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abstractFull article available online at Healio.com/Orthopedics. Search: 20121120-23

Open tibial shaft fractures are the most common open fractures, and many complica-tions can occur. During the treatment period, infection leading to osteomyelitis was the most common complication. However, no consensus exists regarding the ideal management for such cases in the literature.

The purposes of this retrospective study were to review the treatment of patients with chronic tibial shaft osteomyelitis over the past 14 years who were referred to the authors’ institution and to provide a staged protocol for spontaneous wound healing. The staged protocol included: (1) radical debridement for infected bone and soft tissue; (2) immediate application of Ilizarov’s apparatus for all patients except those needing delayed applica-tion; (3) osteotomy in healthy bone; (4) simultaneous distraction–compression osteogen-esis and histogenesis; (5) additional docking-site bone grafting; and (6) shifting the external fixator to a locked nail when callus formation was visible at the distraction site. Union was achieved in 15 of 16 patients, with an average external fixation time of 4.5 months (range, 3-6 months). No deformity or leg-length discrepancy greater than 1 cm occurred.

In the treatment of chronic osteomyelitis, this staged protocol was safe and successful and allowed for union, realignment, reorientation, and leg-length restoration. Regarding the soft tissues, this technique provides a unique type of reconstructive closure for infected wounds. It is suggested that the staged protocol is reliable in providing successful simulta-neous reconstruction for bone and soft tissue defects without flap coverage.

Dr Lin is from the Department of Surgery, Taipei Veterans General Hospital Su-Ao Branch, Su-Ao Town, Yi-Lan County, Drs Chen (Chuan-Mu), Chiu, Su, Liu, and Chen (Tain-Hsiung) are from the Department of Orthopedics and Traumatology, Taipei Veterans General Hospital and also the Department of Surgery, National Yang Ming University, and Dr Chen (Chuan-Mu) is also from the Department of Orthopedics, Cheng Hsin General Hospital, Beitou District, Taipei City, Taipei, Taiwan, R.O.C.

Drs Lin, Chen (Chuan-Mu), Chiu, Su, Liu, and Chen (Tain-Hsiung) have no relevant financial rela-tionships to disclose.

Correspondence should be addressed to: Chuan-Mu Chen, MD, Department of Orthopedics, Cheng Hsin General Hospital, No. 45 Cheng Hsin St, Beitou District, Taipei City 112, Taiwan, R.O.C. (chen_chuan_mu@hotmail.com).

doi: 10.3928/01477447-20121120-23

Staged Protocol for the Treatment of Chronic Tibial Shaft Osteomyelitis WithIlizarov’s Technique Followed by the Application of Intramedullary Locked NailChun-Cheng Lin, MD; Chuan-Mu Chen, MD; Fang-Yao Chiu, MD; Yu-Pin Su, MD; Chien-Lin Liu, MD; Tain-hSiung Chen, MD

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Figure: Photograph showing the Ilizarov’s appara-tus with bifocal approach and the extended fixator for forefoot anchorage.

ORTHOPEDICS | Healio.com/Orthopedics

n Feature Article

Tibial diaphyseal fractures are the most common open fractures. More than 50% of open fractures

in the authors’ institution are classified as high-energy Gustilo-Anderson type III fractures. Many complications can occur, including nonunion, malunion, delayed union, bone and joint deformities, chronic edema, compartment syndrome, limb-length discrepancy, infection, and ampu-tation.1-5

In the experience of the surgeons of the Taipei Veterans General Hospital, it is difficult to treat the comminuted frac-tures in Gustilo-Anderson type III frac-tures with only standard intramedullary nailing or internal fixation, particularly in the setting of large bone and soft tis-sue defects. Although autogenous bone grafting may be used to fill bone defects, donor-site morbidity and insufficiency ex-ist in large segmental defects, in which case the autogenous bone grafting could be performed only as a secondary pro-cedure. Furthermore, the management of these fractures is complicated by con-comitant neurovascular and soft tissue injuries, which cause the risks of limb infection and amputation. In the event of complete bony union, these treatment dif-ficulties may lead to the functional decline of limbs with limb-length discrepancy, de-formities, and joint contracture.

