Clinical Efficacy Study of Magnesium-Containing Degradable Polymer Bone Repair Material for Bone-Defect Repair After Extremity Bone Tumor Resection (MAGBONE)
Clinical Study on the Efficacy of Magnesium-Containing Degradable Polymer Bone Repair Material for Repairing Bone Defects 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.
Przegląd badań
Status
Szczegółowy opis
This investigator-initiated single-center prospective randomized open-label non-inferiority trial plans to recruit 72 adult subjects with bone defects following extremity bone tumor or tumor-like lesion resection. Randomization will be stratified by upper-limb versus lower-limb defect location to balance mechanical load confounding between groups, with 36 subjects allocated to each arm.
After standard tumor resection, the experimental group receives implantation of magnesium-containing degradable polymer bone repair material. The control group uses commercially available conventional bone repair material without magnesium. Post-operative standardized care protocols including antibiotic prophylaxis, stepwise analgesia regimen, wound dressing and weight-bearing rehabilitation are identical for both groups. Opioid consumption will be converted to morphine-equivalent dose for primary endpoint analysis, with a pre-specified non-inferiority margin of 9.726 mg morphine equivalent. At 1-, 3- and 6-month follow-ups, thin-slice CT scans are performed for quantitative 3D reconstruction to assess new bone formation volume. Two independent radiology reviewers blinded to group assignment conduct volumetric measurement to reduce assessment bias. Surgical-site infection is defined by combined clinical manifestation, laboratory tests and bacterial culture results. Local tumor recurrence is confirmed by imaging or pathological biopsy. Safety assessments cover material-related adverse reactions, implant-associated complications and surgery-related adverse events.Statistical analyses will test non-inferiority for the primary endpoint. Continuous secondary outcomes will be analyzed using t-test or rank-sum test; categorical variables will adopt Chi-square test or Fisher's exact test. Subgroup analyses for upper-limb and lower-limb subgroups will be performed. Both full-analysis set and per-protocol set will be used for efficacy assessment. This trial follows the Declaration of Helsinki and has obtained institutional ethics committee approval. Written informed consent will be obtained from each participant before enrolment.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Yu Zhang,Director of Department of Orthopedic Oncology
- Numer telefonu: +8613602744495
- E-mail: luck_2001@126.com
Lokalizacje studiów
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Guangdong
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Guangzhou, Guangdong, Chiny, 510080
- Guangdong Provincial People's Hospital
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Kontakt:
- Yu Zhang,Director of Department of Orthopedic Oncology
- Numer telefonu: +8613602744495
- E-mail: luck_2001@126.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Magnesium-containing degradable polymer bone repair material implantation
Patients receive implantation of magnesium-containing degradable polymer bone repair material for bone defect repair
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Implanted magnesium-containing degradable polymer bone repair material for bone defect reconstruction
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Aktywny komparator: Control group: Conventional bone repair material implantation
Patients receive implantation of conventional bone repair material for bone defect repair
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Implanted conventional non-magnesium bone repair material for bone defect reconstruction
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Total cumulative dose of tramadol within 12-week post-operation
Ramy czasowe: 12 weeks after surgical implantation
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Total cumulative dosage of tramadol (mg) used for postoperative pain control within 12 weeks after surgical implantation of bone repair material
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12 weeks after surgical implantation
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Surgical site infection (SSI) rate
Ramy czasowe: 12 weeks after surgical implantation
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Proportion of participants presenting surgical site infection within 12-week post-operation, assessed by clinical signs and laboratory examinations.
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12 weeks after surgical implantation
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Local tumor recurrence rate
Ramy czasowe: 24 weeks after surgical implantation
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Proportion of participants with local tumor recurrence confirmed by imaging examination.
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24 weeks after surgical implantation
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New bone volume assessed by CT three-dimensional reconstruction
Ramy czasowe: 24 weeks after surgical implantation
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Quantitative new bone volume within bone defect area measured by postoperative CT three-dimensional reconstruction.
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24 weeks after surgical implantation
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- KY2026-618-02
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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