Extreme complications of Fixion nail in treatment of long bone fractures

The authors present their experience related to extreme complications in treatment of diaphyseal fractures of the long bones with application of the Fixion expansion intramedullary nail in a total of 48 surgeries. We have encountered six (12.5%) extreme complications in the management of fractures of 3 humeral, 2 tibial, and 1 femoral bones during its application procedure and postoperative follow-up. Of six cases, two with humeral and tibial fractures developed nonunion and rotational instability because of failure of inflation of the Fixion nail. One of the Fixion nail in humerus was broken spontaneously, and one of the Fixion nail deflated at the follow-up and pseudoarthrosis developed in this patient. In a patient with osteogenesis imperfecta, during the inflation of the nail for the treatment of femur fracture, a new longitudinal fracture occurred and conventional non-locking intramedullary nail was inserted. In a patient with a tibia fracture that was treated with the Fixion nail, new fracture occurred due to its bending after weight bearing in the postoperative period. The Fixion nail application is a new technique for the intramedullar fixation of long bones. It is considered as an effective method for the selective fracture types of long bones. Application may need special training. Since the Fixion has not got rotational stability and rigidity as conventional nailing systems, bending and breaking of the nail may occur during postoperative period in patients with over obesity and hyperactivity. In patients with osteogenesis imperfecta, it may not be the first choice as a nailing system.     

The Fixion nail in the lower limb. Preliminary results

The Fixion nail is an intramedullary nail made of stainless steel, that may be used to treat fractures of the humerus and in the lower limb. This nail is made up of a cylinder that has 4 longitudinal bars which, once inserted in the bone segment, expands via a pressure hydraulic system using physiological solution. The nail may be introduced without reaming and after its expansion it adheres to the bone walls producing stabilization of the fracture. In order to guarantee good stability, the apex of the nail must exceed the fracture line by 5 cm. Indications were initially limited to type 32 and 42 A1-2-3 fractures of the mid third of the lower limb, to then be expanded to type B1 fractures in the AO system. A total of 20 nails were used in 19 patients, with an average time of 7 days for partial weight-bearing and 40 days for total weight-bearing, achieving consolidation on day 18 after an average of 5 months in the femur and 4 months in the tibia. Reaming of the intramedullary canal was carried out in all of the cases.     

Clinical and radiological midterm results from using the Fixion expandable intramedullary nail in transverse and short oblique fractures of femur and tibia

Background  A locked nail is the principal method used to eliminate rotatory components in femoral and tibial fractures. Nevertheless, weight bearing is not directed onto the fracture site, slowing down the healing process; another possibility is to use a large-diameter nail and ream the canal to obtain as much adherence as possible and increase the grip, but this can cause a number of complications. The expandable nail is a new option that in theory should remove some problems with previous techniques. Materials and methods  This was a retrospective nonrandomized study encompassing 21 femoral fractures and 27 tibial fractures in 45 patients. They were classified according to the AO classification. Clinical and radiological checks were done at one, three, and six months and at one year from the surgery in order to check for signs of clinical and radiological healing. A good alignment was considered to be the presence of a deformity of less than 5° in the sagittal and lateral planes and the absence of rotatory clinically evident problems. This protocol was adhered to up to six months after surgery by all of the patients, while only 62.2% performed the last control. The mean follow-up was 15 months. A second group of 48 consecutive fractures (24 femural and 24 tibial) treated with locked nail was created to compare surgical times. Results  Appropriate alignment was observed in all cases; the healing process appeared slower: radiological healing occurred in most cases at six months. The following complications were reported: a case of intraoperative fracture widening with no effect on the treatment; a case of a lesion of the tip of the nail with pneumatic system rupture that necessitated nail substitution; two cases of retarded consolidation at six months, with both tibial fractures treated successfully by intralesion platelet gel; a case of incarcerated nail on 17 removals, resolved by shearing. We had no cases of clinically evident compartment syndrome or pulmonary embolism. Conclusions  The expandable Fixion nail presents significant advantages in the treatment of transverse and short oblique fractures of femur and tibia because it is easy to use, involves minimal X-ray exposure and can control rotations. Nevertheless, it high cost limits its use. We consider it as an alternative to locked nail.     

