Comparative Study of Gene-activated Bone Substitute and Autobone in Treatment of Long Bone Nonunions (NCT04705857) | Clinical Trial Compass
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Comparative Study of Gene-activated Bone Substitute and Autobone in Treatment of Long Bone Nonunions
Russia20 participantsStarted 2020-08-01
Plain-language 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
Who can participate
Age range18 Years – 70 Years
SexALL
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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)