NCT04705857

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

Comparative Study of Gene-activated Bone Substitute Based on Octacalcium Phosphate and Plasmid DNA Encoding VEGFA Gene Mixed With Autobone and Bone Autograft From Iliac Crest in Treatment of Long Bone Nonunions With Bone Loss: an Open-label Randomized Controlled Trial

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Histograft Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: —

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

Detailed description

An open-label randomized controlled clinical trial, two cohorts. Patients who met the inclusion criteria are planned to be enrolled into the trial. Upon enrollment, all patients will undergo screening, a set of clinical examination, instrumental investigations and laboratory tests, including CT of the affected bone with the assessment of nonunion. All patients enrolled in the study will be subjected to bone reconstructive surgery with nonunion excision and bone grafting with either investigational bone substitute mixed with shredded autobone (in a ratio of 50/50) harvested during the surgery or pure shredded autobone from iliac crest. The clinical study results will be evaluated at the time points of 1, 15, 45, 90, 180 days with clinical examination, instrumental investigations and laboratory tests. Control CT will be carried out for the primary outcome measure at 90, 180, 360 days after surgery.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-08-01
• Primary completion: 2022-08-01
• Completion: 2022-09-01
• First posted: 2021-01-12
• Last updated: 2021-01-13

Locations

1 site across 1 country: Russia