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

2026년 8월 26일 업데이트: Yu Zhang, PhD

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

72

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Yu Zhang,Director of Department of Orthopedic Oncology
  • 전화번호: +8613602744495
  • 이메일: luck_2001@126.com

연구 장소

  • 중국
    • Guangdong
      • Guangzhou, Guangdong, 중국, 510080
        • Guangdong Provincial People's Hospital
        • 연락하다:
          • Yu Zhang,Director of Department of Orthopedic Oncology
          • 전화번호: +8613602744495
          • 이메일: luck_2001@126.com

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Magnesium-containing degradable polymer bone repair material implantation
Patients receive implantation of magnesium-containing degradable polymer bone repair material for bone defect repair
장치: Magnesium-containing degradable polymer bone repair material
Implanted magnesium-containing degradable polymer bone repair material for bone defect reconstruction
활성 비교기: Control group: Conventional bone repair material implantation
Patients receive implantation of conventional bone repair material for bone defect repair
장치: Conventional non-magnesium bone repair material
Implanted conventional non-magnesium bone repair material for bone defect reconstruction

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Total cumulative dose of tramadol within 12-week post-operation
기간: 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
12 weeks after surgical implantation

2차 결과 측정

결과 측정
측정값 설명
기간
Surgical site infection (SSI) rate
기간: 12 weeks after surgical implantation
Proportion of participants presenting surgical site infection within 12-week post-operation, assessed by clinical signs and laboratory examinations.
12 weeks after surgical implantation
Local tumor recurrence rate
기간: 24 weeks after surgical implantation
Proportion of participants with local tumor recurrence confirmed by imaging examination.
24 weeks after surgical implantation
New bone volume assessed by CT three-dimensional reconstruction
기간: 24 weeks after surgical implantation
Quantitative new bone volume within bone defect area measured by postoperative CT three-dimensional reconstruction.
24 weeks after surgical implantation

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Yu Zhang, PhD

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 12월 31일

연구 완료 (추정된)

2028년 6월 1일

연구 등록 날짜

최초 제출

2026년 8월 26일

QC 기준을 충족하는 최초 제출

2026년 8월 26일

처음 게시됨 (실제)

2026년 8월 31일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 31일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 26일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • KY2026-618-02

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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