Fixion膨胀髓内钉在四肢长骨骨折中的应用

目的探讨Fixion膨胀髓内钉在长骨骨折中的应用价值与技术特点。方法应用Fixion膨胀髓内钉系统进行手术内固定25例。结果25例均获随访,时间5～18个月。患者全部达到骨折愈合,时间5～14个月。无畸形愈合发生,髓内钉无断裂、折弯、松动或膨胀丢失,无脂肪栓塞、感染等并发症,功能恢复好。参照Johner—Wruhs功能评定标准：优12例,良9例,可4例。结论Fixion膨胀髓内钉具有良好的髓腔适配,操作方法简便,切口小,创伤少,手术时间短,术后恢复快,适合治疗四肢长骨骨折。     

An expandable nailing system for the management of pathological humerus fractures

BACKGROUND: People with metastatic fracture of the humerus are of poor general health. Often they are not able to compensate the handicap of an impaired extremity. Standard osteosynthetic techniques are not always applicable. To reduce the trauma of the operation, we used the Fixion expandable nail system. METHODS: At two centers, 23 metastatic fractures of the humerus (in 22 patients) were stabilized with a new nailing system. The nail expands under hydraulic pressure up to 150% of its uninflated diameter, gaining long frictional contact to the bone. All patients were followed up until osseous healing occurred or until they died. RESULTS AND CONCLUSIONS: The operative time was approximately 32 min, including 1.4 min fluoroscopy time. Nail insertion is brief and therefore not very stressful to the group of debilitated patients who require this intervention. Immediately postoperatively, the upper extremity is stable to permit physiotherapy. In these few patients, we saw no complications. The advantages of the surgical approach appear to outweigh those of conservative management options if a simple and safe surgical technique makes the humerus stable enough to resist normal daily loads.     

Bending and torsional stiffness in cadaver humeri fixed with a self-locking expandable or interlocking nail system: a mechanical study

OBJECTIVES: This study was designed to gain data about a new expandable, noninterlocked intramedullary nail's capacity to stabilize unstable transverse humeral shaft fractures without the need for interlocking, thus making nail implantation simpler and to prove our goal hypothesis: that in a midshaft osteotomy of the humeral shaft the expandable humeral nail will show the same bending and torsional stiffness as an interlocked humeral nail, when implanted correctly according to the manufacturer's instructions. DESIGN: Pair randomization. SETTING: Mechanical laboratory testing. PARTICIPANTS: Eight pairs of freshly harvested cadaveric humeri. INTERVENTIONS: Fracture model was a midshaft transverse osteotomy, gapped to 3 mm. Each humerus pair received an expandable humeral nail (Fixion) or an interlocked humerus nail (Synthes) through a retrograde approach. The humeri were fixed in polymethylmethacrylate cylinders and tested in a servo-pneumatic material-testing machine. MAIN OUTCOME MEASUREMENTS: Torsional stiffness and bending stiffness of the nail-bone-construction. RESULTS: Expandable nails (interlocked nails) showed a lateral bending stiffness of 0.73 +/- 0.14 (0.63 +/- 0.1) KN/mm (P = 0.026) and a frontal bending stiffness of 0.67 +/- 0.18 (0.58 +/- 0.09) KN/mm (P = 0.084). Torsional stiffness values were 0.13 +/- 0.19 (0.43 +/- 0.09 Nm/degrees) (P = 0.012). Lower torsional stiffness in the expandable nail group was observed in humeri with a funnel shaped proximal intramedullary canal. CONCLUSIONS: The nail systems showed similar characteristics for frontal bending (P = 0.084), but not for lateral bending (P = 0.026). For lateral bending, the Fixion nail showed significantly more stiffness than the UHN nail (P = 0.026). There was significantly lower torsional stiffness with expandable nails compared with interlocked nails. Clinical correlation would suggest that in rotationally unstable fractures (A2 and A3 diaphyseal fractures), interlocked nails would provide increased stability over expandable nails.     

