RecruitingPhase 2NCT05595603

Zoledronic Acid-loaded Bone Cement as a Local Adjuvant Therapy for Giant Cell Bone Tumor After Intralesional Curettage

Zoledronic Acid-loaded Bone Cement as a Local Adjuvant Therapy for Giant Cell Bone Tumor After Intralesional Curettage: a Prospective, Multicenter, Single Blinded, Randomized Control Trial.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

153 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Giant Cell Tumor of Bone

Summary

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 ).

Eligibility

Inclusion Criteria5

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
sign the informed consent form

Exclusion Criteria9

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
patient can not conduct self-assessment during follow up
difficulty in complete postoperative follow-up
previous use of bisphosphonate/ZOL or denosumab drug
patients have participated in similar research projects
refused to sign informed consent

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Interventions

PROCEDURE4mg ZOL loaded gentamicin PMMA

During 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.

PROCEDUREgentamicin PMMA

During 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.