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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.
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 ).
The purpose of the clinical study is to investigate whether the local delivery of zoledronic acid (4mg ZOL-loaded gentamicin PMMA bone cement) as a surgical adjuvant can decrease the local recurrence rate of giant cell tumor (GCT) of bone. The investigators will also evaluate whether patients with zoledronic acid as a surgical adjuvant improves secondary outcomes, including function (MSTS and TESS), surgery related complications (henderson's failure mode) and ZOL-related complications.
Age
All ages
Sex
ALL
Healthy Volunteers
No
The Second Affiliated Hospital of Zhejiang University
Hangzhou, China
Start Date
March 1, 2023
Primary Completion Date
June 1, 2026
Completion Date
December 1, 2026
Last Updated
March 15, 2023
153
ESTIMATED participants
4mg ZOL loaded gentamicin PMMA
PROCEDURE
gentamicin PMMA
PROCEDURE
Lead Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
NCT06647901
NCT03449108
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