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1.
In a multicenter, prospective, randomized study, the biomechanical and clinical properties of the bone-pin interface were compared with standard tapered pins and hydroxyapatite-coated tapered pins implanted in patients who underwent femoral and tibial external fixation treatments. The results showed that the hydroxyapatite-coated tapered pins are clinically effective in improving the strength of fixation of the bonepin interface. This improvement corresponded to a lower rate of pin tract infection. In the hydroxyapatite-coated pin group, there were no differences in strength of fixation between the pins removed from the infected and uninfected pin tracts. In this pin group, the mean pin extraction torque was 531 +/- 225 Ncm in the infected pin tracts and 508 +/- 233 Ncm in the uninfected pin tracts. In the standard pin group, the mean pin extraction torque was 73 +/- 142 Ncm in the infected pin tracts and 211 +/- 216 Ncm in the uninfected pin tracts. The advantages provided by the hydroxyapatite-coated pins were higher in cancellous bone than in cortical bone.  相似文献   

2.
OBJECTIVE: To test the null hypothesis that osseomechanical integration is not related to the maximum insertion torque of tapered external fixation pins. DESIGN: Prospective in vivo study in a functionally loading ovine model. In 12 animals, tapered commercial external fixation pins were inserted at predefined locations with measured insertion torques and extraction torque measured at 10 weeks postoperatively. SETTING: Unrestricted stall activity under veterinary supervision. INTERVENTIONS: Under general anesthesia and aseptic conditions, mid-diaphyseal tibial osteotomies were created and a 3-mm gap width stabilized with a custom-made, high-precision, single-sided external fixator, in compliance with United Kingdom government regulations [Animals (Scientific Procedures) Act 1986]. MAIN OUTCOME MEASUREMENTS: Primary pin site stability and interface load were assessed by measuring maximum insertion torque (Nm). At a 10-week postoperative end point, osseomechanical stability was assessed by measuring the extraction torque and a pin performance index determined from the insertion/extraction torque ratio. RESULTS: A positive correlation was found between extraction torque and insertion torque (R2 = 0.322, P < 10(-6)). All pins with an insertion torque equal to or greater than 7 Nm had a measurable extraction torque, as did 98% of the pins with an insertion torque above 5 Nm. Extraction torque decreased both as a function of pin site position by the postoperative end point. High insertion torques were found to enhance end point stability in both diaphyseal and metaphyseal bone. CONCLUSION: The data from this study indicate that tapered external fixation pins should be inserted with a high torque to enhance the long-term integrity of the pin-bone interface.  相似文献   

3.
BACKGROUND: Achieving adequate fixation strength in osteoporotic bone is a challenge. In this study, we examined the use of hydroxyapatite-coated tapered external-fixation pins for the fixation of wrist fractures in patients with osteoporosis. METHODS: Twenty female patients with osteoporosis and a fracture of the wrist were divided into two paired groups and randomized to receive either standard tapered pins or hydroxyapatite-coated tapered pins. Two pins were inserted in the distal part of the radius, two pins were inserted in the second metacarpal, and an external fixation device was mounted. All fixation devices were removed six weeks after surgery. RESULTS: The mean pin-insertion torque (and standard deviation) was 461 +/- 254 Nmm in the group managed with standard pins and 332 +/- 176 Nmm in the group managed with hydroxyapatite-coated pins (p = 0.01). The mean pin-extraction torque was 191 +/- 155 Nmm in the group managed with standard pins and 600 +/- 214 Nmm in the group managed with hydroxyapatite-coated pins (p < 0.0001, power 95%). The mean extraction torque was lower than the corresponding insertion torque at each pin position in the group managed with standard pins (p < 0.05), whereas the mean extraction torque was higher than the corresponding insertion torque at each pin position in the group managed with hydroxyapatite-coated pins (p = 0.001). Two patients managed with standard pins and no patient managed with hydroxyapatite-coated pins had a pin-track infection. Pain during pin removal did not differ between the two groups. CONCLUSIONS: The present study showed that hydroxyapatite-coated tapered external-fixation pins provided improved fixation in the treatment of wrist fractures in patients with osteoporosis.  相似文献   

