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Trial Title:
Zoledronic Acid-loaded Bone Cement as a Local Adjuvant Therapy for Giant Cell Bone Tumor After Intralesional Curettage
NCT ID:
NCT05595603
Condition:
Giant Cell Tumor of Bone
Conditions: Official terms:
Bone Neoplasms
Giant Cell Tumors
Giant Cell Tumor of Bone
Gentamicins
Polymethyl Methacrylate
Conditions: Keywords:
Zoledronic Acid, intralesional curettage
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
4mg ZOL loaded gentamicin PMMA
Description:
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.
Arm group label:
Zoledronic Acid loaded bone cement
Intervention type:
Procedure
Intervention name:
gentamicin PMMA
Description:
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.
Arm group label:
conventional gentamicin bone cement
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 ).
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Affiliated Hospital of Zhejiang University
Address:
City:
Hangzhou
Zip:
311200
Country:
China
Status:
Recruiting
Contact:
Last name:
Meng Liu
Phone:
13515711791
Email:
liumeng80@163.com
Start date:
March 2023
Completion date:
December 1, 2026
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05595603