Treatment of proximal humeral fractures with a new intramedullary nail

We have developed a new intramedullary nail (All-in-One Nail) that is specifically designed for elastic fixation of a surgical neck fracture of the humerus. This nail has three pins and a plate, and the pins become divergent as the nail is inserted into the marrow cavity through the deltoid tuberosity and then advanced to the humeral head. We reviewed 31 patients with an age range of 58–91 years (mean 75 years) who underwent surgery with this nail for A3.2 (two-part), B2.2 (three-part), or C2.1 (valgus-impacted) fractures of the proximal humerus. Bony union was obtained in 29 patients, and these patients had a Japanese Orthopaedic Association shoulder score of 60–92 (mean 78) in a follow-up examination performed 6–32 months (mean 13 months) postoperatively. The All-in-One Nail system is easy to use, provides an acceptable clinical outcome, and is a treatment option for unimpacted surgical neck fractures and valgus-impacted fractures of the humerus.     

New intramedullary nail for the surgical neck fracture of the proximal humerus in elderly patients

Background Fractures of the proximal humerus are common and the repair of displaced fractures generally requires an operative approach. In elderly patients, osteoporosis makes internal fixation problematic and frequently contributes to failed fixation and poor clinical results. We have developed a new intramedullary nail (pin lock nail) for the repair of surgical neck fractures of the proximal humerus in patients with osteoporotic bones. A retrospective review is presented of the cases of 19 elderly patients with two-part or three-part fractures of the proximal humerus treated using the pin lock nail. Methods We treated 19 elderly patients with a mean age of 70.5 years. There were 13 two-part surgical neck fractures, 3 two-part surgical neck fractures with non-displaced greater tuberosity fracture, and 3 three-part surgical neck fractures with greater tuberosity fracture. All fractures were treated using the pin lock nail. Clinical results were evaluated using the Japanese Orthopaedic Association score at the last follow-up examination. On radiographic evaluation, duration to bone union of the fracture, backing out of the pin and screw, penetration of the proximal pin, and varus angulations of the humeral neck were examined. Results Mean duration of follow-up was 14 months (range 6–54 months). All fractures had united at an average of 3.3 months after surgery. No backing out of the pin and screw or penetration of the proximal locking pin was seen at the time of last follow-up. Thirteen of the 16 patients had no or minimal varus angulations of the humeral neck (≤10°). The mean overall JOA score was 84.3 points (range 65.5–100). Conclusions Our data show that using the pin lock nail for the treatment of two-part and three-part humeral fractures is a reliable procedure, providing good results with careful postoperative management.     

可膨胀髓内钉Fixion系统治疗四肢骨折

目的：可膨胀髓内钉Fixion^TM系统是髓内钉固定理念和技术的革新,本文探讨这一新技术在治疗四肢骨折中的方法和临床效果,以及临床应用过程中的一些体会。方法：自2004年8月至2005年1月,21例骨折病人采用Fixion^TM系统治疗。男16例,女5例,年龄21～75岁。1例为开放伤,3例为骨折不愈合,1例病理性骨折。应用部位为胫骨干5例;股骨干7例;肱骨干4例;股骨近端5例。结果：本组21例伤口全部一期愈合,手术时间35～210min,平均90min。术中出血30～1500ml,平均出血量280ml,术中平均透视4．9次。X线片示股骨干、胫骨干骨折术后4周均有骨痂出现,骨折术后临床和影像学愈合时间为：胫骨干骨折12周,股骨干骨折10周,肱骨骨折12周,股骨近端骨折10周。无感染、脂肪栓塞、深静脉血栓、骨折不愈合、肢体短缩及旋转畸形发生。结论：可膨胀髓内钉根据髓腔解剖特点呈沙漏样固定,应力分布更为均匀;节省了扩髓和锁钉的操作,减少了创伤、手术时间、医生和病人接受的X线剂量和感染率;轴相弹性固定加快了骨折愈合时间。在掌握好适应证和正确操作的前提下,Fixion^TM系统治疗四肢骨干骨折和股骨近端骨折有比传统交锁髓内钉更好的效果,尤其适用于骨质疏松病人的治疗。     

