An <Emphasis Type="Italic">in Vivo</Emphasis> Experimental Comparison of Stainless Steel and Titanium Schanz Screws for External Fixation

Abstract Objective: To compare the clinical benefits of stainless steel (SS) to titanium (Ti) on reducing pin track irritation/infection and pin loosening during external fracture fixation. Methods: A tibial gap osteotomy was created in 17 sheep and stabilized with four Schanz screws of either SS or Ti and an external fixation frame. Over the 12 week observation period, pin loosening was assessed by grading the radiolucency around the pins and measuring the extraction torque on pin removal at sacrifice. Irritation/infection was assessed with weekly clinical pin track grading. A histological analysis of the tissue adjacent to the pin site was made to assess biocompatibility. Results: A statistically non-significant trend for less bone resorption around Ti pins was found during the early observation period. However, at sacrifice, there was no difference between the two materials. Also, there was no difference in the extraction torque, and there was similar remodeling and apposition of the bone around the pins. A statistically non-significant trend for more infection about SS pins at sacrifice was found. Histology showed a slightly higher prevalence of reactionary cells in SS samples, but was otherwise not much different than around Ti pins. Conclusions: There is no clinically relevant substantial advantage in using either SS or Ti pins on reducing pin loosening or pin track irritation/infection.     

Skeletal stabilization with a multiplane external fixation device. Biomechanical evaluation and finite element model

The general question of the influence of fracture stability on bone healing remains unanswered and has important bearing on fracture stabilization by external fixation. The stiffness of an external fixator is dependent on pin placement and frame orientation. These parameters are under the surgeon's control, within limits set by soft tissue injury and fixator design. Fixator configuration parameters include common fragment pin separation, common fragment pin angle, common fragment pin number, effective pin length, use of transfixing pins versus half-pins, and use of two versus three connecting rods. Each configuration parameter was varied independently under compressive, bending, and torsional load to determine the influence of that parameter on fracture stability under such loads. The interaction between these configuration parameters is complex. In general terms, fracture site stability may be increased by increasing common fragment pin separation, placing common fragment pins orthogonal to one another, increasing common fragment pin number, decreasing effective pin length, using transfixing rather than half-pins, and using as many connecting rods as possible. The difference between fracture site stability attainable with transfixing pins and with half-pins may be minimal if implementation of the other parameters combined with half-pins is optimized.     

Hydroxyapatite-coated Schanz pins in external fixators used for distraction osteogenesis : a randomized,controlled trial

BACKGROUND: Complications of external fixation include loosening of the fixation pins and pin-track infection. Laboratory studies and clinical trials have suggested that hydroxyapatite coating improves the osteointegration of various orthopaedic implants. The purpose of this study was to determine whether the prevalence of pin-related complications can be reduced by the use of hydroxyapatite-coated pins in fixators applied for distraction osteogenesis. METHODS: Forty-six consecutive patients undergoing segmental transport or lengthening of the tibia were randomized to the use of either standard titanium Schanz pins or hydroxyapatite-coated stainless-steel Schanz pins. The fixators were used for an average of thirty-eight weeks (range, fourteen to seventy-two weeks). All patients were closely monitored for pin loosening and infection, and digitized radiographs were assessed for bone resorption around all pins. When the external fixator was removed, the torque required to extract the pins was determined with use of an electronic torque wrench. RESULTS: In the control group (titanium pins), twenty-two pins (13%) loosened and an infection occurred at the site of twenty pins. An extensive infection of the canal developed in one patient. Twenty-two pins were removed or replaced because of these complications. In the hydroxyapatite group, no clinical or radiographic signs of pin loosening or infection were observed and no pins required early removal or exchange. The mean torque (and standard deviation) required to remove the hydroxyapatite-coated pins was 0.43 0.18 N-m compared with 0.10 0.09 N-m for the uncoated pins (p < 0.001). CONCLUSION: Coating pins with hydroxyapatite increases their fixation to bone and reduces the rate of infection and loosening during external fixation for distraction osteogenesis. Use of hydroxyapatite-coated pins should be considered in clinical situations requiring prolonged external fixation.     

