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Function After Injection of Benign Bone Lesions with a Bioceramic

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

Abstract

Background

A novel calcium sulfate–calcium phosphate composite injectable bone graft substitute has been approved by the FDA for filling bone defects in a nonweightbearing application based on preclinical studies. Its utility has not been documented in the literature.

Questions/purposes

We therefore determined postoperative function and complications in patients with benign bone lesions treated with this bioceramic.

Methods

We retrospectively reviewed all 56 patients with benign bone lesions treated with the bioceramic from 2006 to 2008. There were 29 male and 27 female patients with an average age of 17.6 years (range, 4–63 years). They were treated for the following diagnoses: unicameral bone cyst (13), aneurysmal bone cyst (10), nonossifying fibroma (eight), fibrous dysplasia (five), enchondroma (four), chondroblastoma (four), and other (12). We obtained a Musculoskeletal Tumor Society (MSTS) functional evaluation on all patients. The minimum followup was 26 months (average, 42 months; range, 26–57 months).

Results

The average MSTS score was 29 (range, 20–30). Most patients returned to normal function. There were three local recurrences, all of which were treated with repeat injection or curettage. Two patients had postoperative fractures treated in a closed manner. Two patients had wound complications, neither of which required removal of the graft material.

Conclusion

Patients treated with this material reported high MSTS functional scores more than 24 months after operative intervention and experienced low complication rates. We believe the novel bioceramic to be a reasonable treatment option for benign bone lesions.

Level of Evidence

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

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Acknowledgments

We thank Pat Gargano for administrative assistance.

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Correspondence to Steven Gitelis MD.

Additional information

Each author certifies that he (SG), or a member of their immediate family, has or may receive payments or benefits, in any one year, an amount in excess of $10,000, from a commercial entity (Wright Medical Technology, Arlington, TN, USA) related to this work.

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, 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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Fillingham, Y.A., Lenart, B.A. & Gitelis, S. Function After Injection of Benign Bone Lesions with a Bioceramic. Clin Orthop Relat Res 470, 2014–2020 (2012). https://doi.org/10.1007/s11999-012-2251-5

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  • DOI: https://doi.org/10.1007/s11999-012-2251-5

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