Study of PLGA-Mg Material in Clinical Orthopedics

H

Hebei Medical University Third Hospital

Status and phase

Unknown
Phase 2

Conditions

Fracture Dislocation

Treatments

Biological: PLGA-Mg material
Biological: titanium alloy

Study type

Interventional

Funder types

Other

Identifiers

NCT03060655
ZYZ2017

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups, including a placebo group

PLGA-Mg material
Placebo Comparator group
Description:
The fixation of fragments of study group was accomplished with PLGA-Mg material.
Treatment:
Biological: PLGA-Mg material
titanium alloy
Placebo Comparator group
Description:
The fixation of fragments of control group was accomplished with titanium alloy material.
Treatment:
Biological: titanium alloy

Trial contacts and locations

0

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Central trial contact

Yingze Zhang, M.D

Data sourced from clinicaltrials.gov

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