Bone DefectBone Tumor of ExtremityBone-Like Tumor Lesion
Investigational drug(s) / intervention(s)
Magnesium-containing degradable polymer bone repair materialConventional non-magnesium bone repair material
Magnesium-containing degradable polymer bone repair material: Implanted magnesium-containing degradable polymer bone repair material for bone defect reconstruction
Conventional non-magnesium bone repair material: Implanted conventional non-magnesium bone repair material for bone defect reconstruction
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Total cumulative dose of tramadol within 12-week post-operation — 12 weeks after surgical implantation Total cumulative dosage of tramadol (mg) used for postoperative pain control within 12 weeks after surgical implantation of bone repair material
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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