Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2016-08-31
2018-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PLGA-Mg material
The fixation of fragments of study group was accomplished with PLGA-Mg material.
PLGA-Mg material
The PLGA-Mg material was used to accomplish the fixation of fragments. Then, the clinical outcome was assessed.
titanium alloy
The fixation of fragments of control group was accomplished with titanium alloy material.
titanium alloy
Traditional fixation was titanium alloy. the clinical outcome was assessed.
Interventions
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PLGA-Mg material
The PLGA-Mg material was used to accomplish the fixation of fragments. Then, the clinical outcome was assessed.
titanium alloy
Traditional fixation was titanium alloy. the clinical outcome was assessed.
Eligibility Criteria
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Inclusion Criteria
* Closed fracture
* Sign the agreement of the experiment
Exclusion Criteria
* Open fracture
* Refused to participate
* Follow-up insufficient 12 months
18 Years
65 Years
ALL
Yes
Sponsors
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Hebei Medical University Third Hospital
OTHER
Responsible Party
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Principal Investigators
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Ruipeng Zhang, M.D
Role: PRINCIPAL_INVESTIGATOR
Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
Locations
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Hebei Medical University Third Hospital
Shijiazhuang, Hebei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZYZ2017
Identifier Type: -
Identifier Source: org_study_id
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