4.
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.  相似文献   

5.
6.
External fixator pin design.   总被引:2,自引:0,他引:2  
The integrity of the bone-pin interface is the critical link in the stability of external fixation systems. External fixation pins placed in cancellous metaphyseal bone frequently loosen over time, resulting in fixation failure and an increased risk of infection. To design an external fixation pin with optimal bone-metal interface strength in cancellous bone, a systematic study of various thread design features was performed. Combinations of pitch, tooth profile, and minor diameter in 5 mm self-tapping half pins were evaluated in coaxial pullout testing using a fresh bovine cancellous bone. A significant increase in pullout strength was found with a decrease in minor diameter. No statistical differences were found in pullout strength attributable to thread profile and pitch. There were no significant interactions between minor diameter and tooth profile or minor diameter and pitch. The data obtained suggest significantly greater holding power in cancellous bone can be achieved by using an external fixation pin with a smaller minor diameter or a larger interference. Additional pullout testing of five commercially available external fixator pins was performed. Of these, the two pins with the largest interference demonstrated greater pullout strength. Therefore, within a range of acceptable major diameters and adequate minor diameters for the torsional strength requirements, an optimal interference for cancellous pin application may exist and it may well be larger than that present in currently available external fixation pins.  相似文献   

7.
To evaluate soft tissue reactions and biofilm formation on percutaneous external fixator screws coated with diamond-like carbon (DLC) and hydroxyapatite (HA) coatings on stainless-steel (SS) pins in an ovine loaded osteotomy model, an Orthofix external fixator was used to stabilize a 3-mm tibial midshaft osteotomy with six tapered pins inserted into the right tibia of 32 skeletally mature Friesland ewes. Animals were divided into four groups; SS, fully coated HA, DLC, and HA-coated threads. At 10 weeks, specimens were harvested and the pins were removed en bloc to examine the interfaces between the surface coatings and the tissues. Fully coated HA pins had a significantly higher percentage of dermal contact with the pin surface than HA-coated threads (p=0.028). The presence of a biofilm was evident on all pin surfaces except DLC-coated pins. Significantly greater numbers of bacteria were present on fully coated HA and plain stainless-steel pins compared with DLC. The surface of DLC-coated pins had a significantly lower number of bacterial colonies compared to SS (p=0.028) and fully coated HA pins (p=0.005). Fully coated HA pins have greater dermal attachment to the pin surface than the other pin coatings investigated. DLC-coated pins have the potential to prevent biofilm formation and bacterial colonization that may reduce infection and consequent pin loosening. An external fixator pin that is partially coated with HA to encourage bone and soft tissue integration and with DLC to reduce biofilm formation is advocated.  相似文献   

8.
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.  相似文献   

9.
The authors evaluated whether AO/ASIF screws coated with hydroxyapatite are better fixed than standard screws in a highly loaded plate fixation animal study. Twelve sheep were divided into two groups. The medial tibial middiaphysis was exposed and a 5-mm long bone cylinder was removed. The tibiae were fixed with six-hole dynamic compression plates. Six sheep received standard AO/ASIF stainless steel cortical screws (Group A), and six sheep received AO/ASIF stainless steel cortical screws coated with hydroxyapatite (Group B). Three months after surgery, the sheep were euthanized. The mean screw insertion torque was 4800 +/- 768 N/mm in Group A and 4847 +/- 450 N/mm in Group B. The mean screw extraction torque was 530 +/- 374 N/mm in Group A and 3733 +/- 849 N/mm in Group B. Extraction torque of Group A was significantly lower compared with the corresponding insertion torque. In Group B, there were no differences between extraction and insertion torque. Morphologic analyses showed marked fibrous tissue encapsulation in Group A and bone to screw direct contact in Group B. The results confirm that hydroxyapatite-coated AO/ASIF screws prevent deterioration of screw anchorage, even under highly loaded conditions. By using hydroxyapatite-coated screws, complications resulting from inadequate fixation could be avoided.  相似文献   

