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What Factors Are Associated With Implant Breakage and Revision After Intramedullary Nailing for Femoral Metastases?

Willeumier, Julie J., MD; Kaynak, Mustafa, MD; van der Zwaal, Peer, MD, PhD; Meylaerts, Sven A. G., MD, PhD; Mathijssen, Nina M. C., PhD; Jutte, Paul C., MD, PhD; Tsagozis, Panagiotis, MD, PhD; Wedin, Rikard, MD, PhD; van de Sande, Michiel A. J., MD, PhD; Fiocco, Marta, PhD; Dijkstra, P. D. Sander, MD, PhD

Clinical Orthopaedics and Related Research®: September 2018 - Volume 476 - Issue 9 - p 1823–1833
doi: 10.1007/s11999.0000000000000201
2017 INTERNATIONAL SOCIETY OF LIMB SALVAGE PROCEEDINGS
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Background Actual and impending pathologic fractures of the femur are commonly treated with intramedullary nails because they provide immediate stabilization with a minimally invasive procedure and enable direct weightbearing. However, complications and revision surgery are prevalent, and despite common use, there is limited evidence identifying those factors that are associated with complications.

Questions/purposes Among patients treated with intramedullary nailing for femoral metastases, we asked the following questions: (1) What is the cumulative incidence of local complications? (2) What is the cumulative incidence of implant breakage and what factors are associated with implant breakage? (3) What is the cumulative incidence of revision surgery and what factors are associated with revision surgery?

Methods Between January 2000 and December 2015, 245 patients in five centers were treated with intramedullary nails for actual and impending pathologic fractures of the femur caused by bone metastases. During that period, the general indications for intramedullary nailing of femoral metastases were impending fractures of the trochanter region and shaft and actual fractures of the trochanter region if sufficient bone stock remained; nails were used for lesions of the femoral shaft if they were large or if multiple lesions were present. Of those treated with intramedullary nails, 51% (117) were actual fractures and 49% (111) were impending fractures. A total of 60% (128) of this group were women; the mean age was 65 years (range, 29-93 years). After radiologic followup (at 4-8 weeks) with the orthopaedic surgeon, because of the palliative nature of these treatments, subsequent in-person followup was performed by the primary care provider on an as-needed basis (that is, as desired by the patient, without any scheduled visits with the orthopaedic surgeon) throughout each patient’s remaining lifetime. However, there was close collaboration between the primary care providers and the orthopaedic team such that orthopaedic complications would be reported. A total of 67% (142 of 212) of the patients died before 1 year, and followup ranged from 0.1 to 175 months (mean, 14.4 months). Competing risk models were used to estimate the cumulative incidence of local complications (including persisting pain, tumor progression, and implant breakage), implant breakage separately, and revision surgery (defined as any reoperation involving the implant other than débridement with implant retention for infection). A cause-specific multivariate Cox regression model was used to estimate the association of factors (fracture type/preoperative radiotherapy and fracture type/use of cement) with implant breakage and revision, respectively.

Results Local complications occurred in 12% (28 of 228) of the patients and 6-month cumulative incidence was 8% (95% confidence interval [CI], 4.7-11.9). Implant breakage occurred in 8% (18 of 228) of the patients and 6-month cumulative incidence was 4% (95% CI, 1.4-6.5). Independent factors associated with increased risk of implant breakage were an actual (as opposed to impending) fracture (cause-specific hazard ratio [HR_cs], 3.61; 95% CI, 1.23-10.53, p = 0.019) and previous radiotherapy (HR_cs, 2.97; 95% CI, 1.13-7.82, p = 0.027). Revisions occurred in 5% (12 of 228) of the patients and 6-month cumulative incidence was 2.2% (95% CI, 0.3-4.1). The presence of an actual fracture was independently associated with a higher risk of revision (HR_cs, 4.17; 95% CI, 0.08-0.82, p = 0.022), and use of cement was independently associated with a lower risk of revision (HR_cs, 0.25; 95% CI, 1.20-14.53, p = 0.025).

Conclusions The cumulative incidence of local complications, implant breakage, and revisions is low, mostly as a result of the short survival of patients. Based on these results, surgeons should consider use of cement in patients with intramedullary nails with actual fractures and closer followup of patients after actual fractures and preoperative radiotherapy. Future, prospective studies should further analyze the effects of adjuvant therapies and surgery-related factors on the risk of implant breakage and revisions.

Level of Evidence Level III, therapeutic study.

J. J. Willeumier, M. Kaynak, M. A. J. van de Sande, P. D. S. Dijkstra, Department of Orthopaedic Surgery, Leiden University Medical Centre, Leiden, The Netherlands

P. van der Zwaal, S.A.G. Meylaerts, Department of Surgery, Haaglanden Medisch Centrum, The Hague, The Netherlands

N. M. C. Mathijssen, Department of Orthopaedic Surgery, Reinier de Graaf Gasthuis, Delft, The Netherlands

P. C. Jutte, Department of Orthopaedic Surgery, University Medical Center Groningen, Groningen, The Netherlands

P. Tsagozis, R. Wedin, Section of Orthopaedics and Sports Medicine, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden

M. Fiocco, Mathematical Institute, Leiden University, Leiden, The Netherlands; and the Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, The Netherlands

J. J. Willeumier, Department of Orthopaedic Surgery, Leiden University Medical Centre, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands, email: j.j.willeumier@lumc.nl

One of the authors (JJW) received funding from KWF Kankerbestrijding (UL2013-6286).

All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request.

Clinical Orthopaedics and Related Research® neither advocates nor endorses the use of any treatment, drug, or device. Readers are encouraged to always seek additional information, including FDA-approval status, of any drug or device prior to clinical use.

Each author certifies that his or her institution approved the human protocol for this investigation and that all investigations were conducted in conformity with ethical principles of research.

This work was performed at Leiden University Medical Center, Leiden, The Netherlands.

Received August 11, 2017

Received in revised form December 19, 2017

Accepted January 08, 2018

© 2018 Lippincott Williams & Wilkins LWW
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