The Fixion nailing system for stabilising diaphyseal fractures of the humerus: a two-year clinical experience

Previous studies have shown that the expandable nail system (Fixion) can provide rapid stabilisation of long bone fractures with reduced operative time and low complication rates. Patients with humeral shaft fracture were treated consecutively over a two-year period in our institution with the Fixion nail. Nineteen Fixion nailings were performed in 16 patients over a 2 year period. All fractures were diaphyseal and closed. Eight primary fracture stabilisations were performed and we recorded 2 nonunions in this group, both associated with rotational instability at the fracture site. Six nailings were performed in 4 patients for fracture non-union with a mean operative time of 127.5 minutes. One case did not unite despite 3 separate Fixion nailing procedures. Five operations were performed for a pathological fracture, with a mean operative time of 79 minutes; they all united. We did not experience advantages of this nail as mentioned in previous studies and the complication rate was higher than previously stated.     

弹性髓内钉治疗儿童长干骨骨折中并发症的分析

目的：探讨弹性髓内钉治疗儿童长骨骨折并发症的原因。方法：应用弹性髓内钉治疗儿童长骨骨折66例（75个部位）,男49例,女17例;年龄3-17岁,平均7．8岁。其中股骨35例（2例双侧）,胫腓骨骨折20例（12例为胫骨骨折）,尺桡骨8例（单纯尺骨1例）,肱骨3例。开放骨折4倒,闭合骨折62例,均为新鲜骨折,无多段骨折。合并脑、胸等复合伤3例。均采用闭合复位或切开复位、弹性髓内钉固定,术后石膏托或支具有限固定1个月。术后定期复查X线片。复查内容包括：关节功能,针尾情况,X线片骨痂生长情况,记录并发症及处理。结果：全部病例均获随访,随访时间12～29个月,平均19个月。并发症：骨不愈2例,进针点或骨折端骨折劈裂2例,骨折端移位1例,关节活动受限4例,针尾激惹3倒,骨折畸形愈合1例。结论：严格把握手术指征、精心的术前设计、规范的操作是避免手术并发症的有效手段。     

Treatment of acute tibial shaft fractures with an expandable nailing system: a systematic review of the literature

Locked Intramedullary Nailing is an established method of treatment for tibial shaft fractures. Locking of tibial nails is however not without its drawbacks. Locking is time consuming, and is associated with a noteworthy complication rate. The Fixion IM nailing system is an expandable nail designed to eliminate some of these drawbacks. We have performed a systematic review of the literature to determine the safety and efficacy of this system. Publications examining the use of the Fixion system were identified from the MEDLINE and the Cochrane databases. Forty-one citations were generated by the MEDLINE search. Of these, two quasi-randomised trials and eight case series satisfied our selection criteria and were reviewed. Overall the average reoperation rate for the Fixion nail was 10.2%. Shortening occurred in 3% of cases and fracture propagation was reported in 2% of cases. The Fixion cohort united at an average of 12.2 weeks and the average operative time was 54 minutes. The Fixion system eliminated complications and reoperations associated with the use of locking screws. Further studies in the form of randomised controlled trials are needed to evaluate the Fixion system against conventional locked nails.     

