Clinical Efficacy Study of Magnesium-Containing Degradable Polymer Bone Repair Material for Bone-Defect Repair After Extremity Bone Tumor Resection

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.

Inclusion Criteria: * 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. * Voluntarily participate in this study, provide written informed consent, and be judged by investigators to comply with study protocol and complete follow-up visits. * No postoperative local rejection or allergic reaction at the operative site. * Diameter of bone defect ≤ 6 cm, and product usage volume ≤ 77 cm³. * Bone defect located in upper extremity (humerus, ulna-radius, carpal bones) or lower extremity (femur, tibia, fibula, ankle, foot bones). Exclusion Criteria: * 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. * Pregnant or lactating women. * Expected survival less than 12 months, or unable to complete at least 12-month follow-up. * Known or suspected allergy to collagen, hydroxyapatite or other components of bone repair materials. * Occurrence of local rejection or allergic reaction at operative site after surgery. * Diameter of bone defect \> 6 cm, or product usage volume \> 77 cm³. * Any other conditions judged by investigators making the subject unsuitable for enrollment.