- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03060655
Study of PLGA-Mg Material in Clinical Orthopedics
Randomized, Double Blind Trial of Study of PLGA-Mg Material in Clinical Orthopedics
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Yingze Zhang, M.D
- Phone Number: +8613313012888
- Email: yzzhangdr@126.com
Study Locations
-
-
Hebei
-
Shijiazhuang, Hebei, China, 050051
- Recruiting
- Hebei Medical University Third Hospital
-
Contact:
- Yingze Zhang, M.D
- Phone Number: +8613313012888
- Email: yzzhangdr@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: PLGA-Mg material
The fixation of fragments of study group was accomplished with PLGA-Mg material.
|
The PLGA-Mg material was used to accomplish the fixation of fragments.
Then, the clinical outcome was assessed.
|
Placebo Comparator: titanium alloy
The fixation of fragments of control group was accomplished with titanium alloy material.
|
Traditional fixation was titanium alloy.
the clinical outcome was assessed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
fracture union time
Time Frame: 4 months
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complication
Time Frame: 1 months
|
nonunion, toxicity
|
1 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZYZ2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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