Study of PLGA-Mg Material in Clinical Orthopedics

Study Overview
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Brief Summary
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The different proportion samples of PLGA-Mg were made in this study. Then, they would be placed in the femoral condyle of the New Zealand rabbits. The appropriate proportion of PLGA-Mg is obtained after the experiment, which will be used to make the plate or screw to fix the fragments. Then, the clinical role for bone will be assessed.

Detailed Description
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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.

Official Title
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Randomized, Double Blind Trial of Study of PLGA-Mg Material in Clinical Orthopedics

Conditions
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Fracture Dislocation

Intervention / Treatment
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* Biological: PLGA-Mg material
* Biological: titanium alloy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: PLGA-Mg material<br>The fixation of fragments of study group was accomplished with PLGA-Mg material. | Biological: PLGA-Mg material<br>* The PLGA-Mg material was used to accomplish the fixation of fragments. Then, the clinical outcome was assessed.<br>|
| Placebo Comparator: titanium alloy<br>The fixation of fragments of control group was accomplished with titanium alloy material. | Biological: titanium alloy<br>* Traditional fixation was titanium alloy. the clinical outcome was assessed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fracture union time |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication | nonunion, toxicity | 1 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PLGA-Mg, fracture, fixation, union