Active clinical trials for "Fractures, Ununited"

The present study evaluates the effect of XCEL-MT-OSTEO-ALPHA in non-union fractures (pseudoarthrosis) of long bones in comparison to the standard treatment of autologous iliac crest. XCEL-MT-OSTEO-ALPHA is a tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue, produced by Xcelia (Blood and Tissue Bank of Catalonia). The working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration up to consolidation of non-union fractures.

Here the investigators describe the statistical analysis plan for the study assessing the prediction of fracture nonunion leading to secondary surgery in patients with distal femur fractures.

Bone fractures heal most of the time particularly well and without complications. The solidification takes rarely more than two to three months. The wound healing depends greatly on a good blood supply and needs several steps. These processes culminate in a new mass of heterogeneous tissue which is known as the fracture callus. Unfortunately, 2%-5% bone fractures cannot achieve a proper solidification and between the ununited fragments a scar tissue appears. This incorrect healing induces pain and even infections. When this situation persists more than 6 months, it is referred to as nonunion fracture, which will require some form of intervention to stimulate the natural healing process of the body. First of all, good surgical techniques with stable immobilization should be applied and local infection should be excluded. Then stimulation of the callus is required. Cell therapy with bone marrow cells has emerged as a promising new approach for bone regeneration. Animal studies as well as preliminary human studies have shown that Mesenchymal Stem Cells, a particular kind of stem cells isolated from the bone marrow, could induce callus formation when injected in the nonunion site of a broken bone. In this study the investigators aim at determining whether Mesenchymal Stem Cells (MSC) isolated from the patient's bone marrow and injected in the nonunion site could be a safe and effective treatment for nonunion fractures. Patients will be randomized in two groups; one injected with Mesenchymal Stem Cell and the other injected with placebo. The investigators seek also to know how long it takes to develop the callus formation and whether there is a partial or a complete callus formation.

Mesenchymal stem cell (MSC) is one kind of stem cell which is gained form adult tissue. Although MSC derived from autogenic bone marrow are proven to help regeneration in non union fracture and long bone defect, the aspiration process through iliac crest is invasive and painful. Therefore, alternative source of MSC which is less invasive is needed. Adipose and umbilical cord is a "waste product" that proven to contain enormous MSC. Furthermore adipose and umbilical cord as an allogenic source is more abundant in number compares to autogenic bone marrow. This enormous source need and adequate preservation technique before applied to the patient. According to that, researchers want to explore the potency of MSC from bone marrow, umbilical cord and adipose as the source of allogenic MSC and the effect of cryopreservation technique to the viability and quality of MSC. We will also compare the effectivity of MSC implantation from bone marrow, umbilical cord and adipose applied to non union fracture and long bone defect. Samples from bone marrow, umbilical cord and adipose are cultured and the viability of the cells are observed. Some of the cells are implanted directly to the patient with non union fractures and long bone defect while some are cryopreserved in liquid nitrogen -190 degree Celsius in three months. All samples are thawed and the viability of the cells are observed. Patient who are implanted by MSC allogenic will undergo clinical and radiological examination in the third, sixth and twenty second month after implantation.

To objectively analyze the effectiveness of platelet-rich plasma (PRP) combined with conventional surgery in the treatment of atrophic nonunion of femoral shaft fractures.

Because the rate of non union of long bone in lower extremities specially in tibia in this two last decade due to malnutrition and smoking and other risk factors was increased, so many patient in our country suffer from non union. On the other hand it seems that the use of the mesenchymal stem cells can irritate the union rate. Also for better result we used the mesenchymal stem cells with BMP2 in collagenic scaffold. The collagen has a osteoconductive effect and BMP2 and stem cells has a osteoinductive effect therefore this combination is useful in filling the gap in non union site and irritate the union rate. Mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure. Then the investigators will follow the patient with monthly radiography and evaluate the callus volume and clinical union and any side effect of this treatment. Clinical union consider to relief pain in non union site and be stable in examination.

The purpose of this clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a prospective database.

The purpose of this study is to evaluate the efficacy and safety of human amniotic epithelial cells transplant in nonunion of limb fracture patients.

This clinical trial studies the clinical effectiveness of S53P4 bioactive glass (BAG) as a bacterial growth inhibiting bone graft substitute in a one-stage or two-stage surgical procedure for treatment of chronic long bone osteomyelitis.

This is a multi-centered, prospective, randomized controlled trial comparing current standard of care for defect management to placement of antibiotic loaded Stimulan as a bone void filler in patients undergoing treatment of infected tibial defects or infected tibial nonunions.