Since its development in 1999, the SIGN nail has been used in over 190,000 surgeries spanning 55 countries. To date, however, evaluation of SIGN nail outcomes has been limited to small prospective studies or large retrospective studies using SIGN’s online database. This study uses the experience of a single, independent Cambodian surgical clinic to characterize common complications, provide commentary on ways to reduce the risk of those complications, and determine whether several observed nail fractures were due to metallurgic defects.
Clinic medical records were queried to identify complications in patients with SIGN nails. Data was abstracted including age, sex, mechanism of injury, and latency between injury, primary implantation, and presentation with a complication. Two nails that fractured in vivo were analyzed by light microscopy, scanning electron microscopy, and polarized light microscopy after chemical etching.
Fifty-four complications in 51 patients were identified. The most common complications were non-union (n = 26, 48%), infection (n = 16, 30%), flexion limitation (n = 11, 20%), nail fracture (n = 4, 7%), delayed union (n = 4, 7%), and malunion (n = 4, 7%). Other complications included broken or floating screws. Fractography revealed that two of the fractured nails most likely failed by fatigue followed by fast fracture at the site of non-union. We found no evidence of intrinsic nail defects. We identified multiple inconsistencies between SIGN’s database and independent clinic records.
Non-union and infection were common relative to all complications. Based on radiographic review, risk for non-union and malunion can be minimized by selecting an appropriate nail diameter, using multiple interlocking screws, and employing the correct implant and approach for fracture morphology when using SIGN nails. Nail fractures were unlikely to be caused by metallurgical flaws. Further study is necessary to determine the appropriate management of non-unions based on radiographic and clinical factors.
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The authors would like to thank SIGN Fracture Care International and Dr. Lewis Zirkle for providing data and contextual information for this study.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. For this type of study, formal consent is not required. This article does not contain any studies with animals performed by any of the authors. The Dartmouth Biomedical Engineering Center performed implant analysis pro bono and SIGN allowed use of a subset of its database without charges.
Conflict of interest
The authors declare that they have no conflict of interest.
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Woelber, E., Martin, A., Van Citters, D. et al. Complications in patients with intramedullary nails: a case series from a single Cambodian surgical clinic. International Orthopaedics (SICOT) 43, 433–440 (2019). https://doi.org/10.1007/s00264-018-3966-z
- SIGN nail
- Nail fracture