Soft tissue damage around the fractures and subsequent wound management are of-ten the main factors affecting the outcomes of open tibial fractures. During tibial bone fixation, early application of either a local muscle flap or a free flap may be the appro-priate treatment, respectively, for the defect around the proximal two-thirds or the dis-tal one-third of the tibia. However, the local flap can be suboptimal because the rotated muscle often falls in the severe injury zone. However, the application of a free flap re-quires microsurgery and local blood sup-ply, which may have been compromised by vascular injuries.

Over the past 3 decades, external fixa-tion has become a prominent method for

achieving union in comminuted frac-tures, correcting angular deformity, and reconstructing bony defects using distraction osteo-genesis.6-8 This sur-gery is performed percutaneously to minimize soft tissue trauma. Advanced techniques using the Ilizarov method can provide healing capacity for large bone and soft tissue defects without the need for flap cover-age and provide an alternative to ampu-tation.9 Distraction histogenesis has also been used for skin expansion around the contrac-ture joint.10

In the current study, infection lead-ing to osteomyelitis was considered the most common com-plication. However, no consensus exists regarding the ideal management of os-teomyelitis after treating open tibial shaft fractures in the lit-erature. The purposes of the current retro-spective study were to review the treatment of patients with chronic tibial shaft osteo-myelitis over the past 14 years who were referred to the authors’ institution (Taipei Veterans General Hospital) and to provide a staged protocol for spontaneous wound healing using wet-to-dry dressing followed by simultaneous distraction–compression osteogenesis or histogenesis of Ilizarov’s technique to restore the soft tissue defects and the bony gap without further flap cov-

erage and autogenous cancellous bone grafting for the docking site. The external fixator was shifted early to an intramedul-lary locked nail when callus formation was visible at the distraction site.

Materials and Methods Demographic Data

Between October 1997 and March 2012, sixteen patients with chronic os-teomyelitis and soft tissue loss around the tibial shaft underwent this protocol at the authors’ institution. Prior to staged manage-

Figure 1: After previous treatment of plating for open tibial fracture, the patient presented with infection and fracture nonunion. The staged pro-tocol was then applied. Lateral radiograph showing initial status after removal of previous plate (A). Anteroposterior radiograph showing post-operative status after sequestrectomy, applying Ilizarov’s apparatus, and osteotomy in healthy bone (B). Photograph showing the Ilizarov’s ap-paratus with a bifocal approach and the extended fixator for forefoot anchorage (C). Photograph showing the open wound after radical de-bridement and then complete wound healing after simultaneous distraction– compression osteogenesis and histogenesis (E). Anteroposterior radio-graph showing visible callus formation at the distraction site, and status post Harmon’s procedure with posterolateral grafting at the docking site (F). Anteroposterior (G) and lateral (H) radiographs showing bony union at 1-year follow-up.

1A 1B 1C 1D

1E 1F 1G 1H

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ment, each patient had a complete examina-tion, including electromyography, angiogra-phy, and triple-film radiographs of the lower limbs. Inclusion criteria were: an absence of pin-tract infection when shifting the external fixator to a locked nail and a suitable space in the intramedullary canal to accommodate a locked nail. Fourteen men with a mean age of 36 years (range, 18-70 years) were select-ed. Ilizarov’s apparatus (Smith & Nephew Richards, Memphis, Tennessee) was used after the removal of previous implants, the performance radical debridement, or both. Full weight bearing was allowed to enhance callus maturation during the distraction stage. The average length of the bone and

soft tissue defects after radical debridement was 8 cm (range, 4-12 cm). The latency period was 7 days, followed by simultane-ous distraction–compression osteogenesis and histogenesis after osteotomy in healthy bone. A bone defect longer than 6 cm was an indicator of trifocal transport. Temporary extended fixator for anchorage of the fore-foot was used in each case to avoid the relative complication of equinus deformity. Additional bone grafting was performed around the docking site in all patients.

