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Complications of Titanium and Stainless Steel Elastic Nail Fixation of Pediatric Femoral Fractures
Eric J. Wall, MD1; Viral Jain, MD1; Vagmin Vora, MD2; Charles T. Mehlman, DO, MPH1; Alvin H. Crawford, MD1
1 Division of Pediatric Orthopaedic Surgery, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Cincinnati, OH 45229-3039
2 Department of Orthopaedics and Rehabilitation, Penn State Hershey Medical Center, Penn State Hershey College of Medicine, Mail Code EC 089, 30 Hope Drive, Building A, Hershey, PA 17033
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Disclosure: The authors did not receive any outside funding or grants in support of their research for or preparation of this work. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. Commercial entities (DePuy Spine, Synthes Spine, Medtronic) paid or directed in any one year, or agreed to pay or direct, benefits in excess of $10,000 to a research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which one or more of the authors, or a member of his or her immediate family, is affiliated or associated.
Investigation performed at the Division of Pediatric Orthopaedic Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio

The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2008 Jun 01;90(6):1305-1313. doi: 10.2106/JBJS.G.00328
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Abstract

Background: In vitro mechanical studies have demonstrated equal or superior fixation of pediatric femoral fractures with use of titanium elastic nails as compared with stainless steel elastic nails, and the biomechanical properties of titanium are often considered to be superior to those of stainless steel for intramedullary fracture fixation. We are not aware of any clinical studies in the literature that have directly compared stainless steel and titanium elastic nails for the fixation of pediatric femoral fractures. The purpose of the present study was to compare the complications associated with the use of similarly designed titanium and stainless steel elastic nails for the fixation of pediatric femoral fractures.

Methods: A group of fifty-six children with femoral fractures that were treated with titanium elastic nails was compared with another group of forty-eight children with femoral fractures that were treated with stainless steel elastic nails. Both nail types were of similar design, and a similar retrograde insertion technique was used. The groups were compared with regard to complications as well as insertion and extraction time. Major complications were defined as malunion with sagittal angulation of >15° and coronal angulation of >10°, nail irritation requiring revision surgery, infection, delayed union, and rod breakage. Minor complications were defined as nail irritation or superficial infection not requiring surgery.

Results: The malunion rate was nearly four times higher in association with the titanium nails (23.2%; thirteen of fifty-six) as compared with the stainless steel nails (6.3%; three of forty-eight) (p = 0.017, chi-square test; odds ratio = 4.535 [95% confidence interval, 1.208 to 17.029]). The rate of major complications was 35.7% (twenty of fifty-six) for titanium nails and 16.7% (eight of forty-eight) for stainless steel nails. The rates of minor complications were similar for the two groups, as were the insertion times and extraction times. The supplier price of one titanium nail ranges from $259 to $328, depending on size, whereas the price of one stainless steel nail would be $78 in current United States dollars.

Conclusions: Our results indicate that the less expensive stainless steel elastic nails are clinically superior to titanium nails for pediatric femoral fixation primarily because of a much lower rate of malunion.

Level of Evidence: Therapeutic Level III. See Instructions to Authors for a complete description of levels of evidence.

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    References

    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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    Eric J. Wall, MD
    Posted on October 27, 2009
    Dr. Wall and colleagues respond to Dr. Thakkar
    Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio

    Thank you for your comments and the questions. Following are our answers to your questions:

    1. How many patients had a mismatch in nail (TEN or SS elastic) diameter as seen in Fig 2-B (the nails are of a different diameter)?

    Except for the patient illustrated, none of the other 15 patients with malunion had any mismatching of the nails. Overall, less than 5% of our patients had mismatched nail placement, the patients were evenly distributed among the stainless steel and titanium groups (three and two respectively).

    2. Did you use more than two nails in any single case?

    We have found that a child who weighs more than 40 kg or is over 11 years of age requires more than two nails; otherwise, malunion may occur. We have not used more than 2 nails in any of our patients in the study except the two cases of implant breakage.

    3. In the case of breakage, was it breakage of both nails (all nails in a single case) or just one of the nails and was there malunion in that case? How much did that patient weigh?

    We had two cases of nail breakage. The nail breakage was seen in one patient with titanium nails with a resultant malunion. Only one nail was broken. This was treated by re-reduction and introduction of a third nail. The other patient had stainless steel nails, which did show breakage of one nail without malunion (according to our criteria) and was treated by insertion of a third nail.

