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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Bone consolidation
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Bone consolidation
时间窗: 12 months
Radiographic assessment of bone healing using REBORNE scale
次要结局
- Ability to use the operated limb(12 months)
- Pain level(12 months)
- Adverse Events and Serious Adverse Events(12 months)