Non Union FractureNCT04705857
Comparative Study of Gene-activated Bone Substitute and Autobone in Treatment of Long Bone Nonunions
An observational study of Non Union Fracture and Non-Union of Ankle Joint Without Infection, run by Histograft Co., Ltd. at 1 site in Russia.
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non Union Fracture, Non-Union of Ankle Joint Without Infection
- What is being tested?
- "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene
- How many people
- 20 participants
- Where
- 1 siteRussia
- Study dates
- 1 Aug 2020to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: patients aged 18-70 with non-unions of long bones
Who may be able to join
- 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
Who cannot join
- 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;
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Russia1 site
S.M. Kirov Military Medical Academy, Department of Traumatology and Orthopaedics
Saint Petersburg, 194044
About this study
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
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
Read the 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.
- Being tested
- "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene
- Keywords
- nonunion, gene-activated matrix, bone grafting, bone substitute, VEGF, octacalcium phosphate
- Medical subject headings
- Fractures, Ununited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA geneCombination product
gene-activated bone substitute in granular form, concentration of the plasmid DNA is 100 μg per 1.0 g of the OCP scaffold
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Combination Product: "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene | |
| control group | bone reconstructive surgery with the use of shredded bone autograft harvested from iliac crest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone consolidation
Radiographic assessment of bone healing using REBORNE scale
Measured: 12 months
Secondary outcomes (3)
Adverse Events and Serious Adverse Events
Evaluation of the Adverse Events and Serious Adverse Events frequency
Measured: 12 months
Ability to use the operated limb
Clinical assessment using DASH scale (for upper limb) or LEFS scale (for lower limb)
Measured: 12 months
Pain level
Level of pain measured using Numeric Rating Scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start1 Aug 2020
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Union FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Histograft Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- S. M. Kirov Military Medical Academy of the Ministry of Defense of the Russian Federation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705857
- Sponsor's protocol ID
- Histograft-NONUNION-1.0
- Status last verified
- Aug 2020
- First submitted
- 11 Jan 2021
- Last updated
- 13 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD could be shared through official depositories located on the clinical base official web site
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04705857
- Acronym / sponsor ID
- Histograft-NONUNION-1.0
- Keywords
- nonunion, gene-activated matrix, bone grafting, bone substitute, VEGF, octacalcium phosphate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Histograft Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- S. M. Kirov Military Medical Academy of the Ministry of Defense of the Russian Federation
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | – | Combination Product: "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA genebone 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 |
| control group | – | –bone reconstructive surgery with the use of shredded bone autograft harvested from iliac crest |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients aged 18-70 with non-unions of long bones
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA genegene-activated bone substitute in granular form, concentration of the plasmid DNA is 100 μg per 1.0 g of the OCP scaffold | Combination product | test group |
Primary outcome
Bone consolidation
Time frame: 12 months
Radiographic assessment of bone healing using REBORNE scale
3 secondary outcomes
Adverse Events and Serious Adverse Events
Time frame: 12 months
Ability to use the operated limb
Time frame: 12 months
Pain level
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Individual participant dataSharing planned: Undecided. IPD could be shared through official depositories located on the clinical base official web site
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Union Fracture and Non-Union of Ankle Joint Without Infection, run by Histograft Co., Ltd. at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone consolidation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.