Study of PLGA-Mg Material in Clinical Orthopedics

Fracture Dislocation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03060655
• Other study ID #: ZYZ2017
• Status: Recruiting
• Phase: Phase 2
• First received: January 18, 2017
• Last updated: February 21, 2017
• Start date: August 2016
• Est. completion date: March 2018

Study information

• Verified date: January 2017
• Source: Hebei Medical University Third Hospital
• Contact: Yingze Zhang, M.D
• Phone: +8613313012888
• Email: yzzhangdr[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dislocations
• Fracture Dislocation

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
China	Hebei Medical University Third Hospital	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fracture union time		4 months
Secondary	complication	nonunion, toxicity	1 months