Bioactive glass granules versus standard autologous and allogeneic bone grafts: a randomized trial of 49 adult bone tumor patients with a 10-year follow-up

Hannu T Aro; Ville-Valtteri Välimäki; Niko Strandberg; Petteri Lankinen; Eliisa Löyttyniemi; Virva Saunavaara; Marko Seppänen

doi:10.2340/17453674.2022.2808

Authors

Hannu T Aro Department of Orthopaedic Surgery and Traumatology, Turku University Hospital and University of Turku, Turku https://orcid.org/0000-0003-3118-9144
Ville-Valtteri Välimäki Department of Orthopaedic Surgery and Traumatology, Turku University Hospital and University of Turku, Turku
Niko Strandberg Department of Orthopaedic Surgery and Traumatology, Turku University Hospital and University of Turku, Turku
Petteri Lankinen Department of Orthopaedic Surgery and Traumatology, Turku University Hospital and University of Turku, Turku
Eliisa Löyttyniemi Unit of Biostatistics, Department of Clinical Medicine, University of Turku, Turku
Virva Saunavaara Turku PET Center, University of Turku and Turku University Hospital, and Department of Medical Physics, Division of Medical Imaging, Turku University Hospital, Turku https://orcid.org/0000-0001-7858-5924
Marko Seppänen Department of Clinical Physiology, Nuclear Medicine and Turku PET Centre, University of Turku and Turku University Hospital, Turku, Finland

DOI:

https://doi.org/10.2340/17453674.2022.2808

Keywords:

Bone graft, Bone tumours, Nuclear medicine, RCT

Abstract

Background and purpose: As a synthetic bone void filler, bioactive glasses (BGs) may enhance angiogenesis and osteogenesis. In this randomized trial, we compared the clinical efficacy of BG granules and standard bone grafts in patients undergoing surgery for benign bone tumors.
Patients and methods: 49 recruited patients were randomized to receive BG granules or undergo conventional bone grafting to fill defects following tumor removal. As the standard of care, small-sized defects were filled with autologous graft, and large-sized defects were filled with allogeneic graft. The primary endpoint was treatment success at 1 year, defined by no reoperation, no tumor recurrence, and no device-related adverse events. Secondary endpoints included patient-reported outcomes (Rand-36 and pain scores) and quantitative assessment of blood flow and metabolic activity by means of 18F-fluoride PET/CT imaging. As an off-trial group, 15 children and adolescents (age < 18 years) underwent tumor removal and BG-filling, without randomization.
Results: At 1-year, 21 of 25 BG-treated patients (risk estimate 0.84, 95% confidence interval [CI] 0.70–0.98) and 20 of 24 patients in the standard of care group (0.83, CI 0.68–0.98) met the criteria for treatment success. The groups had similar Rand-36 scores. In patients with small defects, BG filling was associated with shorter operative time and less postoperative pain at 1 month. In patients with large defects, blood flow was similar, but BG-filled defects showed higher metabolic activity than allograft-filled defects at 1-year. The survey of the postoperative period ≥10 years revealed no BG-related adverse events.
Interpretation: BG granules had similar overall rates of treatment success compared with autografts and allografts, but large-scale trials are needed for the confirmation of clinical equivalence. The extended metabolic activity confirms the expected cellular responses of osseointegrated BG granules.