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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04705857
Recruitment Status : Enrolling by invitation
First Posted : January 12, 2021
Last Update Posted : January 13, 2021
Sponsor:
Collaborator:
S. M. Kirov Military Medical Academy of the Ministry of Defense of the Russian Federation
Information provided by (Responsible Party):
Histograft Co., Ltd.

Study Description
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Brief 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

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

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 Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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
 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
control group
bone reconstructive surgery with the use of shredded bone autograft harvested from iliac crest


Outcome Measures
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Primary Outcome Measures :
  1. Bone consolidation [ Time Frame: 12 months ]
    Radiographic assessment of bone healing using REBORNE scale


Secondary Outcome Measures :
  1. Adverse Events and Serious Adverse Events [ Time Frame: 12 months ]
    Evaluation of the Adverse Events and Serious Adverse Events frequency

  2. Ability to use the operated limb [ Time Frame: 12 months ]
    Clinical assessment using DASH scale (for upper limb) or LEFS scale (for lower limb)

  3. Pain level [ Time Frame: 12 months ]
    Level of pain measured using Numeric Rating Scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
patients aged 18-70 with non-unions of long bones
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Russian Federation
S.M. Kirov Military Medical Academy, Department of Traumatology and Orthopaedics
Saint Petersburg, Russian Federation, 194044
Sponsors and Collaborators
Histograft Co., Ltd.
S. M. Kirov Military Medical Academy of the Ministry of Defense of the Russian Federation
More Information
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Responsible Party: Histograft Co., Ltd.
ClinicalTrials.gov Identifier: NCT04705857    
Other Study ID Numbers: Histograft-NONUNION-1.0
First Posted: January 12, 2021    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD could be shared through official depositories located on the clinical base official web site

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Histograft Co., Ltd.:
nonunion
gene-activated matrix
bone grafting
 bone substitute
VEGF
octacalcium phosphate
Additional relevant MeSH terms:
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Fractures, Ununited
Fractures, Bone
Wounds and Injuries