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Study of PLGA-Mg Material in Clinical Orthopedics

Primary Purpose

Fracture Dislocation

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
PLGA-Mg material
titanium alloy
Sponsored by
Hebei Medical University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture Dislocation focused on measuring PLGA-Mg, fracture, fixation, union

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hebei Medical University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Placebo Comparator

Arm Label

PLGA-Mg material

titanium alloy

Arm Description

The fixation of fragments of study group was accomplished with PLGA-Mg material.

The fixation of fragments of control group was accomplished with titanium alloy material.

Outcomes

Primary Outcome Measures

fracture union time

Secondary Outcome Measures

complication
nonunion, toxicity

Full Information

First Posted
January 18, 2017
Last Updated
February 21, 2017
Sponsor
Hebei Medical University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03060655
Brief Title
Study of PLGA-Mg Material in Clinical Orthopedics
Official Title
Randomized, Double Blind Trial of Study of PLGA-Mg Material in Clinical Orthopedics
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Medical University Third Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture Dislocation
Keywords
PLGA-Mg, fracture, fixation, union

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PLGA-Mg material
Arm Type
Placebo Comparator
Arm Description
The fixation of fragments of study group was accomplished with PLGA-Mg material.
Arm Title
titanium alloy
Arm Type
Placebo Comparator
Arm Description
The fixation of fragments of control group was accomplished with titanium alloy material.
Intervention Type
Biological
Intervention Name(s)
PLGA-Mg material
Intervention Description
The PLGA-Mg material was used to accomplish the fixation of fragments. Then, the clinical outcome was assessed.
Intervention Type
Biological
Intervention Name(s)
titanium alloy
Intervention Description
Traditional fixation was titanium alloy. the clinical outcome was assessed.
Primary Outcome Measure Information:
Title
fracture union time
Time Frame
4 months
Secondary Outcome Measure Information:
Title
complication
Description
nonunion, toxicity
Time Frame
1 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingze Zhang, M.D
Phone
+8613313012888
Email
yzzhangdr@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruipeng Zhang, M.D
Organizational Affiliation
Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hebei Medical University Third Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingze Zhang, M.D
Phone
+8613313012888
Email
yzzhangdr@126.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Study of PLGA-Mg Material in Clinical Orthopedics

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