Study of PLGA-Mg Material in Clinical Orthopedics
Randomized, Double Blind Trial of Study of PLGA-Mg Material in Clinical Orthopedics
연구 개요
상세 설명
The deposition of calcium could be facilitated by the increase of magnesium, which played an important role in fracture union. However, its degradation may be completed before the fracture line was disappeared. In addition, the hydrogen may be released during degradation. Thus, its clinical popularization was limited.
As a new polymer material, poly lactic-co-glycolic acid (PLGA) has been widely used clinically. The hydrolytic production of PLGA was acidic, which could neutralize the alkalinity of production degraded from magnesium. In addition, it was a long time before the total accomplishment of degradation of PLGA, which may postpone the degradation of magnesium.
The different proportion samples of PLGA-Mg were made in this study. Their physical and chemical properties were analyzed to estimate its safety of implantation. Then, they would be placed in the femoral condyle of the New Zealand rabbits. The osteogenesis and complication of samples are examined to select an appropriate proportion of PLGA-Mg is obtained. Then, the PLGA-Mg material will be used to fix the fracture of human as a fixation. The review of the patients will be conducted to assess its clinical role.
연구 유형
등록 (예상)
단계
- 2 단계
연락처 및 위치
연구 장소
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Hebei
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Shijiazhuang, Hebei, 중국, 050051
- 모병
- Hebei medical university third hospital
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연락하다:
- Yingze Zhang, M.D
- 전화번호: +8613313012888
- 이메일: yzzhangdr@126.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 18-65 years old
- Closed fracture
- Sign the agreement of the experiment
Exclusion Criteria:
- Pathologic fracture
- Open fracture
- Refused to participate
- Follow-up insufficient 12 months
공부 계획
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 |
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위약 비교기: PLGA-Mg material
The fixation of fragments of study group was accomplished with PLGA-Mg material.
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The PLGA-Mg material was used to accomplish the fixation of fragments.
Then, the clinical outcome was assessed.
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위약 비교기: titanium alloy
The fixation of fragments of control group was accomplished with titanium alloy material.
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Traditional fixation was titanium alloy.
the clinical outcome was assessed.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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fracture union time
기간: 4 months
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4 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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complication
기간: 1 months
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nonunion, toxicity
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1 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
PLGA-Mg material에 대한 임상 시험
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National Eye Institute (NEI)모병
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Manhattan Beach Orthodontics완전한
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Virender S Sangwan, MBBS, MSUniversity of Sheffield; Wellcome Trust완전한
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Jaakko SinikumpuOulu University Hospital; Bioretec Ltd.완전한
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British University In Egypt완전한
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University of Campinas, BrazilPontificia Universidade Catolica de Sao Paulo완전한