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Comparative Study of Gene-activated Bone Substitute and Autobone in Treatment of Long Bone Nonunions

NCT04705857 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2021-01-13

No results posted yet for this study

Summary

The study is aimed to compare the effectiveness of "Histograft" bone substitute (gene-activated bone substitute based on octacalcium phosphate and plasmid DNA encoding VEGFA gene) mixed with shredded autobone and pure shredded auto bone harvested from iliac crest in treatment of patients with long bone nonunions

Conditions

  • Non Union Fracture
  • Non-Union of Ankle Joint Without Infection

Interventions

COMBINATION_PRODUCT

"Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene

gene-activated bone substitute in granular form, concentration of the plasmid DNA is 100 μg per 1.0 g of the OCP scaffold

Sponsors & Collaborators

  • S. M. Kirov Military Medical Academy of the Ministry of Defense of the Russian Federation

    collaborator OTHER

  • Histograft Co., Ltd.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2022-08-01
Completion
2022-09-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04705857 on ClinicalTrials.gov