Placement of half-pins for supra-acetabular external fixation: an anatomic study

An alternative location for placement of half-pins during pelvic external fixation is the dense supra-acetabular bone in the region of the anterior-inferior iliac spine. Although these fixators have gained popularity, to the authors' knowledge there are no studies evaluating the potential anatomic risks of placement of half-pins in this area; no safe corridors have been defined. Additionally, pins are placed near the hip capsule and no studies exist defining the superior extent of the hip capsule which potentially may be violated by placing half-pins in this location. The purposes of the current study were to evaluate the neurovascular risks and accuracy of fluoroscopically guided percutaneous placement of supra-acetabular half-pins, and to evaluate the anatomic superior extent of the hip capsule. Ten fresh frozen cadaveric pelves were used. A 5-mm half-pin was placed in the supra-acetabular bone under fluoroscopic guidance. Iliofemoral dissection was done and the proximity of the half-pin to local neurovascular risks was measured with a caliper. The hip capsule was exposed and the superior extent of the hip capsule was measured. Intraosseous pin placement was evaluated by direct observation. Nine pins were completely in bone, one had partially exited posteriorly and laterally. The lateral femoral cutaneous nerve was at risk with a mean distance of 10 mm (range, 2-25 mm) from the half-pins. The femoral nerve and femoral artery were not at risk. The average superior extent of the hip capsule was 16 mm above the joint (range, 11-20 mm). Half-pins can be placed accurately and safely in the supra-acetabular region using percutaneous techniques, appropriate soft tissue sleeves, and fluoroscopic guidance. Insertion of pins at least 2 cm above the hip is recommended to avoid potential hip capsule penetration.     

Unicortical self-drilling external fixator pins reduce thermal effects during pin insertion

Introduction

External fixation is associated with the risk of pin loosening and pin infection potentially associated to thermal bone necrosis during pin insertion.

Objective

This study aims to investigate if the use of external fixator systems with unicortical pins reduces the heat production during pin insertion compared to fixators with bicortical pins.

Methods

Porcine bone specimens were employed to determine bone temperatures during insertion of fixator pins. Two thermographic cameras were used for a simultaneous temperature measurement on the bone surface (top view) and a bone cross-section (front view). Self-drilling unicortical and bicortical pins were inserted at different rotational speeds: (30–600) rpm. Maximum and mean temperatures of the emerging bone debris, bone surface and bone cross-section were analyzed.

Results

Maximum temperatures of up to 77?±?26 °C were measured during pin insertion in the emerging debris and up to 42?±?2 °C on the bone surface. Temperatures of the emerging debris increased with increasing rotational speeds. Bicortical pin insertion generated significantly higher temperatures at low insertion speed (30 rpm)

Conclusion

The insertion of external fixator pins can generate a considerable amount of heat around the pins, primarily emerging from bone debris and at higher insertion speeds. Our findings suggest that unicortical, self-drilling fixator pins have a decreased risk for thermal damage, both to the surrounding tissue and to the bone itself.

     

Investigation of factors affecting loosening of Ilizarov ring-wire external fixator systems at the bone-wire interface

The potential for peri-implant bone yielding and subsequent loosening of Ilizarov ring-wire external fixation systems was investigated using non-linear finite element (FE) analyses. A strain-based plasticity model was employed to simulate bone yielding. FE models also incorporated contact behavior at the wire-bone interface, orthotropic elasticity, and periosteal-endosteal variation of bone properties. These simulations were used to determine the extent and location of yielding with change in age-related bone structure and properties for the bone-Ilizarov construct at the tibial midshaft. At critical wire-bone interfaces, the predicted volume of yielded bone with four wires (on either side of the fracture) was ～40% of that with two wires. Old-aged cases showed considerably greater bone yielding at the wire-bone interface than young cases (1.7-2.2 times greater volumes of yielded bone). The volume of yielded bone at all wire-bone interfaces decreased with an increase in wire pre-tension. The absence of continuous through-thickness yielding offers an explanation for the clinical observation that Ilizarov ring-wire fixation can provide stable fracture fixation even in bone with high porosity.     