StrategiesThe staged protocol (Figures 1A-H,

2A-L) for treating chronic osteomyeli-

tis and soft tissue loss around the tibial shaft included: (1) radical debridement for infected bone and soft tissue and the additional insertion of an antibiotic- impregnated cement-rod for 10 days in cases of previously existing septic med-ullary implant; (2) the immediate ap-plication of Ilizarov’s apparatus for all patients except those needing delayed application because of previously exist-ing septic medullary implant; (3) oste-otomy in healthy bone; (4) simultaneous distraction–compression osteogenesis and histogenesis; (5) additional docking-site bone grafting; and (6) shifting the external fixator to a locked nail with a closed tech-nique when callus formation was visible at the distraction site. Vancomycin was used throughout treatment for all patients.

Radical Debridement. Performing radical debridement before the Ilizarov’s procedure is necessary. With regard to infected bone, adequate debridement should supply a healthy appearance of the remaining bone with an opened intramed-ullary canal and bleeding surface, which is best performed under the use of tourni-quet. During sequestrectomy, the typical bone cut is made perpendicular to the ana-tomic tibial axis using a power saw cooled with saline irrigation. Under C-arm fluo-roscopy, a K-wire is used as a guide for the bone cut. The remaining bone edges require soft tissue coverage to avoid desic-cation, secondary necrosis, and osteomy-elitis. When determining the amount of diseased bone removed, the bone quality priority, rather than bone volume, was ad-opted. The remaining bone surfaces had visible bleeding spots and serosanguinous fluid discharged from the opened intra-medullary canal or the multiple pin tracts made on the cancellous bone. The surgi-cal wound was left open, and wet dress-ing was necessary. Then, the presence of granulation tissue around the proximal or distal bone surface ensured the previously adequate debridement. However, the soft tissue defect was ideally fashioned into a basin-like shape, which provided histo-

Figure 2: The patient sustained an open segmental tibial shaft fracture with infection and had been treated with intramedullary locked nail at another institution approximately 3 months before presentation. The staged protocol of the clinic was applied. Anteroposterior (A) and lateral (B) radiographs and photograph (C) showing the condition on arriving. Anteroposterior radiograph showing postoperative status after radical debridement, removal of locked nails, sequestrectomy, and residual 12 cm of bone defect (D). Anteroposterior (E) and lateral (F) radiographs showing that bone transport was performed with a trifocal-approach. Anteroposterior (left) and lateral (right) radiographs showing visible callus (G). Photograph taken on arrival at the docking site showing Ilizarov’s apparatus with an extended fixator for forefoot anchorage (H). Anteroposterior (I) and lateral (J) radiographs obtained after removing the external skeletal fixator showing intramedullary locked nail and bone consolidation after Harmon’s procedure. Anteropos-terior (K) and lateral (L) radiographs showing bony union at 1-year follow-up.

2A 2B 2C 2D 2E 2F

2G 2H 2I 2J 2K 2L

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n Feature Article

genesis a platform to approximate wound edges. the Ilizarov’s apparatus was ap-plied immediately following radical de-bridement.

Ilizarov’s Apparatus. To set up the Ilizarov’s apparatus, the surgeons placed two 4-mm full pins with central threads (Smith & Nephew Richards), which were parallel to the joint line under the guid-ance of fluoroscopy, through the proxi-mal and distal tibia for stronger connec-tions with up- and nethermost rings, re-spectively. All rings of the Ilizarov’s ap-paratus should be arranged concentrical-ly. Most of the connections were 1.8-mm smooth or olive wires through the tibia, perpendicular to the tibial axis, and with 2 ends fixed on the ring. For each ring block, 1 wire was applied as a reference on the coronal tibial plane. Then, another wire was accordingly applied next to the first wire, forming a transverse ring plane. The clearance between the soft tissue and the rings was approximately 2 fingerbreadths. A tension of 110 kg was suggested for fixing smooth wires, whereas 90 kg was suggested for olive wires. An additional 5-mm half-pin was selectively applied in the adaptive site to enable the ring more stability on the plane perpendicular to the tibial axis. Therefore, setting each ring block should have a combination of 2 wires with or without 1 half-pin. All wires and pins were placed through the safe zone to avoid neurovascular structure injury.

Osteotomy. The subsequent oste-otomy in healthy bone was suggested 1 week after applying the external fixator. When a short bone segment is left after an osteotomy in the proximal or distal tibia, extending the circle frame across the knee or ankle joint should be con-sidered, at least temporarily. In the ex-perience of the surgeons of the Taipei Veterans General Hospital, the strategy is most commonly used for the distal tibia. Using the intraoperative olive-wire reduction technique, the bone defect edges should be perfectly pointed toward

each other to avoid deviation during bone transport and to optimize contact at the anticipated docking site.

