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

Phase 2RecruitingNCT05595603

Second Affiliated Hospital, School of Medicine, Zhejiang University153 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

153

Conditions

Giant Cell Tumor of Bone

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

time to first local recurrence

Time to first local recurrence will be reported during postoperative 18-month follow up period

Time frame: All patients will be followed for this endpoint until 18 months postoperatively

Secondary Outcomes

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

Time frame: Doctors will be responsible in filling this questionnaire 3 months, 9 months, 12 months, 18 months postoperatively during patients' follow up

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

Time frame: 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

Time frame: 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

Time frame: Patients will be followed to report any complication 1 month, 3 months, 6 months, 9 months, 12 months, 18 months postoperatively.