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RECRUITING
NCT05595603
PHASE2

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

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

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 ).

Official title: 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.

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

153

Start Date

2023-03

Completion Date

2026-12-01

Last Updated

2023-03-15

Healthy Volunteers

No

Interventions

PROCEDURE

4mg 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.

PROCEDURE

gentamicin 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.

Locations (1)

The Second Affiliated Hospital of Zhejiang University

Hangzhou, China