Simultaneous Distraction–compression Osteogenesis and Histogenesis. With the adjustable rods longitudinally applied be-tween the rings, simultaneous distraction– compression osteogenesis and histogenesis were administrated 7 days after osteotomy. Osteogenesis was periodically monitored during the first postoperative month and af-ter full weight bearing. During the Ilizarov procedure, monofocal, bifocal, and trifocal approaches were the 3 novel approaches chosen for bone and soft tissue transport. In the monofocal approach, the 2 bony seg-ments next to the defect were transported toward each other, which caused limb shortening. An osteotomy was performed outside of the healthy bone injury zone using a bifocal approach (Figure 1B). The intercalary segment was then transported and compressed the defect site (Figures 1C-E). A simultaneous lengthening oc-curred through the corticotomy site, which maintained the limb length. A trifocal ap-proach (tandem procedure), which was indicated when a bone loss of more than 6 cm occurred (Figure 2D), used 2 length-ening osteotomies and compression of the defect (Figure 2E). The Ilizarov method of intercalary bone transport was used to treat tibial bone loss and achieve limb salvage.

Bone Grafting. After the periodic as-sessment of regenerated bones, bone mar-row injection was indicated in patients with slow maturation of regenerative bone at the 2-month follow-up. Additional bone graft-ing also improved docking site healing af-ter wound closure and eradicated infection in all patients. Using Harmon’s11 procedure with posterolateral grafting at the middle and distal tibia was recommended.

Intramedullary Locking Nail Application. When callus formation was visible at the distraction site, it was con-sidered the appropriate time to apply the intramedullary locking nail (Smith & Nephew Richards). However, when cal-lus formation was visible at the distrac-

tion site, regenerative solid bone existed on the pathway leading to higher tech-nique demand for intramedullary nailing. Under an external fixator for keeping the anatomical reduction, a long, rigid guide-pin (Rush Pin LLC, Meridian, Mississippi) with sharp ends was used to make a tract break through the regenera-tive callus. Then, the locking nail (Smith & Nephew Richards) was introduced across the docking site after adequate reaming. A locked intramedullary nail was applied after adequate reaming.

Wound Management PrinciplesNecrotic and devitalized tissues should

be debrided while preventing exposure of the remaining healthy bone. The wounds should be left accessible, with the leg in the circle frame. Several self-incremental adjustments were made on each day. Patient involvement and cooperation were important while using this method. The self-care of wounds was also essen-tial during the transporting phase until closure occurred. In most patients, the wounds were managed with daily nor-mal saline wet-to-dry dressing during the transporting phase until closure oc-curred. In addition to normal saline, di-luted H2O2 (about 1:1) in wet gauze as a disinfectant for treating wounds 3 days postoperatively (radical debridement) was used and kept for 2 more weeks. More re-cently, a vacuum-assisted closure (VAC)device was used on open wounds during the transporting phase. As the transport progressed, the granulation tissue was ex-pected to appear, and the wound size grad-ually decreased until the wound healed.

resultsUnion was achieved in 15 of 16 pa-

tients, with an average time to external fix-ation of 4.5 months (range, 3-6 months). No deformity or leg-length discrepancy greater than 1 cm occurred. Bone marrow injection to the regenerate site was 15%. One patient had a recurring infection but refused further treatment.

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discussionAn innovative alternative to compen-

sate for bone loss is to transport healthy bone to the fracture site to bridge the bone defect.12 The dynamic frame enables grad-ual lengthening, deformity correction, and compression of nonunion or delayed union with minimal invasion. The soft tis-sue envelope regenerates around the bone transport. The bone transport technique was initially reported as distraction os-teogenesis by Ilizarov,13 and then became widely used by orthopedic surgeons in the West.6-8 However, this method also has disadvantages, including a prolonged ex-ternal fixation period.14