Anodic plasma chemical treatment of titanium Schanz screws reduces pin loosening

OBJECTIVE: This study was designed to assess the benefits of a new Anodic Plasma Chemical calcium-phosphate (APC-CaP) surface treatment on reducing pin track infection and pin loosening in comparison to anodized titanium (Ti) during external fracture fixation. METHODS: A tibial midshaft, transverse, 6-mm gap osteotomy was created in 17 adult female Swiss alpine sheep. The tibia was stabilized with an external fixator and 4 Schanz screws of Ti or APC-CaP-treated Ti. The sheep were examined during a 12-week observation period. Infection was assessed with weekly clinical pin track grading and microbiologic assessment at sacrifice. Pin loosening was assessed by grading for radiolucency on biweekly radiographs and by measuring extraction torque on pin removal. In vivo bending stiffness measurements were performed to determine gap healing. A qualitative histologic assessment of the tissue adjacent to pin sites was also performed. RESULTS: A trend (P = 0.056) for less infection around APC-CaP pins was found at 6 weeks, but the strength of this difference diminished with time. Significantly more radiolucency was found around Ti pins after 8 (P = 0.011) and 12 (P < 0.001) weeks. At all pin sites, the extraction torque for APC-CaP pins was higher than for Ti pins (P = 0.007). No difference in the progression of gap healing was found. Histology showed bone growth at the implant surface in the form of distance osteogenesis for Ti and contact osteogenesis for APC-CaP. CONCLUSIONS: This study has shown that the APC-CaP surface improves the clinical performance of Ti pins with respect to pin loosening and pin track infection.     

Thermal response and torque resistance of five cortical half-pins under simulated insertion technique

A model was developed that can quantitate heat generation during placement of half-pins in cortical bone. Five half-pins were tested to assess differences in insertion torque, heat generation, and microdamage at the pin-bone interface. Thin thermocouple probes were placed 0.5 mm from the track of the pin and within the pin to measure its temperature during insertion. Scanning electron microscopy was used to view the pin-bone interface to assess the microdamage during placement. The design of the tip of the pin influenced insertion torque and heat generation. Higher heat generation was measured when a thermocouple was placed within the pin itself and less was measured when thermocouple probes were placed within bone samples 0.5 mm from the impending pin track. Furthermore, insertion torque and thermal responses were related, but there were no significant differences in microdamage to bone when different pins and drilling/tapping techniques were used. Due to the significant heat generation at the pin-bone interface, proper cooling with saline irrigation should be applied during pin insertion regardless of the design of the pin. The microdamage observed at the surface of the pin track may have significant implications with regard to loosening of pins, but such effects must be studied with in vivo models.     

External fixation of the pelvic ring: An experimental study on the role of pin diameter,pin position,and parasymphyseal fixator pins

Background?The mechanical properties of current external fixator systems for unstable (type C) pelvic ring fractures are inferior to internal fixation, and are not optimal for definitive treatment. We explored methods to increase stability of external fixator constructs.

Methods?An experimental model was used for load tests. The same pelvic fixator was used while different pin diameters, pin positions, and modes of pubic symphysis fixation were tested.

Results?Changing of the pin diameter of the unthreaded part from 6 to 8?mm resulted in an increase in stiffness of 20%. An increase in stiffness by a factor of 1.9 was found by placing a pin on the iliac crest and one supra-acetabular. An additional increase by a factor of 3.6 was obtained by adding pubic symphysis plate fixation. Parasymphyseal pin fixation instead reduced stiffness, but not so much as when parasymphyseal pins were connected to the external fixator of the pelvic ring. The final configuration was at least 6 times stiffer than the initial configuration.

Interpretation?The new concept of parasymphyseal pin fixation connected to an external fixator of the pelvic ring produces a considerable increase in stability for the treatment of type C pelvic ring injuries, as does an increase in pin diameter and alternative pin positioning.     

