Orthopedics

Letters 

Early Postoperative Failure of a New Intramedullary Fixation Device for Midshaft Clavicle Fractures

Mark Ayoub, MD; Christopher Doumas, MD

Abstract

Dr Ayoub has no relevant financial relationships to disclose.

Dr Doumas is an educational lecturer for Sonoma.

Click here to read this article.

We read with interest the article “Early Postoperative Failure of a New Intramedullary Fixation Device for Midshaft Clavicle Fractures,”1 which appeared in the November 2013 issue of Orthopedics. As stated on the Sonoma CRx technique guide for intramedullary nailing of midshaft clavicle fractures, “The only requirements are that the implant extends a minimum of 50 mm beyond the most medial edge of the fracture and 20 mm beyond the most lateral edge of the fracture to ensure bone support.”2

Based on the radiographs provided in the article by Wilson et al,1 it would appear then that improper placement of the implant has to be strongly considered as a cause of failure for at least 1 of the 2 case reports. Although the exact dimensions are not provided in these images, based on the described shortening (28 mm) for patient 1 (Figure 1 in the article), the first implant appears to extend less than 50 mm past the medial border of the fracture, contrary to the described requirements of the Sonoma implant. No information is given regarding whether patient 2 had risk factors for nonunion (eg, smoking or diabetes mellitus).

Although this article depicts the potential for failure with intramedullary fixation, it is important to consider that this potential can be significantly reduced by adhering strictly to the guidelines for nail placement, being judicious in its use in more medial midshaft clavicle fracture patterns, and considering antegrade placement from a medial starting point for more medial fractures. Finally, the risk of implant failure is not exclusive to intramedullary nails and also exists for plate fixation (2.51%3 vs 2.34% for intramedullary nails2).

Mark Ayoub, MD

Christopher Doumas, MD

New Brunswick, New Jersey

Dr Ayoub has no relevant financial relationships to disclose.

Dr Doumas is an educational lecturer for Sonoma.

We thank Drs Doumas and Ayoub for their thoughtful comments. Their technique points are well received. Deviations from the described technique for 1 of the cases must be considered. Although neither patient had pertinent additional risk factors for nonunion, the relevance of the described nonunion risk factors (eg, diabetes mellitus or smoking) as they relate to risk for early postoperative hardware failure is not well defined.

These are not the only hardware failures reported for this device. Palmer et al1 reported 2 cases of failure at 2 and 5 months postoperatively, respectively. In orthopedics, there is benefit to describing case failures as well as successes.

Although the 4 reported cases do not define the rate or pattern of failure, risk of failure, or risk of nonunion, they raise questions about construct stability, and further biomechanical study is warranted. In the treatment of middle one-third clavicle fractures, careful scrutiny of surgical indications, adherence to good surgical technique, consideration of patient-specific factors, implant selection, and protocol selection for postoperative advancement to activity are all important components of successful patient outcomes.

CPT David Wilson, MD

CPT DeWayne Weaver, MD

MAJ Todd Balog, MD

COL (ret) Edward Arrington, MD

Tacoma, Washington

Dr Ayoub has no relevant financial relationships to disclose.

Dr Doumas is an educational lecturer for Sonoma.

Click here to read this article.

To the Editor:

We read with interest the article “Early Postoperative Failure of a New Intramedullary Fixation Device for Midshaft Clavicle Fractures,”1 which appeared in the November 2013 issue of Orthopedics. As stated on the Sonoma CRx technique guide for intramedullary nailing of midshaft clavicle fractures, “The only requirements are that the implant extends a minimum of 50 mm beyond the most medial edge of the fracture and 20 mm beyond the most lateral edge of the fracture to ensure bone support.”2

Based on the radiographs provided in the article by Wilson et al,1 it would appear then that improper placement of the implant has to be strongly considered as a cause of failure for at least 1 of the 2 case reports. Although the exact dimensions are not provided in these images, based on the described shortening (28 mm) for patient 1 (Figure 1 in the article), the first implant appears to extend less than 50 mm past the medial border of the fracture, contrary to the described requirements of the Sonoma implant. No information is given regarding whether patient 2 had risk factors for nonunion (eg, smoking or diabetes mellitus).

Although this article depicts the potential for failure with intramedullary fixation, it is important to consider that this potential can be significantly reduced by adhering strictly to the guidelines for nail placement, being judicious in its use in more medial midshaft clavicle fracture patterns, and considering antegrade placement from a medial starting point for more medial fractures. Finally, the risk of implant failure is not exclusive to intramedullary nails and also exists for plate fixation (2.51%3 vs 2.34% for intramedullary nails2).

Mark Ayoub, MD

Christopher Doumas, MD

New Brunswick, New Jersey

References

  1. Wilson DJ, Weaver DL, Balog TP, Arrington ED. Early postoperative failure of a new intramedullary fixation device for midshaft clavicle fractures. Orthopedics. 2013; 36(11):e1450–e1453. doi:10.3928/01477447-20131021-31 [CrossRef]
  2. Sonoma Orthopedic Products, Inc. http://www.sonomaorthopedics.com. Accessed November 31, 2013.
  3. Wijdicks F-JG, Van der Meijden OAJ, Millett PJ, Verleisdonk EJMM, Houwert RM. Systematic review of the complications of plate fixation of clavicle fractures. Arch Orthop Trauma Surg. 2012; 132:617–625. doi:10.1007/s00402-011-1456-5 [CrossRef]

Reply

Dr Ayoub has no relevant financial relationships to disclose.

Dr Doumas is an educational lecturer for Sonoma.

We thank Drs Doumas and Ayoub for their thoughtful comments. Their technique points are well received. Deviations from the described technique for 1 of the cases must be considered. Although neither patient had pertinent additional risk factors for nonunion, the relevance of the described nonunion risk factors (eg, diabetes mellitus or smoking) as they relate to risk for early postoperative hardware failure is not well defined.

These are not the only hardware failures reported for this device. Palmer et al1 reported 2 cases of failure at 2 and 5 months postoperatively, respectively. In orthopedics, there is benefit to describing case failures as well as successes.

Although the 4 reported cases do not define the rate or pattern of failure, risk of failure, or risk of nonunion, they raise questions about construct stability, and further biomechanical study is warranted. In the treatment of middle one-third clavicle fractures, careful scrutiny of surgical indications, adherence to good surgical technique, consideration of patient-specific factors, implant selection, and protocol selection for postoperative advancement to activity are all important components of successful patient outcomes.

CPT David Wilson, MD

CPT DeWayne Weaver, MD

MAJ Todd Balog, MD

COL (ret) Edward Arrington, MD

Tacoma, Washington

Reference

  1. Palmer DK, Husain A, Phipatanakul WP, Wongworawat MD. Failure of a new intramedullary device in fixation of clavicle fractures: a report of two cases and review of the literature. J Shoulder Elbow Surg. 2011; 20(4):e1–e4.

10.3928/01477447-20140124-35

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