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

Non Union Fracture Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04705857
• Other study ID #: Histograft-NONUNION-1.0
• Status: Enrolling by invitation
• Start date: August 1, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: August 2020
• Source: Histograft Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: September 1, 2022
• Est. primary completion date: August 1, 2022
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• traumatic isolated closed or open Gustilo I and II, IIIA and IIIB humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture with a status of atrophic, oligotrophic or normotrophic non-union;

• signed voluntary informed consent

Exclusion Criteria:

• hypertrophic non-union;

• disability or unwillingness to give a voluntary informed consent or follow requirements of the clinical trial;

• segmental bone loss requiring specific therapy (bone transport, vascularized graft, large structural allograft, megaprosthesis, etc);

• other fractures causing interference with weight bearing;

• visceral injuries or diseases interfering with callus formation (severe cranioencephalic trauma, etc.);

• unrecovered vascular or neural injury;

• infection of any location and aetiology;

• pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control;

• malignant tumour (past history or concurrent disease);

• history of bone harvesting on iliac crest contraindicating new iliac crest bone graft harvesting or bone marrow collection;

• conditions limiting study compliance (e.g., dementia, psycho-neurological diseases, drug addiction, and alcoholism);

• medication affecting bone turnover (oral bisphosphonates, PTH, sodium fluoride, strontium ranelate, calcitonin, testosterone, systemic cortico- or anabolic steroids)

Related Conditions & MeSH terms

• Fractures, Ununited
• Non Union Fracture
• Non-Union of Ankle Joint Without Infection

Intervention

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

Locations

Country	Name	City	State
Russian Federation	S.M. Kirov Military Medical Academy, Department of Traumatology and Orthopaedics	Saint Petersburg

Sponsors (2)

Lead Sponsor	Collaborator
Histograft Co., Ltd.	S. M. Kirov Military Medical Academy of the Ministry of Defense of the Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone consolidation	Radiographic assessment of bone healing using REBORNE scale	12 months
Secondary	Adverse Events and Serious Adverse Events	Evaluation of the Adverse Events and Serious Adverse Events frequency	12 months
Secondary	Ability to use the operated limb	Clinical assessment using DASH scale (for upper limb) or LEFS scale (for lower limb)	12 months
Secondary	Pain level	Level of pain measured using Numeric Rating Scale	12 months