Expandable nail system for osteoporotic humeral shaft fractures: preliminary results

BACKGROUND: Conventional nails rely on interlocking screws for axial and rotational stability. Such screws have poor fixation in patients with poor bone quality (osteopenia). The Fixion nail does not depend on interlocking screws-axial and rotational stability is instead achieved by nail expansion. Therefore, this nail may be better suited for patients with poor bone quality who require humeral stabilization. METHODS: The system was used to manage 25 unstable humerus shaft fractures in osteoporotic bone. An antegrade approach was used in 18 patients and a retrograde approach was used in 7 patients. RESULTS: There were no intra- or postoperative complications. Postoperatively, all fractures were stable and had healed by week 16. The mean operative time was 35 +/- 10 minutes (+/- SD) including 1.5 +/- 0.5 minutes of fluoroscopy time. CONCLUSION: The results of this study show that use of this nailing system is associated with minimal complications, predictable fracture healing, and excellent functional outcomes in a cohort of elderly patients with poor bone quality and humeral shaft fractures requiring stabilization. Further confirmation by larger prospective trials is necessary.     

闭合复位交锁髓内钉治疗胫骨干骨折

目的探讨闭合复位交锁髓内钉治疗胫骨干骨折的临床应用和疗效。方法对21例胫骨干新鲜闭合性骨折患者行闭合复位交锁髓内钉静力性固定。结果经6~29个月随访,21例骨折全部愈合。结论闭合复位交锁髓内钉是治疗胫骨干骨折的理想方法。     

The treatment of established non-union of the proximal humerus using the Polarus locking intramedullary nail

Introduction:

Non-union following fracture of the proximal humerus is not uncommon, particularly in the elderly. This can be associated with significant morbidity due to pain, instability and functional impairment. The Polarus device (Acumed) is a locked, antegrade intramedullary nail designed to stabilize displaced 2-, 3- and 4-part fractures of the proximal humerus. We report our experience with the Polarus nail for the treatment of established non-union of the proximal humerus.

Materials and Methods:

A total of 7 Polarus nails were inserted for the treatment of non-union of the proximal humerus between June 2000 and July 2007. Each fracture site was opened, debrided, stabilized with a Polarus nail and then grafted with autologous cancellous iliac crest bone. The time between injury and surgery ranged from 6 to 102 months. One patient had undergone previous fixation of her fracture using Rush intramedullary rods. All patients were females, and mean age at surgery was 63.6 years (range, 49-78 years). A retrospective review of notes and radiographs was carried out. Patients were reviewed at varying intervals postoperatively (range, 13-68 months) and assessed using the Constant shoulder-scoring system.

Results:

All un-united fractures progressed to union. There were no wound complications and no postoperative nerve palsies. Functional outcome was good, even in those cases with a long interval between injury and surgery. The mean Constant score was 63 (range, 54-81). Migration of a single proximal locking screw was seen in 2 patients, and these screws required removal at 5 and 12 months, respectively, postoperatively.

Conclusion:

In our experience, a locked proximal humeral nail used in conjunction with autologous bone grafting is an excellent device for the treatment of proximal humerus non-unions.     

鞘剑式锁尾弹性髓内钉的研制和临床应用

目的探讨鞘剑式锁尾弹性髓内钉闭合穿钉治疗胫腓骨和肱骨骨折的临床内固定效果.方法鞘剑锁尾弹性髓内钉闭合穿钉内固定治疗胫腓骨和肱骨骨折42例,观察临床固定效果及手术后并发症.结果术后10～12个月随访并取钉,临床效果满意,优28例;良12例;差2例,优良率95.2%,均达骨性愈合,顺利取钉.结论该钉治疗胫腓骨和肱骨骨折具有手术方法简便易行,费用低,属微创范围.因固定牢,准确可靠程度高,手术创伤小,能有效地控制远端旋转移位等优点.     

