Comparative Study of Gene-activated Bone Substitute and Autobone in Treatment of Long Bone Nonunions
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|ClinicalTrials.gov Identifier: NCT04705857|
Recruitment Status : Unknown
Verified August 2020 by Histograft Co., Ltd..
Recruitment status was: Enrolling by invitation
First Posted : January 12, 2021
Last Update Posted : January 13, 2021
|Condition or disease||Intervention/treatment|
|Non Union Fracture Non-Union of Ankle Joint Without Infection||Combination Product: "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene|
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.
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||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|
|Actual Study Start Date :||August 1, 2020|
|Estimated Primary Completion Date :||August 1, 2022|
|Estimated Study Completion Date :||September 1, 2022|
bone reconstructive surgery with the use of "Histograft" bone substitute (gene-activated matrix based on octacalcium phosphate and plasmid DNA encoding VEGFA gene) mixed with shredded autobone (in a ratio of 50/50) harvested during the surgery
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
bone reconstructive surgery with the use of shredded bone autograft harvested from iliac crest
- Bone consolidation [ Time Frame: 12 months ]Radiographic assessment of bone healing using REBORNE scale
- Adverse Events and Serious Adverse Events [ Time Frame: 12 months ]Evaluation of the Adverse Events and Serious Adverse Events frequency
- Ability to use the operated limb [ Time Frame: 12 months ]Clinical assessment using DASH scale (for upper limb) or LEFS scale (for lower limb)
- Pain level [ Time Frame: 12 months ]Level of pain measured using Numeric Rating Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04705857
|S.M. Kirov Military Medical Academy, Department of Traumatology and Orthopaedics|
|Saint Petersburg, Russian Federation, 194044|