- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Saint Petersburg, Russian Federation, 194044
- S.M. Kirov Military Medical Academy, Department of Traumatology and Orthopaedics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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
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gene-activated bone substitute in granular form, concentration of the plasmid DNA is 100 μg per 1.0 g of the OCP scaffold
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control group
bone reconstructive surgery with the use of shredded bone autograft harvested from iliac crest
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bone consolidation
Time Frame: 12 months
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Radiographic assessment of bone healing using REBORNE scale
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events and Serious Adverse Events
Time Frame: 12 months
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Evaluation of the Adverse Events and Serious Adverse Events frequency
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12 months
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Ability to use the operated limb
Time Frame: 12 months
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Clinical assessment using DASH scale (for upper limb) or LEFS scale (for lower limb)
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12 months
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Pain level
Time Frame: 12 months
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Level of pain measured using Numeric Rating Scale
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12 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Histograft-NONUNION-1.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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