    4. You have mentioned that the stainless steel nails were custom made to order. Which type of steel material was used, 316L or 316LVM? What were the mechanical properties in terms of ultimate tensile strength and percentage of elongation upon tensile stress? Which company made the custom-made nails? Can you tell us whether the stainless steel nails were more flexible than the TEN nails supplied by Synthes (Synthes, Paoli, Pennsylvania)?

    Howmedica (Rutherford, NJ) was the supplier of the stainless steel nails. The company was integrated into Stryker in the year 1999. All of our stainless steel nails were 316LVM. Mechanical testing of these nails was not done for the present study. According to the surgeons’ clinical experience, the titanium nail feels more flexible than the stainless steel nail (1-3).

    References

    1. Mahar AT, Lee SS, Lalonde FD, Impelluso T, Newton PO. Biomechanical comparison of stainless steel and titanium nails for fixation of simulated femoral fractures. J Pediatr Orthop. 2004;24:638-41.

    2. Mani US, Sabatino CT, Sabharwal S, Svach DJ, Suslak A, Behrens FF. Biomechanical comparison of flexible stainless steel and titanium nails with external fixation using a femur fracture model. J Pediatr Orthop. 2006;26:182-7.

    3. Arens S, Schlegel U, Printzen G, Ziegler WJ, Perren SM, Hansis M. Influence of materials for fixation implants on local infection. An experimental study of steel versus titanium DCP in rabbits. J Bone Joint Surg Br. 1996;78:647-51.

    Navin N. Thakkar
    Posted on October 04, 2009
    Complication Comparison of Titanium and Stainless Steel Elastic Nails
    Pragna Orthopedic Hospital, Ahmedabad, India

    To the Editor:

    I read the article by Wall et al. (1) with great interest. It is a really interesting observation and we are also having the same experience in our practice. I would like to know from your data, which is not mentioned in your article:

    1. How many patients had a mismatch in nail (TEN or SS elastic) diameter as seen in Fig 2-B (the nails are of a different diameter)?

    2. Did you use more than two nails in any single case? We have found that a child who weighs more than 40 kg or is over 11 years of age requires more than two nails; otherwise, malunion may occur.

    3. In the case of breakage, was it breakage of both nails (all nails in a single case) or just one of the nails and was there malunion in that case? How much did that patient weigh?

    4. You have mentioned that the SS nails were custom made to order. Which type of steel material was used, 316L or 316LVM? What were the mechanical properties in terms of ultimate tensile strength and percentage of elongation upon tensile stress? Which company made the custom-made nails? Can you tell us whether the stainless steel nails were more flexible than the TEN nails supplied by Synthes (Synthes, Paoli, Pennsylvania)?

    The author did not receive any outside funding or grants in support of his research for or preparation of this work. Neither he nor a member of his immediate family received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the author, or a member of his immediate family, is affiliated or associated.

    Reference

    1. Wall EJ, Jain V, Vora V, Mehlman CT, Crawford AH. Complications of titanium and stainless steel elastic nail fixation of pediatric femoral fractures. J Bone Joint Surg Am. 2008;90:1305-13.

    Eric J. Wall, MD
    Posted on February 04, 2009
    Dr. Wall and colleagues respond to Dr. Gulati and colleagues
    Cincinnati Children's Hospital

    We thank Drs. Gulati, Aggarwal and Singh for their thoughtful comments and are pleased to respond.

    The malunion rate for titanium nails in our study was 23.2%, however the overall malunion rate for both nails was 15%. Ho et al. have reported malunion rates from 17-24% depending on the duration of follow-up (1).

    Although the manufacturer of the titanium nail has suggested subsequent nail removal, they do not provide guidelines for the timing of nail removal. In the literature the times of nail removal range from 3 months to 1 year (2-4). Metaizeau recommends routine removal between 3-6 months after the insertion (4,5). It is our experience that waiting more than 6 months makes removal of elastic nails difficult.

    We routinely remove the elastic nails when there is radiographic circumferential callus formation and an absence of the fracture line. In our study, the average nail removal times were not significantly different between stainless steel and titanium groups (130 vs. 147 days, respectively p=0.356). Furthermore, none of the patients who had malunion demonstrated an increase in angulation when comparing their pre-extraction x-rays to those at final follow up. Therefore, we disagree that early nail extraction was associated with higher malunion rates.

    Early weight-bearing following the use of elastic nailing should be discouraged. Others have recommended waiting for 3-8 weeks before full weight bearing is started (1,3,4). Metaizeau has recommended that partial weight bearing can be started at the beginning of the 3rd week with progression to full weight bearing shortly thereafter (5). We typically wait 4 weeks before beginning weight bearing in our patients after ensuring good callus formation at the fracture site.

