported higher percentages than those obtained in our study, with 100% bone healing and no recurrence, highlighting the advantages of rehabilitation and early return to the patient's daily activities.
found no significant difference regarding complication rates when comparing patients treated with a combined fixation (external fixator + plate or nail) against patients stabilized with external fixation alone. In another study, Wang et al.
identified plate fixation and the need for several debridements before the second stage as risk factors for the recurrence of infection. Neither of the two cases with plate fixation was revised in our series.
that definitive bone stabilization in the first stage offers the possibility of immediate weight-bearing after each stage and avoids the discomfort generated by external fixation, especially in this type of injury, which usually entails long treatment periods. In addition, possible iatrogenic injury to the membrane when removing the temporary fixation would be avoided.
Another highlight in this study is related to the proportion of allograft used (between 40 and 65%) to fill the bone defect. Traditionally, the use of autograft has been described as completing the remaining volume with allograft (as an expander) in proportions that do not exceed 3:1.
in a systematic review and meta-analysis, described the different types of graft, proportions, and combinations used in 17 studies. They highlight that bone union and reoperation rates did not correlate with the types of grafts used. In our opinion, this shows the technique's versatility and the lack of consensus on this issue. Finally, our rate of bone healing was like the ones reported in two recent meta-analyses, in which a rate of 89.7% and 92.35% were informed.
Therefore, the allograft ratios used in the present study appear to be a realistic alternative.
We believe our results are based on respecting and following critical concepts in treating these injuries. Such as achieving an infection-free environment, mainly through an aggressive surgical debridement. Also, by providing adequate soft tissue coverage and an optimal biomechanical environment using stable fixation from the first stage. Finally, filling the bone defect with autograft provides cellularity and its properties (osteogenic, osteoinductive, osteoconductive), together with the osteoconduction provided by the allograft. All of this converges on the closed and richly vascularized space inside the membrane, which provides angiogenic and osteoblastic factors that allow the creation of a microenvironment to promote bone healing.
The weaknesses of our study are related to its retrospective design and the number of patients. Another weakness is the absence of a control group, which could have provided greater power to our findings. All these difficulties have been hard to avoid due to the complexity present in each patient. Nevertheless, the authors believe this study could contribute to the current knowledge and a better understanding of the technique.
3. Conclusions
Treatment of infected segmental bone defects of the femur and tibia with the Masquelet technique appears feasible and effective. Definitive fixation in the first stage showed a success rate of 93.33%, with a reoperation rate of 10.0% related to infection, confirming the already reported versatility of the technique.
Funding
This research did not receive any specific grant from funding agencies in the public, commercial or not-profit sectors.
Ethics
This retrospective chart review study, involving human participants, was in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments. The Bioethics Committee of British Hospital of Buenos Aires approved this study (Protocol number 7517).
Consent to participate
Informed consent was obtained from all individual participants included in the study.
Availability of data and material
All data generated and analyzed during this study are included in this published article and are available from the corresponding author on reasonable request.
Authors ‘contributions
Germán Garabano and Cesar Pesciallo contributed to the study conception and design. Material preparation, data collection and analysis were performed by Germán Garabano. The first draft of the manuscript was written by German Garabano and Cesar Pesciallo commented on previous versions of the manuscript. Both authors read and approved the final manuscript.
Declaration of competing interest
None.
Acknowledgments
none.
References
Metsemakers W.J.
Fragomen A.T.
Moriaty T.F.
et al.
Fracture-Related Infection (FRI) consensus group. Evidence-based recommendations for local antimicrobial strategies and dead space management in fracture-related infection.
Masquelet technique in post-traumatic infected femoral and tibial segmental bone defects. Union and reoperation rates with high proportions (up to 64%) of allograft in the second stage.
Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee.
Treatment of infected non-unions of the femur and tibia in a French referral center for complex bone and joint infections: outcomes of 55 patients after 2 to 11 years.
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