非扩髓型肱骨内锁髓内钉的研制和临床应用

目的：设计出非扩髓型肱骨内锁髓内钉用于治疗肱骨骨折。方法：作者对国人尸体肱骨及其髓腔石蜡铸型进行了观察和测量，在此基础上设计出非扩髓型肱骨内锁髓内钉，用于临床治疗肱骨骨折１０例。结果：作者对平均术后１年４个月的１０例患者进行了随访，骨折愈合优良率达到９０％（９／１０），肩肘关节动度优良率达到８０％（８／１０）。结论：作者认为非扩髓型肱骨内锁髓内钉的口径和长度适合国人，手术无需扩髓，瞄准器使用方便，它治疗肱骨骨折，尤其是对多发骨折、粉碎性肱骨骨折、骨不连和病理性骨折等的治疗更适合。     

A new locking nail for proximal humerus fractures: the Telegraph nail, technique and preliminary results

We present a new nail, the telegraph nail, designed for the treatment of proximal fractures of the humerus. This nail has a new locking system providing a self-stabilization of the cancelous screws inserted in small fragments. We discuss the surgical technique and present preliminary results. The anterolateral approach and nail insertion through the medial and well vascularized part of the cuff is described for simple fractures. With the cup and ball technique, this nail can also be used for complex fractures of the proximal humerus with three or four fragments and major displacement. With this method, the nail is inserted before reduction and locked in the distal humerus before fixation of the head and tuberosities around the head once the targeting device removed. We report results for the first 64 nails inserted in our unit during the first year (1998-1999). Outcome was assessed at 11 months mean follow-up using the Constant score. Outcome was favorable, including in patients with complex fractures involving 3 or 4 separate displaced fragments. Besides providing an anatomically stable reconstruction, the telegraph nail has the advantage of allowing early mobilization of the shoulder joint. This method is a useful alternative to prosthetic reconstruction for traumatic fractures of the proximal humerus.     

Dynamic osteosynthesis by modified Kuntscher nail for the treatment of tibial diaphyseal fractures

Background:

We evaluated a series of diaphyseal fractures of the tibia using low-cost, Indian-made modified Kuntscher nail (Daga nail) with the provision of distal locking screw for the management of the tibial diaphyseal fractures.

Materials and Methods:

One hundred and fifty one consecutive patients with diaphyseal fractures of tibia with 151 fractures who were treated by Daga nail were enrolled. One of the patients who had died because of cancer, and the two patients who were lost to follow-up at 3 months were excluded from the study.Therefore data of 148 patients with one hundred and fortyeight fractures is described. One hundred twenty closed fractures, 20 open Grade I fractures, and eight open Grade II fractures as per Gustilo and Anderson classification were included in this study. One hundred fourteen men and 34 women, with a mean age of 38.4 years, were studied. The result were analysed for Surgical time, duration of hospitalisation, union time, union rate, complication rate, functional recovery and crutch walking time. The fractures were followed at least until the time of solid union.

Results:

The follow-up period averaged 15 months (range, 6–26 months). Union occurred in 140 cases (94.6%). The mean time to union was 13 weeks for closed fractures,17.8 weeks for Grade I open fractures, and 21.6 weeks for Grade II open fractures. Compartment syndrome occurred in two patients. Superficial infection occurred in five cases of Grade I and II compound fractures. Three closed fractures and one case of Grade I compound fracture required bone grafting for delayed union. Two cases of Grade II compound fracture with nonunion required revision surgery and bone grafting. Twelve cases resulted in acceptable malalignment due to operative technical error. In four cases, the distal screw breakage was seen, but none of these complications interfered with fracture healing. Recovery of joint motion was essentially normal in those patients without knee or ankle injury.

Conclusion:

Unreamed distally locked dynamic tibial nailing (modified Kuntscher nail/Daga nail) can produce excellent clinical results for diaphyseal tibial fractures. It has the advantages of technical simplicity, minimal cost, user-friendly instrumentation, and a short learning curve.     

带锁髓内钉治疗股骨胫骨骨折

目的：探讨带锁髓内钉有股骨,胫骨骨折的应用。方法：选用江苏省武进市生产的带有远近瞄准器的股骨,胫骨钉,治疗不同类型肌骨骨折10例,胫骨骨折8例,结果：随访8月－2年3个月,18例均骨性愈合,未出现骨折,断钉感染及膝,踝关节僵硬等并发症,结论：带锁髓内钉治疗下肢骨折治愈率高,并发症少。