Status:
UNKNOWN
Comparative Study of Gene-activated Bone Substitute and Autobone in Treatment of Long Bone Nonunions
Lead Sponsor:
Histograft Co., Ltd.
Collaborating Sponsors:
S. M. Kirov Military Medical Academy of the Ministry of Defense of the Russian Federation
Conditions:
Non Union Fracture
Non-Union of Ankle Joint Without Infection
Eligibility:
All Genders
18-70 years
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04705857
Start Date
August 1 2020
End Date
September 1 2022
Last Update
January 13 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
S.M. Kirov Military Medical Academy, Department of Traumatology and Orthopaedics
Saint Petersburg, Russia, 194044