10.
OBJECTIVE: To evaluate whether coating AO/ASIF screws with osteoconductive materials can improve bone-screw fixation. DESIGN: Ninety-six AO/ASIF 4.5-millimeter cortical screws were divided into four paired groups and implanted in the femurs and tibiae of six sheep: Group A = standard stainless steel screws; Group B = stainless steel screws coated with highly crystalline hydroxyapatite; Group C = stainless steel screws coated with low crystalline hydroxyapatite; Group D = titanium screws coated with titanium. The screws were implanted according to the standard AO technique to an insertion torque of 2,000 Newton-millimeters. Sheep were killed at one, three, and twelve months after surgery. MAIN OUTCOME MEASURES: Extraction torque was measured on six screws from each group selected at random at time of each euthanization. Morphologic analysis of the bone-screw interface was performed on the remaining screws. RESULTS: At each euthanization the extraction torque of Group A was lower than that of the other groups (p < 0.0001). At three and twelve months the extraction torque of Group B was higher than that of Group D (p = 0.002). Morphologic results showed extensive bone-screw gap in Group A. Optimal osteointegration was observed in Groups B and C. Osteointegration of Group D was higher than that of Group A and lower than that of Groups B and C. CONCLUSIONS: It was demonstrated that AO/ASIF screws coated with osteoconductive materials achieve optimal fixation strength, even in the early phase. This fixation strength was significantly higher than that of the standard screws.  相似文献   

11.
Pin loosening and infection are inherent complications of external fixation. This study deals with their effects of using either hydroxyapatite (HA)-coated or uncoated external fixation pins in leg-lengthening procedures on patients of short stature. We used HA-coated pins on one side and uncoated pins on the other (randomly determined) in 28 bilateral lengthenings undertaken in 23 patients. A total of 322 pins was used. The mean implantation time was 530 days and the mean lengthening achieved was 78% of initial bone length. Mean extraction torque was 7611.6 Nmm degree(-1) for HA-coated and 85.4 Nmm degree(-1) for uncoated pins (p < 0.001). The rate of pin loosening was 4% (7/161) for HA-coated and 80% (129/161) for uncoated pins (p < 0.001). There was no statistically significant difference in the incidence of pin-track infection between the two groups. The use of HA coating appears to be an effective method of reducing the incidence of pin loosening in external fixation with a long implantation time and for mechanically highly stressed procedures such as leg lengthening for short stature.  相似文献   

12.
《Acta orthopaedica》2013,84(1):48-52
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.  相似文献   

13.
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.  相似文献   

14.
Surgical drilling and pin insertion can lead to mechanical and thermic damage of the bone. A methodology giving reproducible in vitro records of insertion and holding parameters of threaded implants is presented. Both drilling and tapping are related to the cutting technology. To understand the basic principles of the cutting technology some important parameters of drilling and tapping of an external fixation pin are defined. A bone model was selected based on specific mechanical and thermal properties of the bone tissue. In addition, a specific instrumentation was designed in order to compare the insertion characteristics and the anchorage of different pins. Electronic scanning microscopy of the samples was systematically performed to evaluate the quality of the bone thread. The in vitro measurements of the shearing torque and the pull-out force are representative of the immediate holding power of a pin. The different holding parameters were then correlated. Temperature measurements were performed during drilling, smooth part penetration (transfixing pins), tapping, and screwing. The final objective of the study was to develop new threaded implants with better biomechanical characteristics.  相似文献   

15.
Alendronate improves screw fixation in osteoporotic bone   总被引:3,自引:0,他引:3  
BACKGROUND: Animal studies have demonstrated the efficacy of the use of bisphosphonates to enhance screw fixation in bone. In this prospective, randomized study of pertrochanteric fractures treated with external fixation, we tested whether systemic administration of bisphosphonates would improve the fixation of hydroxyapatite-coated screws implanted in osteoporotic bone. METHODS: Sixteen consecutive patients with a pertrochanteric fracture were selected. Inclusion criteria were female gender, an age of at least sixty-five years, and a bone mineral density T-score of less than -2.5 standard deviations. Exclusion criteria included bisphosphonate treatment during the two-year period prior to the fracture. Fractures were fixed with a pertrochanteric fixator and four hydroxyapatite-coated pins. Two pins were implanted in the femoral head (pin positions 1 and 2), and two were placed in the femoral diaphysis (pin positions 3 and 4). The patients were randomized either to therapy with alendronate for a three-month postoperative period (Group A) or to no therapy (Group B). The Group-A patients received an oral dose of 70 mg of alendronate per week. The fixators were removed after three months. RESULTS: All of the fractures healed, and no loss of reduction, nonunion, or delayed union was observed. The combined mean extraction torque (and standard deviation) of the pins implanted at positions 1 and 2 (cancellous bone) was 2558 +/- 1103 N/mm in Group A and 1171 +/- 480 N/mm in Group B (p < 0.0005). The combined mean extraction torque of the pins implanted at positions 3 and 4 (cortical bone) was 4327 +/- 1720 N/mm in Group A and 4075 +/- 1022 N/mm in Group B. CONCLUSIONS: These data show that weekly systemic administration of alendronate improves pin fixation in cancellous bone in elderly female patients with osteoporosis. We observed a twofold increase in extraction torque with the pins implanted in cancellous bone. These results support the use of alendronate in the treatment of osteoporotic pertrochanteric fractures to improve screw fixation in the femoral head.  相似文献   

