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

January 11, 2021 updated by: Histograft Co., Ltd.

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

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

Study Overview

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.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Saint Petersburg, Russian Federation, 194044
        • S.M. Kirov Military Medical Academy, Department of Traumatology and Orthopaedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients aged 18-70 with non-unions of long bones

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
test group
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
gene-activated bone substitute in granular form, concentration of the plasmid DNA is 100 μg per 1.0 g of the OCP scaffold
control group
bone reconstructive surgery with the use of shredded bone autograft harvested from iliac crest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone consolidation
Time Frame: 12 months
Radiographic assessment of bone healing using REBORNE scale
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events and Serious Adverse Events
Time Frame: 12 months
Evaluation of the Adverse Events and Serious Adverse Events frequency
12 months
Ability to use the operated limb
Time Frame: 12 months
Clinical assessment using DASH scale (for upper limb) or LEFS scale (for lower limb)
12 months
Pain level
Time Frame: 12 months
Level of pain measured using Numeric Rating Scale
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2020

Primary Completion (ANTICIPATED)

August 1, 2022

Study Completion (ANTICIPATED)

September 1, 2022

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

January 11, 2021

First Posted (ACTUAL)

January 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Histograft-NONUNION-1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD could be shared through official depositories located on the clinical base official web site

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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