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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zoledronic Acid loaded bone cement | Experimental | 4mg zoledronic acid-loaded gentamicin bone cement (PMMA) |
|
| conventional gentamicin bone cement | Active Comparator | gentamicin bone cement (PMMA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4mg ZOL loaded gentamicin PMMA | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| time to first local recurrence | Time to first local recurrence will be reported during postoperative 18-month follow up period | All patients will be followed for this endpoint until 18 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Doctors will be responsible in filling this questionnaire 3 months, 9 months, 12 months, 18 months postoperatively during patients' follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meng Liu, MD | Contact | 13515711791 | liumeng80@163.com | |
| Keyi Wang, MS | Contact | 17398046579 | wky82630965@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University | Recruiting | Hangzhou | 311200 | China |
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|
| gentamicin PMMA | Procedure | 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. |
|
| 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 | Patients will be asked to fill this survey 3 months, 9 months, 12 months, 18 months postoperatively |
| postoperative complication | Including wound healing problem, mechanical failure, infection and any tumor progression issues | Patients will be asked to report any complication 1 month, 3 months, 6 months, 9 months, 12 months, 18 months postoperatively during follow up |
| 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 | Patients will be followed to report any complication 1 month, 3 months, 6 months, 9 months, 12 months, 18 months postoperatively. |
| ID | Term |
|---|---|
| D018212 | Giant Cell Tumor of Bone |
| ID | Term |
|---|---|
| D005870 | Giant Cell Tumors |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018213 | Neoplasms, Bone Tissue |
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| ID | Term |
|---|---|
| C030159 | gentamicin-polymethylmethacrylate bead |
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