16.
The effect of pin location on the rigidity of the halo pin-bone interface   总被引:1,自引:0,他引:1  
Optimal insertion of halo fixation pins to maximize the rigidity of the interface between the halo pins and the outer table of the skull is important in reducing the incidence of pin loosening. An in vitro biomechanical study was performed using cadaver skulls to investigate the effects of pin location on the rigidity of this pin-bone interface. Halo pins were inserted at nine positions within a recommended "safe zone" for pin insertion. It was found that the rigidity of the pin-bone interface progressively decreased as pins were inserted more superiorly on the calvaria. The rigidity of the interface did not change significantly when the location of the pins was varied in the horizontal axis. This reduction in interface rigidity associated with inserting pins more superiorly on the skull may be related to an increase in the angle of insertion of the pins with respect to the surface of the calvaria. Based on this study, a change in the technique of halo pin insertion is recommended. Pins should be placed as inferiorly as possible, close to the supraorbital ridge, to achieve the most perpendicular angle of insertion and thus the most rigid fixation. The improved rigidity obtained with perpendicular pin insertion may minimize the rate of pin loosening and other complications associated with use of the halo orthosis.  相似文献   

17.
The intent of this study was to investigate the stress distribution in cortical bone around fracture fixation pins and around pins coated with various polymeric and elastomeric materials. Since these interface stresses cannot be measured directly, a photoelastic technique was employed and stresses were measured in two-dimensional bone models fabricated from sheets of epoxy resin. Our results showed that when a fixation pin was loaded in compression, the compressive stress measured in the model was greatest at the pin–model interface. The magnitude of the compressive stress was found to diminish steeply away from the hole in a log decrement distribution which was asymptotic to the value of the average stress in the model. When polymeric and elastomeric materials were applied as pin coatings and the performance of the coated pins was compared to that of uncoated pins of the same overall diameter, a reduction of the maximum stress in the bone model was demonstrated. Among the coatings tested, we found that of the polymeric materials ultrahigh molecular weight polyethylene (UHMWPE) was most effective at reducing the peak cortical stress magnitude. The most effective coating material overall was found to be silicon elastomer. Computation of stress values in models loaded through stainless-steel pins and through pins coated with 1-mm silicon elastomer showed that the presence of the elastomer layer caused a reduction of about 50% in the maximum compressive stress in the model.  相似文献   

18.
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.  相似文献   

19.
The in vivo effects of coating titanium implants with organic extracellular matrix molecules were examined in the sheep tibia. Titanium screws (5.0 mm) were coated with type I collagen (Ti/Coll) or type I collagen and chondroitin sulfate (Ti/Coll/CS) by biomimetic fibrillogenesis. Uncoated screws (Ti) and screws coated with hydroxyapatite (Ti/HA) served as control. Six adult female sheep received one screw of each type to stabilize a midshaft tibial fracture with external fixation. Four cylindrical implants of 4-mm outer diameter and 3.3-mm inner diameter with the same coatings were inserted into the tibial head. No pin track infections were seen at the time of implant retrieval 6 weeks after implantation. Extraction torque was greater for Ti/HA (1181 Nmm) and Ti/Coll/CS (1088 Nmm) compared to Ti/Coll (900 Nmm) and Ti (904 Nmm) [N.S.]. Newly formed bone was noted around all coated screws within the medullary cavity. Macrophage and osteoclast activity was significantly reduced around Ti/Coll/CS in both types of implants compared to uncoated controls (p < 0.05). Osteoblast activity was significantly increased around loaded Ti/Coll and Ti/Coll/CS screws compared to uncoated Ti screws (p < 0.05). Microtomographic evaluation (SRmicroCT) revealed no significant differences in new bone formation around the unloaded tibial head implants.Coating of external fixation devices with of type I collagen and chondroitin sulfate appears to have similar effects with respect to stability and bone healing as HA but with less osteoclast activity. These findings were more pronounced under loaded than unloaded conditions in the sheeptibia.  相似文献   

20.

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.
  相似文献   

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