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The Journal of Bone and Joint Surgery 83:537 (2001)
© 2001 The Journal of Bone and Joint Surgery, Inc.

Focal Osteolysis at the Junctions of a Modular Stainless-Steel Femoral Intramedullary Nail

Darron M. Jones, MD, J. Lawrence Marsh, MD, James V. Nepola, MD, Joshua J. Jacobs, MD, Anastasia K. Skipor, MS, Robert M. Urban, Jeremy L. Gilbert, PhD and Joseph A. Buckwalter, MD

Investigation performed at the University of Iowa Hospitals and Clinics, Iowa City, Iowa, Rush Arthritis and Orthopaedics Institute, Rush-Presbyterian-St. Luke’s Medical Center, Chicago, Illinois, and Department of Bioengineering and Neuroscience, Syracuse University, Syracuse, New York
Darron M. Jones, MD J. Lawrence Marsh, MD James V. Nepola, MD Joseph A. Buckwalter, MD Department of Orthopaedic Surgery, the University of Iowa College of Medicine, Lower Level, JPP, Iowa City, IA 52242. E-mail address for J.L. Marsh: j-marsh{at}uiowa.edu
Joshua J. Jacobs, MD Anastasia K. Skipor, MS Robert M. Urban Rush Arthritis and Orthopaedics Institute, Rush-Presbyterian-St. Luke’s Medical Center, 1653 West Congress Parkway, Chicago, IL 60612. E-mail address for J.J. Jacobs: jacobs@orth4.pro.rpslmc.edu
Jeremy L. Gilbert, PhD Department of Bioengineering and Neuroscience, Syracuse University, Syracuse, NY 13244
Although none of the authors has received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article, benefits have been or will be received, but are directed solely to a research fund, foundation, educational institution, or other nonprofit organization with which one or more of the authors is associated. Funds were received in total or partial support of the research or clinical study presented in this article. The funding sources were Smith and Nephew Richards, Incorporated; National Institutes of Health/National Institute of Arthritis and Musculoskeletal and Skin Diseases Grant 39310; and Crown Family Chair of Orthopaedic Surgery.

Background:

During routine follow-up of patients treated with a three-piece stainless-steel modular femoral nail, osteolysis and periosteal reaction around the modular junctions of some of the nails were noted on radiographs. The purpose of this study was to evaluate the prevalence, etiology, and clinical relevance of these radiographic findings.

Methods:

Forty-four femoral fractures or nonunions in forty-two patients were treated with a modular stainless-steel femoral intramedullary nail. Seventeen nails were excluded, leaving twenty-seven intramedullary nails in twenty-seven patients for this study. All patients had had a femoral diaphyseal fracture; nineteen had had an acute fracture and eight, a nonunion. These twenty-seven patients returned for radiographs, a physical examination, assessment of functional outcomes, assessment of thigh pain with a visual analog scale, determination of serum chromium levels, and nail removal if desired. A control group of sixteen patients treated with a one-piece stainless-steel femoral intramedullary nail was evaluated with use of the same outcome measures and was compared with the group treated with the modular femoral nail with regard to prevalence of thigh pain and serum chromium levels. Twelve modular femoral nails were removed according to the study protocol. The modular nail junctions were analyzed for corrosion products, and histopathologic analysis of tissue specimens from the femoral canal was performed.

Results:

The twenty-seven patients were seen at a mean of twenty-one months after fracture fixation; twenty-six of the twenty-seven fractures healed. Twenty-three femora had at least one of three types of abnormalitiesæosteolysis, periosteal reaction, or cortical thickeningælocalized to one or both modular junctions. Eighteen patients had severe reactions, defined as osteolysis of 2 mm, cortical thickening of 5 mm, and/or a periosteal reaction (group 1). Nine patients had mild or no reactions (group 2). Serum chromium levels in group 1 (mean, 1.27 ng/mL; range, 0.34 to 3.12 ng/mL) were twice as high as those in group 2 (mean, 0.53 ng/mL; range, 0.12 to 1.26 ng/mL). However, this difference did not reach significance with the numbers available. The differences in serum chromium levels between group 1 and the control group with a one-piece nail (mean, 0.26 ng/mL; range, 0.015 to 1.25 ng/mL) (p < 0.01) and a control group without an implant (mean, 0.05 ng/mL; range, 0.015 to 0.25 ng/mL) (p < 0.01) were significant. The level of thigh pain recorded on the visual analog scale was also significantly different between group 1 and the control group with a one-piece implant (p = 0.03). Retrieved modular nails had signs of fretting corrosion as well as stainless-steel corrosion products adherent to the junction where the osteolysis occurred. Histologic and spectrographic analysis revealed two types of corrosion products that were consistent with stainless-steel within the peri-implant tissue and were associated with a foreign-body granulomatous response.

Conclusions:

The presence of corrosion products at the taper junctions suggests that particulate debris was a major factor in the etiology of the radiographic findings of osteolysis, periosteal reaction, and cortical thickening. Serum chromium levels were substantially elevated in the patients with a modular femoral nail, and such levels may serve as a marker of fretting corrosion of these devices.


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