Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT04705857
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)
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04705857
Study Brief:
Protocol Section:
NCT04705857