This is a single-center prospective randomized open-label non-inferiority clinical trial for adult patients with bone defects after extremity bone tumor resection. This study aims to evaluate the analgesic effect, osteogenic capacity and safety of magnesium-containing degradable polymer bone repair material.
Up to 72 eligible patients aged 18-75 years will be enrolled and randomly divided into two groups at a 1:1 ratio. Patients in the experimental group will receive magnesium-containing degradable polymer bone repair material to fill bone defects after tumor removal. Patients in the control group will be implanted with conventional magnesium-free bone repair material. All participants will receive unified surgical anti-infection treatment, pain control, wound management and postoperative rehabilitation.The main study goal is to test whether the pain-relieving effect of the magnesium-containing material is not worse than conventional bone repair material. We will calculate total opioid pain-killer medicine consumption within 3 days, 7 days and 1 month after surgery. Secondary observations include newly-formed bone volume measured by CT three-dimensional reconstruction, surgical site infection rate and local tumor recurrence rate. Patients will complete scheduled follow-up visits at 1-month, 3-month and 6-month after surgery. All unexpected health problems or adverse reactions will be recorded during follow-up.
Subjects with bone tumors (benign or borderline) or tumor-like bone lesions of extremities confirmed by imaging and/or pathology, scheduled for surgical resection.
Bone defects formed after resection of extremity bone tumor, requiring artificial bone repair material for defect filling and reconstruction.
Age from 18 to 75 years old, regardless of gender.
Good general preoperative condition and able to tolerate surgical treatment.
Active local infection at operative site or severe systemic infection.
Severe bone metabolic diseases that may interfere with bone healing, such as severe osteoporosis or uncontrolled hyperparathyroidism.
Severe cardiac, hepatic, renal insufficiency or other serious systemic diseases which cannot tolerate surgery or interfere with study evaluation.
Severe hematological or immune system disorders.
Parallel
Magnesium-containing degradable polymer bone repair material
DeviceImplanted magnesium-containing degradable polymer bone repair material for bone defect reconstruction
Conventional non-magnesium bone repair material
DeviceImplanted conventional non-magnesium bone repair material for bone defect reconstruction
Total cumulative dose of tramadol within 12-week post-operation
Total cumulative dosage of tramadol (mg) used for postoperative pain control within 12 weeks after surgical implantation of bone repair material
Surgical site infection (SSI) rate
Proportion of participants presenting surgical site infection within 12-week post-operation, assessed by clinical signs and laboratory examinations.
Local tumor recurrence rate
Proportion of participants with local tumor recurrence confirmed by imaging examination.
New bone volume assessed by CT three-dimensional reconstruction
Quantitative new bone volume within bone defect area measured by postoperative CT three-dimensional reconstruction.
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Yu Zhang, PhD
Lead sponsor
Guangdong Provincial People's Hospital
Sponsor institution
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