A finite element study of a fractured tibia treated with a unilateral external fixator: The effects of the number of pins and cortical thickness

IntroductionIn the early stage of fracture fixation, the aim of a unilateral external fixator (UEF) to stimulate healing and maintain stability may be suppressed by using inadequate number of pins. Cortical thinning due to age or osteoporosis endangers a successful fracture fixation.Materials and methodsThis study evaluates the initial strength and stability of the fracture fixation and tissue differentiation under the influences of variable cortical thickness (5 mm to 1 mm) and variable number of pins (1 to 4 in each bone fragment). A finite element program was utilised to develop 20 three-dimensional models of simplified diaphyseal tibia with fracture callus fixed with UEF. A mechano-regulation code based on the deviatoric strain theory was written and applied to simulate tissue differentiation. The values of von Mises stress, interfragmentary strain (IFS), and fibrocartilage index (FCI) were evaluated.ResultsCortical thinning from 5 mm to 1 mm increased IFS and FCI by an average of 30.3% and 18.7%, respectively, and resulted in higher stresses in the UEF and bone. Using 1 pin in each bone fragment produced excessive IFS in the models with 1 mm, 2 mm and 3 mm cortical thickness. Inserting the second pin into the bone fragment could considerably reduce the IFS and fibrocartilaginous tissue formation in the fracture site and improve load transmission to the fixator. Whereas inserting the fourth pin could minimally affect the mechano-biological environment of healing.ConclusionsThis study suggests that initial instability due to cortical thinning can be efficiently alleviated by adding the number of pins up to 3 in a UEF; additionally, it may improve the knowledge about applying UEFs adequately stable, whilst promoting inclination toward endochondral ossification, simultaneously.     

Antimicrobial efficacy of external fixator pins coated with a lipid stabilized hydroxyapatite/chlorhexidine complex to prevent pin tract infection in a goat model.

BACKGROUND: Pin tract infection is a common complication of external fixation. An antiinfective external fixator pin might help to reduce the incidence of pin tract infection and improve pin fixation. METHODS: Stainless steel and titanium external fixator pins, with and without a lipid stabilized hydroxyapatite/chlorhexidine coating, were evaluated in a goat model. Two pins contaminated with an identifiable Staphylococcus aureus strain were inserted into each tibia of 12 goats. The pin sites were examined daily. On day 14, the animals were killed, and the pin tips cultured. Insertion and extraction torques were measured. RESULTS: Infection developed in 100% of uncoated pins, whereas coated pins demonstrated 4.2% infected, 12.5% colonized, and the remainder, 83.3%, had no growth (p < 0.01). Pin coating decreased the percent loss of fixation torque over uncoated pins (p = 0.04). CONCLUSION: These results demonstrate that the lipid stabilized hydroxyapatite/chlorhexidine coating was successful in decreasing infection and improving fixation of external fixator pins.     

The Rancho mounting technique for the Ilizarov method. A preliminary report.

To improve implant tolerance and muscle function associated with circular external fixation, the authors substituted divergent titanium pins for the tensioned steel wires used to mount the Ilizarov apparatus on a limb. The first ten patients treated with half-pins were compared to the last ten patients managed with tensioned wires. While the conditions were not exactly comparable, the half-pin group showed improvement over the wire group in categories including time in fixation, implant-site sepsis, range of joint motion, pain medication requirements, and ambulatory capacity. Half-pin mountings require special techniques for a successful application.     

Rigidity of half-pins for the Ilizarov external fixator.

