The purpose of this study is to investigate whether zoledronic acid-loaded bone cement (4mg ZOL+ gentamicin PMMA ) as adjuvant method can decrease local recurrence in patients with giant cell bone tumor following intralesional curettage surgery. The hypothesis is that patients with local administration of zoledronic acid to the bone cement has lower relapse rate compared those with traditional bone cement(gentamicin PMMA ).
patients with primary resectable GCT of bone
lesion amenable to reconstruction (intralesional curettage) defined as having at least one intact column of bone after removal
no previous systemic bisphosphonate or denosumab therapy
with expected longer than 18 months of survival time
patients with recurrent GCT or extensive GCT which is impossible or inappropriate to use curettage surgery due to its "unresectable" nature.
conduct unexpected surgery at other center
the primary goal for surgery is revision
patient conduct en-bloc/wide resection instead of curettage surgery
Parallel
4mg ZOL loaded gentamicin PMMA
Procedure/SurgeryDuring surgery, 4mg ZOL will be mixed with gentamicin (1000mg) PMMA cement (40g) by surgeon under sterile conditions to prepare ZOL loaded bone cement, and then it will be filled into the bony defects of the patient where the lesion has been removed after intralesional curettage.
gentamicin PMMA
Procedure/SurgeryDuring surgery, gentamicin (1000mg) PMMA (40g) was prepared by surgeon under sterile conditions and will be filled into the bony defects of the patient where the lesion has been removed after intralesional curettage.
time to first local recurrence
Time to first local recurrence will be reported during postoperative 18-month follow up period
MSTS score
The Musculoskeletal Tumor Society (MSTS) scoring system is a disease-specific instrument to determine the physical and mental health for patients underwent limb-salvage surgery after tumor resection and is a validated and well-accepted functional scoring system used in orthopaedic oncology research
TESS score
The Toronto Extremity Salvage Score (TESS) is a physical disability measure developed specifically for patients undergoing surgery for extremity tumours and has been shown to have superior measurement properties compared with other commonly used sc
postoperative complication
Including wound healing problem, mechanical failure, infection and any tumor progression issues
Potential ZOL-related complications
Patients will be followed for atypical bone fractures and avascular necrosis (AVN) of jaw, one of the most severe complication of ZOL
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