[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bone-like-tumor-lesion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bone-like-tumor-lesion":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100654012","clinical-efficacy-study-of-magnesium-containing-degradable-polymer-bone-repair-material-for-bone-defect-repair-after-extremity-bone-tumor-resection-100654012",false,"NCT07794202","Clinical Efficacy Study of Magnesium-Containing Degradable Polymer Bone Repair Material for Bone-Defect Repair After Extremity Bone Tumor Resection","Clinical Study on the Efficacy of Magnesium-Containing Degradable Polymer Bone Repair Material for Repairing Bone Defects After Extremity Bone Tumor Resection","MAGBONE","Inclusion Criteria:\n\n* Subjects with bone tumors (benign or borderline) or tumor-like bone lesions of extremities confirmed by imaging and\u002For pathology, scheduled for surgical resection.\n* Bone defects formed after resection of extremity bone tumor, requiring artificial bone repair material for defect filling and reconstruction.\n* Age from 18 to 75 years old, regardless of gender.\n* Good general preoperative condition and able to tolerate surgical treatment.\n* Voluntarily participate in this study, provide written informed consent, and be judged by investigators to comply with study protocol and complete follow-up visits.\n* No postoperative local rejection or allergic reaction at the operative site.\n* Diameter of bone defect ≤ 6 cm, and product usage volume ≤ 77 cm³.\n* Bone defect located in upper extremity (humerus, ulna-radius, carpal bones) or lower extremity (femur, tibia, fibula, ankle, foot bones).\n\nExclusion Criteria:\n\n* Active local infection at operative site or severe systemic infection.\n* Severe bone metabolic diseases that may interfere with bone healing, such as severe osteoporosis or uncontrolled hyperparathyroidism.\n* Severe cardiac, hepatic, renal insufficiency or other serious systemic diseases which cannot tolerate surgery or interfere with study evaluation.\n* Severe hematological or immune system disorders.\n* Pregnant or lactating women.\n* Expected survival less than 12 months, or unable to complete at least 12-month follow-up.\n* Known or suspected allergy to collagen, hydroxyapatite or other components of bone repair materials.\n* Occurrence of local rejection or allergic reaction at operative site after surgery.\n* Diameter of bone defect \\> 6 cm, or product usage volume \\> 77 cm³.\n* Any other conditions judged by investigators making the subject unsuitable for enrollment.","ALL","18 Years","75 Years",{"count":21,"type":22},72,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.\n\nUp 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.",[28,29,30],"Bone Defect","Bone Tumor of Extremity","Bone-Like Tumor Lesion",[32,33,34,35,36],"Magnesium-containing degradable polymer bone repair material","Extremity bone tumor resection","Bone regeneration","Post-operative analgesia","Non-inferiority clinical trial","NOT_YET_RECRUITING","2026-08-26",{"date":40,"type":41},"2026-08-31","ACTUAL",{"date":43,"type":22},"2026-09-01",{"date":45,"type":22},"2028-06",{"name":47,"class":48},"Yu Zhang, PhD","OTHER"]