    We did not specifically measure time to union which occurred rapidly in all but one patient. All fractures were completely united at the time of nail removal. We compared the variables of fracture pattern, age, weight, weight-nail ratio, nail-canal diameter ratio (0.4 rule) and metal type in a multivariate analysis and found that only nail material was significantly associated with malunion.(p=0.025 ); stainless steel was significantly superior to titanium.

    References

    1. Ho CA, Skaggs DL, Tang CW, Kay RM. Use of flexible intramedullary nails in pediatric femur fractures. J Pediatr Orthop 2006; 26(4):497-504.

    2. Flynn, J.M., et al., Titanium elastic nails for pediatric femur fractures: a multicenter study of early results with analysis of complications. J Pediatr Orthop, 2001. 21(1): p. 4-8.

    3. Linhart, W.E. and A. Roposch, Elastic stable intramedullary nailing for unstable femoral fractures in children: preliminary results of a new method. J Trauma, 1999. 47(2): p. 372-8.

    4. Ligier JN, Metaizeau JP, Prevot J, Lascombes P. Elastic stable intramedullary nailing of femoral shaft fractures in children. J Bone Joint Surg Br 1988; 70(1):74-7.

    5. Metaizeau, J.P., Stable elastic intramedullary nailing for fractures of the femur in children. J Bone Joint Surg Br, 2004. 86(7): p. 954-7.

    Divesh Gulati
    Posted on January 14, 2009
    Complications of Elastic Nail Fixation of Pediatric Femoral Fractures
    University College of Medical Sciences, New Delhi, India

    To the Editor:

    We read with interest the article by Wall et al. (1) in which they report a 23.2% rate of malunion with use of titanium elastic nails in pediatric femoral fractures. This rate is unusually high when compared to similar published studies in which the rate of malunion using this device is approximately 10% (2-8).

    The average time of recommended implant removal is between 6 months to 1 year when circumferential callus appears to be solid and the fracture line is no longer visible (4,7,8). However, the authors extracted the implant at an average of 4.5 months following insertion. Early removal of the implant could be responsible for the higher rates of malunion in this study.

    The authors also reported an increase in the angle of malunion between the immediate postoperative evaluation and that at final follow up. This finding also could be attributable to early implant removal. In addition, the authors do not report when they allowed patients to begin weight bearing in the two groups; early weight bearing could contribute to these problems.

    Finally, the authors favor the use of stainless steel over titanium elastic nails but do not compare the average time of fracture union or any other significant differences between the groups.

    The authors did not receive any outside funding or grants in support of their research for or preparation of this work. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.

    References

    1.Wall EJ, Jain V, Vora V, Mehlman CT, Crawford AH. Complications of titanium and stainless steel elastic nail fixation of pediatric femoral fractures. J Bone Joint Surg Am 2008; 90(6):1305-13.

    2.Flynn JM, Luedtke LM, Ganley TJ, Dawson J, Davidson RS, Dormans JP, Ecker ML, Gregg JR, Horn BD, Drummond DS. Comparison of titanium elastic nails with traction and a spica cast to treat femoral fractures in children. J Bone Joint Surg Am 2004; 86(4):770-7.

    3.Ho CA, Skaggs DL, Tang CW, Kay RM. Use of flexible intramedullary nails in pediatric femur fractures. J Pediatr Orthop 2006; 26(4):497-504.

    4.Heybeli M, Muratli HH, Celebi L, Gülçek S, Bicimoglu A.The results of intramedullary fixation with titanium elastic nails in children with femoral fractures. Acta Orthop Traumatol Turc 2004; 38(3):178-87.

    5.Luhmann SJ, Schootman M, Schoenecker PL, Dobbs MB, Gordon JE. Complications of titanium elastic nails for pediatric femoral shaft fractures. J Pediatr Orthop 2003; 23(4):443-7.

    6.Ligier JN, Metaizeau JP, Prevot J, Lascombes P. Elastic stable intramedullary nailing of femoral shaft fractures in children. J Bone Joint Surg Br 1988; 70(1):74-7.

    7.Flynn JM, Hresko T, Reynolds RA, Blasier RD, Davidson R, Kasser J. Titanium elastic nails for pediatric femur fractures: a multicenter study of early results with analysis of complications. J Pediatr Orthop 2001; 21(1):4-8.

    8.Narayanan UG, Hyman JE, Wainwright AM, Rang M, Alman BA. Complications of elastic stable intramedullary nail fixation of pediatric femoral fractures, and how to avoid them. J Pediatr Orthop 2004; 24(4):363 -9.

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