NCT04705857

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

January 13, 2021

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

January 11, 2021

Last Update Submit

January 11, 2021

Conditions

Non Union FractureNon-Union of Ankle Joint Without Infection

Keywords

nonuniongene-activated matrixbone graftingbone substituteVEGFoctacalcium phosphate

Outcome Measures

Primary Outcomes (1)

  • Bone consolidation

    Radiographic assessment of bone healing using REBORNE scale

    12 months

Secondary Outcomes (3)

  • Adverse Events and Serious Adverse Events

    12 months

  • Ability to use the operated limb

    12 months

  • Pain level

    12 months

Study Arms (2)

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

control group

bone reconstructive surgery with the use of shredded bone autograft harvested from iliac crest

Interventions

"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

test group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S.M. Kirov Military Medical Academy, Department of Traumatology and Orthopaedics

Saint Petersburg, 194044, Russia

Location

MeSH Terms

Conditions

Fractures, Ununited

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 12, 2021

Study Start

August 1, 2020

Primary Completion

August 1, 2022

Study Completion

September 1, 2022

Last Updated

January 13, 2021

Record last verified: 2020-08

Locations

RU(1)