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Adverse Reactions of Artificial Bone Graft Substitutes: Lessons Learned From Using Tricalcium Phosphate geneX®

  • Clinical Research
  • Published:
Clinical Orthopaedics and Related Research®

Abstract

Background

Artificial bone graft substitutes are widely used to fill bony defects after curettage of benign tumors. We sought to evaluate the efficacy of one such bone graft substitute, geneX®, which contains tricalcium phosphate and calcium sulphate; however, during the course of this study we observed a high number of complications.

Questions/purposes

The primary aim of this prospective series was assessment of the effectiveness of geneX® concerning resorption profile and bone healing and remodeling after surgery. We present the types and frequencies of complications observed in patients treated for bone tumors by curettage and filling the defect using geneX®.

Methods

We planned to study 40 patients; however, after enrollment of the first 31 patients, the study was stopped as a result of serious complications. There were 20 female and 11 male patients with a mean age at surgery of 40 years (range, 6–71 years). Plain radiographs were obtained at different intervals during followup and CT scans were obtained 6 and 12 months postoperatively. Complications were assessed using a 5-point scale according to Goslings and Gouma.

Results

Five of the 31 patients (16%) had complications develop after surgery. In three cases, a sterile inflammation adjacent to the geneX® occurred, with delayed wound healing in two patients and local pain. In the third patient, geneX® produced moderate to severe skin damage in the area of the scar, needing revision surgery. In two other patients, inflammatory cystic formations developed in the soft tissues with sizes up to 15 cm, which gradually reduced in size with time. Overall, there were four Grade 1 complications and one Grade 2 according to Goslings and Gouma.

Conclusions

We concluded from this series of patients that geneX® causes soft tissue inflammation and pain with its use. Based on this experience we believe that this type of bone substitute should not be used in the treatment of bony defects.

Level of Evidence

Level IV, therapeutic study. See the Instructions for Authors for a complete description of levels of evidence.

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Authors and Affiliations

  1. Department of Orthopaedic Surgery, Medical University of Graz, Graz, Styria, 8036, Austria

    Joerg Friesenbichler MD, Werner Maurer-Ertl MD, Patrick Sadoghi MD, Ulrike Pirker-Fruehauf MD & Andreas Leithner MD

  2. Institute of Pathology, Medical University of Graz, Graz, Austria

    Koppany Bodo MD

Authors
  1. Joerg Friesenbichler MD
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  2. Werner Maurer-Ertl MD
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  3. Patrick Sadoghi MD
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  4. Ulrike Pirker-Fruehauf MD
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  5. Koppany Bodo MD
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  6. Andreas Leithner MD
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Corresponding author

Correspondence to Patrick Sadoghi MD.

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Each author certifies that he or she, or a member of his or her immediate family, has no funding or commercial associations (eg, consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted article.

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 reporting of this case report, that all investigations were conducted in conformity with ethical principles of research, and that informed consent for participation in the study was obtained.

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Friesenbichler, J., Maurer-Ertl, W., Sadoghi, P. et al. Adverse Reactions of Artificial Bone Graft Substitutes: Lessons Learned From Using Tricalcium Phosphate geneX® . Clin Orthop Relat Res 472, 976–982 (2014). https://doi.org/10.1007/s11999-013-3305-z

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  • DOI: https://doi.org/10.1007/s11999-013-3305-z

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