Regarding soft tissue loss, the early application of muscle-flap coverage was often considered a procedure that pro-vided an infection barrier and promoted healing.15,16 Many have also reported that using appropriate soft tissue coverage is necessary for preventing infection and bone desiccation.17-19 Regardless, some problems remain in the extensive soft tissue injuries and vascular disruption in severe tibial fractures.20 Thus, opinions for flap coverage may be limited. On oc-casion, plastic surgeons state that patients are not candidates for flap reconstruction due to local soft tissue unavailability, po-tentially poor vascular supply (eg, single vessel, preexistent procedure of revascu-larization, or plaque disease of vessels), and systemic comorbidities that make patients intolerant to time-consuming sur-gery. In addition, another flap coverage revision is almost infeasible after previ-ous flap necrosis. With a lack of adequate wound coverage, many patients may face inevitable osteomyelitis and amputation.

Overall, many methods exist for the obliteration of the dead space after radi-cal debridement for necrotic bone and soft tissue, including exteriorization, plom-bage, cancellous bone grafting or bone substitutes, transfer of living tissue, and the simultaneous treatment of bone and soft tissue with Ilizarov’s method.21,22 The Ilizarov method, which can be used suc-

cessfully to reconstruct legs with tibial bone loss and soft tissue defects simul-taneously, was chosen for the current pa-tients. This limb-salvage method can be used in patients who are not candidates for flap coverage. Another concern regarding the use of this technique was to prevent patients from possible failure of flap cov-erage. Gradual defect closure was accom-plished, resulting in bone and soft tissue healing. Limb lengthening can be per-formed outside the injury zone in healthy bone and soft tissue. A trifocal approach should be considered for defects larger than 6 cm. Technique and frame design advances should help prevent residual de-formity.

The priority of reconstructive meth-ods for soft tissue defects is controversial and may create a dilemma for surgeons in determining whether soft tissue trans-port should be used as the last resort only when flap coverage is not available or if it should be used as the priority to avoid possible flap coverage failure. Previous reports showed that simultaneous bone and soft tissue transport could success-fully avoid the need for flap coverage.9 The final choice depends on the surgeon’s preference and the availability of plastic surgeons. The treatment time is long, and patients report pain, especially during the transporting phase. Potential complications include limb-length discrepancy, malalign-ment and malorientation, joint contracture, pin-tract problems, nonunion, refracture, recurrent infection, and limb loss.13,23,24

Although potential complications ex-isted in previous studies, no irreversible complication occurred from the proce-dure during distraction–compression os-teogenesis and histogenesis in the current study. Minor complications were resolved with conservative treatments, whereas major complications required additional surgery. Mild pin-tract infections were treated by local care and oral antibiot-ics. For severe pin-tract infections, sur-gical debridement was performed with exchanging wire/screw and intravenous

antibiotic therapy. Distraction-area pain was the most common report during the transporting phase. In the patients who needed lengthening of more than 4 cm, dermal irritation from wires and screws that increased pain happened more fre-quently. Otherwise, the increased pain would be relieved by oral analgesics.

Staged management for chronic tib-ial shaft osteomyelitis is a top standard. Staged management for infected tibial shaft nonunion followed by locked intra-medullary nailing had been reported by Klemm20 via 3 or 4 stages.In this research, the principles of staged management were followed, and the intramedullary locked nail provided stable fixation via a closed technique. Insertion of the interlocking nail at the same time as the external fixa-tion was supposed to be avoided in previ-ous studies because of concerns of poten-tial infection.25,26 However, early removal of the external fixator and replacement by intramedullary nail achieved the same clinical and functional outcome as the classic technique with a shorter duration of external fixation.27-29 Furthermore, the suggested adequate time to perform nail-ing was when callus formation was radio-graphically visible at the distraction site because the intramedullary implant could occupy the healing space for osteogenesis.

conclusionIn the treatment of chronic osteomyeli-

tis, the staged protocol proposed by the au-thors is safe and successful. The same tech-niques that were used for all cases allow for union, realignment, reorientation, and leg-length restoration. Regarding the soft tis-sues, this protocol provides a unique type of reconstructive closure for infected wounds. The cases of tibial open fractures with complicated osteomyelitis and soft tissue loss in the past 14 years were retro-spectively reviewed, and it is suggested that the staged protocol is reliable in pro-viding successful reconstruction simulta-neously for bone and soft tissue defects without flap coverage.

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