The success of the Ilizarov technique is due to the combination of the biomechanics of its external fixator and the biology of distraction osteogenesis. The stability and stiffness of the conventional Ilizarov fixator is attributed to its use of a K-wire cross structure. The disadvantages of this structure include pain, and possible neurologic and vascular injuries when the wires are introduced into crucial neurovascular areas, as well as increased frame complexity and construction. Reducing the number of wires decreases these problems, but also decreases the stiffness of the system. Hybrid (wire and half-pins) Ilizarov fixators and half-pin fixators are also being used in an attempt to alleviate these problems. Half-pins have been described by Fleming et al. and Green as causing minimal transfixation of the surrounding soft tissues and capable of and being inserted into anatomically safe areas. The stiffnesses of the hybrid systems have not been measured. This study reports on the stiffness of different wire and half-pin systems that were biomechanically tested in axial loading, anterior-posterior bending, medial-lateral bending, and torsional loading. The results demonstrated that the conventional Ilizarov fixator with wires possesses a high axial stiffness, whereas the fixator with half-pins possesses higher stiffness under bending and torsional loads. To obtain adequate stability, the use of hybrid Ilizarov frames with one wire and two or more half-pins (5 or 6 mm in diameter), or larger half-pin frames (5 or 6 mm) with three pins is recommended.     

Inferior fixation with a new pin design for external fixation: A randomized study in 50 patients operated on by the hemicallotasis technique

Background and purpose?Tibial osteotomy by the hemicallotasis technique (HCO) requires strong pin fixation. We compared pin fixation in HCO using a new self-drilling XCaliber pin (Orthofix) with optimized thread and tip design, with the commonly used standard pin (Orthofix).

Patients and methods?50 patients, mean age 51 (35–66) years, to be treated by HCO were randomized to standard pins or XCaliber pins. In the metaphyseal bone, hydroxyapatite-coated (HA-coated) pins were used in both types of pins. In the diaphyseal bone, non-coated pins were used. The torque forces for insertion and extraction (in Nm) were measured.

Results?The insertion torque was higher for both the proximal and distal standard pins (2.1 Nm (SD 0.9) and 7.0 Nm (1.3), respectively) than for the XCaliber pins (1.3 Nm (0.8) and 3.6 Nm (1.4)). The extraction torque force was higher for the proximal standard pins (4.3 Nm (3.1)) than for the proximal XCaliber pins (1.5 Nm (1.7)) (p < 0.001). The extraction torque for the distal standard pins was 1.9 Nm (2.0) and for the distal XCaliber pins it was 1.4 Nm (1.1).

Interpretation?The commonly used standard pin gives stronger fixation during the treatment of HCO.     

Behavior of an external fixation frame incorporating an angular separation of the fixator pins. A finite element approach

A finite element model has been developed to simulate the deformation that occurs at the fracture site of an externally fixed bone as a result of applied bending, compression, and torsional loads. The pin configuration in this model is constructed to allow an angular separation of the fixator pins. The mechanical effect of this angular separation and of the distribution of the pins along the fixator bar is examined. The model shows that an angular separation of the pins provides a more symmetric deformation of the fracture site when a bending load is applied in different directions to the bone and thereby protects a fracture from excessive movement in any direction. The torsional stability of an external fixation frame is considerably increased by incorporating an angular separation of the pins. The model also shows that the most stable configuration for the fixator uses a wide separation of the pins along the fixator bar.     

Induction and prevention of pin loosening in external fixation: an in vivo study on sheep tibiae.

In external fixation of fractures, pin loosening is a major concern. Preloading the pins is generally done to ensure their stability within the bone cortex. The effect of radial preload and bending preload in reducing resorption at the pin/bone interface was tested. Schanz screws were fixed to live sheep tibiae using a pneumatically operated external fixator frame. Evaluation was based on radiological observation and fluorochrome histology using sequential labels. Though not completely absent, bone resorption was minimal in the radial preload group, compared with the two other groups. More important, the bone-to-pin contact surface in the radial preload group was found to be almost intact after 5 weeks. In this study, radial preload appears to be superior to bending preload in terms of minimizing the problems of pin loosening.     

