Clinical trial NCT04705857: Comparative Study of Gene-activated Bone Substitute and Autobone in Treatment of Long Bone Nonunions
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Union Fracture
Non-Union of Ankle Joint Without Infection
Keywords: nonunion
gene-activated matrix
bone grafting
bone substitute
VEGF
octacalcium phosphate
Lead sponsor: Histograft Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: S. M. Kirov Military Medical Academy of the Ministry of Defense of the Russian Federation
First posted: 2021-01-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients aged 18-70 with non-unions of long bones

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

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.

Eligibility 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)

Primary outcomes:
measure: Bone consolidation
timeFrame: 12 months
Secondary outcomes:
measure: Adverse Events and Serious Adverse Events
timeFrame: 12 months
measure: Ability to use the operated limb
timeFrame: 12 months
measure: Pain level
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: S.M. Kirov Military Medical Academy, Department of Traumatology and Orthopaedics
Study officials:
References: