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Joint Diseases and
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Original Article · Open access

Safety and feasibility of calcium sulfate/hydroxyapatite with zoledronic acid for the augmentation of helical blades in trochanteric fractures: A randomized pilot study

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Hakan Yolaçan

Department of Orthopedics and Traumatology, Aksaray University Faculty of Medicine, Aksaray, Türkiye

ORCID: 0000-0002-2449-9745

Deepak Bushan Raina

Department of Orthopaedics, Lund University, Clinical Sciences Lund, Lund, Sweden

ORCID: 0000-0001-8767-892X

Lars Lidgren

Department of Orthopaedics, Lund University, Clinical Sciences Lund, Lund, Sweden

ORCID: 0000-0002-5204-1029

Magnus Tägil

Department of Orthopaedics, Lund University, Clinical Sciences Lund, Lund, Sweden

ORCID: 0000-0002-0783-5591

Šarūnas Tarasevičius

Department of Orthopedics and Traumatology, Lithuanian University of Health Sciences, Kaunas, Lithuania

ORCID: 0000-0002-8625-8648

Serkan Güler

Department of Orthopedics and Traumatology, Aksaray University Faculty of Medicine, Aksaray, Türkiye

ORCID: 0000-0002-3424-4244

Tolga Tolunay

Department of Orthopedics and Traumatology, Gazi University Faculty of Medicine, Ankara, Türkiye Ankara Medipol University, Ankara, Türkiye

ORCID: 0000-0003-1998-3695

Vetra Markevičiūtė

Department of Orthopedics and Traumatology, Lithuanian University of Health Sciences, Kaunas, Lithuania

ORCID: 0000-0003-1009-5042

Erdem Aras Sezgin

Department of Orthopedics and Traumatology, Aksaray University Faculty of Medicine, Aksaray, Türkiye Department of Orthopedics and Traumatology, Gazi University Faculty of Medicine, Ankara, Türkiye

ORCID: 0000-0001-5869-6571

Abstract

Objectives: This study aims to evaluate the feasibility, safety, and periimplant bone formation of augmenting a proximal femoral nail (PFN) helical blade with a calcium sulfate/hydroxyapatite (CaS/HA) biomaterial combined with systemic zoledronic acid (ZA).

Patients and methods: This single-center, two-arm, parallel-group, randomized-controlled pilot study included a total of 20 patients with osteoporotic trochanteric fractures (TFs) between December 2023 and January 2025. The patients were randomized into a control group receiving standard PFN or an intervention group receiving PFN augmented with CaS/HA biomaterial. All patients received cefazoline and doxycycline for infection prophylaxis. On postoperative Day 7, both groups received a single intravenous infusion of ZA. The primary outcome was the change in bone mineral density (BMD) defined by previously published peri-implant regions-of-interest at one week and six months postoperatively. Secondary outcomes included tip-apex distance (TAD) for assessing blade migration and the Harris Hip Score (HHS) for functional evaluation.

Results: Of a total of 20 patients included in the study, 6 were male and 14 were female with a median age of 81 (range, 65 to 90) years. Regarding intervention delivery, all 10 randomly assigned patients received their intended treatment. While 19 of the 20 randomly assigned patients received the intended treatment; one patient died within the first week and did not receive ZA. The required data for clinical analysis (change in peri-implant BMD, TAD, fracture union, and HHS) could only be extracted for five patients in the control group and five patients in the intervention group. There were no intraoperative complications, and no adverse effects related to the CaS/HA biomaterial were reported. Ten patients were included for the outcome analysis. The intervention group demonstrated a more pronounced increase in peri-implant BMD compared to controls. Additionally, TAD changed more in the control group. Functional evaluation revealed that the intervention group demonstrated a slightly greater HHS improvement.

Conclusion: Our study results suggest that augmentation using the CaS/HA and ZA is a feasible and safe procedure for patients with osteoporotic TF. Preliminary findings indicate a potential trend toward enhanced peri-implant bone formation in the intervention group.

Declarations

Author Contributions

D.B.R., L.L., V.T., E.A.S.: Idea/ concept; H.Y., D.B.R, L.L, V.T., E.A.S.: Design; D.B.R., L.L., M.T., T.T., E.A.S.: Control/supervision; H.Y., D.B.R., M.T., S.G., E.A.S.: Data collection and/or processing; H.Y., D.B.R, L.L., S.G, E.A.S.: Analysis and/or interpretation; H.Y., D.B.R, V.T., E.A.S.: Literature review; H.Y., E.A.S.: Writing the article; D.B.R., L.L., M.T., S.T., T.T., V.T.: Critical review; D.B.R., L.L., M.T.: References and fundings; D.B.R., L.L., M.T., T.T., E.A..: Materials; H.Y.: Performing the surgeries.

Conflict of Interest

D.B.R., M.T., and L.L. are co-founders and hold stocks in Moroxite AB, a non-listed company based in Lund, Sweden. Moroxite AB has not had any role in study design, data analysis, or manuscript preparation. The remaining authors declare no conflict of interest.

Financial Disclosure

This research was funded by the Olav Thon Foundation.

Data Sharing Statement

The data that support the findings of this study are available from the corresponding author upon reasonable request.

AI Disclosure

The authors declare that artificial intelligence (AI) tools were not used, or were used solely for language editing, and had no role in data analysis, interpretation, or the formulation of conclusions. All scientific content, data interpretation, and conclusions are the sole responsibility of the authors. The authors further confirm that AI tools were not used to generate, fabricate, or ‘hallucinate’ references, and that all references have been carefully verified for accuracy.

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