AO external fixator for definitive treatment of an open distal tibia fracture during the COVID-19 pandemic

BackgroundThe accepted gold standard for primary treatment of long bone open fractures consists of aggressive debridement, irrigation and temporary external fixation. Removal of the external fixator followed by definite internal fixation is recommended within the first two weeks after the injury to obtain a more stable fixation, alleviate rehabilitation and to avoid pin infection.Materials & MethodsHere, we report a case of a Gustilo IIIB open tibia fracture with extended soft tissue degloving of the distal tibia. Following removal of the AO external fixator, plate fixation and soft tissue coverage with a free flap, implant loosening occurred warranting a return to external fixation. The patient did not return for follow-up due to a prolonged COVID-19-quarantine and no further treatment was installed.Results & ConclusionsThe patient returned after 6 months with the fractures and soft tissues fully healed. In specific situations, the external fixator may be used as a definitive form of treatment.     

Complications at screw removal in slipped capital femoral epiphysis treated by cannulated titanium screws

Introduction: Various modes of fixation are proposed for the treatment of slips of the capital femoral epiphysis (SCFE). We describe our experience with the use and removal of a new, cannulated titanium screw (Asnis III, Stryker^®, Howmedica). Patients and methods: Single cannulated titanium screws had been inserted in 101 hips of 65 patients in the 3-year period from 2001 to 2003. These pins were used for in situ fixation of minor chronic slips in 41 patients and for prophylactic fixation on the contralateral side in patients with open physis in 60 patients. Results: The insertion of these screws was achieved without any real problem. The mean surgical time was 25 min (13–46 min). Problems came up when we started to remove the pins. Hardware retrieval was attempted in 27 patients with 43 pins. The mean surgical time for removal was double the average time of insertion with 51 min (26–107 min). The hexagonal Allen sockets proved to be too weak to overcome the necessary torque for loosening the pin from bone and applying the reverse-cutting-force, necessary to extract the pin. Eleven patients needed extensive chiselling. Two adolescents sustained a subtrochanteric fracture 5 and 7 weeks after hardware removal. Seven pins could not be totally removed. Conclusion: Due to the considerable disadvantages encountered in our series we conclude that Asnis III cannulated screws should be suspended from further use in SCFE.     

A comparison of two techniques for digital distraction lengthening in skeletally immature patients

Since 1987, 16 skeletally immature patients aged 2 to 16 years (mean, 7.9 years) underwent 27 digital lengthening procedures of terminal bones, 20 metacarpals and 7 phalanges, using the distraction callotasis technique. Seven digits were lengthened with 2 fixator half-pins on either side of the osteotomy site (dual half-pin group). Twenty digits, which were too small to accommodate 4 half-pins, were lengthened over a longitudinal intramedullary guidewire with 1 fixator half-pin on either side of the osteotomy site (single half-pin/K-wire group). No bone grafts were needed. The mean preoperative bone length in the dual half-pin group was 30 mm (range, 23-40 mm) and that of the single half-pin/K-wire group was 18 mm (10-30 mm). The mean total length gained was 14 mm (9-23 mm) in the dual half-pin group and 12 mm (6-19 mm) in the single half-pin/K-wire group. The mean percent lengthened was 49% (22% to 96%) in the dual half-pin group and 70% (27% to 136%) in the single half-pin/K-wire group. Eighteen complications occurred: 15 in the 20 cases using the central guidewire (75%) and 3 in the 7 cases without the central guidewire (43%). Only 7 complications required repeat surgery. We conclude that the use of the single half-pin/K-wire technique allows successful and substantial lengthening for bones shorter than 23 mm, making correction surgery possible for younger children. This technique, however, has a greater risk for complications.     

Stabilization of a short juxta-articular bone segment with a circular external fixator

The objective of the current study was to evaluate the stabilization of a simulated juxta-articular bone segment with a circular external fixator, and to determine which method of fixation improved bending stabilization while preserving the axial dynamization of a three-wire configuration. Frames were divided into three groups: wire, half-pin and hybrid and tested in axial compression, torsion, anteroposterior bending and mediolateral bending. Hybrid frames using 4 mm half-pins improved the anteroposterior stabilization of the short bone segment while maintaining axial characteristics similar to a three-wire frame. Increasing the bending stabilization will improve bone segment alignment while permitting axial micromotion beneficial to bone healing.