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Fractures, Ununited clinical trials

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NCT ID: NCT01691833 Completed - Hypovitaminosis D Clinical Trials

The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates

VitD
Start date: February 2011
Phase: N/A
Study type: Interventional

The purpose of the study is to determine whether vitamin D supplementation in patients with hypovitaminosis D can decrease nonunion (failure to heal) incidence in patients with fractures of the humerus, femur, or tibia. The central hypothesis of the study is that vitamin D supplementation in patients with fractures and hypovitaminosis D will decrease the risk of nonunion compared to placebo treatment.

NCT ID: NCT01574833 Completed - Fracture Clinical Trials

Early Application of Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union

Start date: March 2007
Phase: Phase 4
Study type: Interventional

The investigators hypothesized that early applied pulsed electromagnetic field treatment on delayed union might lead to increased rate of fracture union and shortened period of treatment.

NCT ID: NCT01362413 Completed - Clinical trials for Nonunion of Fracture [Pseudarthrosis], Site Unspecified

Validation of Laboratory Test for Predicting Bone Tissue Regeneration

Rebone-test
Start date: January 2011
Phase: N/A
Study type: Observational

The aim of the study is to determine whether the evaluation of pro-osteogenic activity of autologous serum may predict the effectiveness of platelet gel in regenerating bone tissue in patients with nonunions of long bones. Serum samples will be collected before the surgery, and their pro-osteogenic activity will be evaluated by using a bioactivity test (mineralization assay). In order to determine whether the pro-osteogenic activity of the serum is able to discriminate between individuals who will achieve or will not achieve bone consolidation, the laboratory results will be correlated with clinical and radiographic results at 12 months, when patients will be considered as healed or not healed.

NCT ID: NCT01206179 Completed - Nonunion Fractures Clinical Trials

Treatment of Non Union of Long Bone Fractures by Autologous Mesenchymal Stem Cell

Start date: March 2009
Phase: Phase 1
Study type: Interventional

Treatment of nonunion, delayed union and malunion fractures of long bones remains problematic. The definition of nonunion is a failure of the fracture to heal in six months in a patient in whom progressive repair had not been observed radiographically between the third and sixth month after the fracture. First of all good surgical techniques are stable immobilization must be obtained and local sepsis excluded. Then stimulation of the callus is required. Numerous techniques have been developed ranging from invasive interventions (including internal fixation with the use of bone graft or bone graft substitutes) to non invasive procedures (ultrasound and pulsed electromagnetic fields). Recently, autologous cell therapy was presented as an interesting approach. The concept of such therapies is based on the effect of stem cells presented in the bone marrow and able to be transformed in osteoblast cells. The purpose of this study is to find if mesenchymal stem cells can stimulate bone regeneration in nonunion and delayed union fractures to reduce later surgeries required to augment the healing process and to accelerate the time to healing.

NCT ID: NCT00916981 Completed - Pseudarthrosis Clinical Trials

Treatment of Atrophic Nonunion by Preosteoblast Cells

Start date: November 2008
Phase: Phase 1/Phase 2
Study type: Interventional

Treatment of nonunion, delayed union and malunion fractures of long bones remains problematic. The definition of nonunion is a failure of the fracture to heal in six months in a patient in whom progressive repair had not been observed radiographically between the third and sixth month after the fracture. First of all good surgical techniques are stable immobilization must be obtained and local sepsis excluded. Then stimulation of the callus is required. Numerous techniques have been developed ranging from invasive interventions (including internal fixation with the use of bone graft or bone graft substitutes) to non invasive procedures (ultrasound and pulsed electromagnetic fields). Recently, autologous cell therapy was presented as an interesting approach. The concept of such therapies is based on the effect of stem cells presented in the bone marrow and able to be transformed in osteoblast cells. The percutaneous technique of autologous bone-marrow grafting is a minimally invasive alternative able to produce a good healing of the fracture. The efficacy is dependent of the concentration in progenitor cell reinjected. An optimization of this type of treatment could be achieved using a technique to increase the differentiation of the bone marrow cells in preosteoblasts before the injection in situ by an adequate culture. Therefore we would like to start a pilot open study on the feasibility and the efficacy of implantation of preosteoblasts into nonunion. Two different presentations exist: the atrophic and the hypertrophic pseudarthrosis in relationship with radiological features of bone proliferation at the tip of bone fragments. Some data support that atrophic and hypertrophic nonunion fractures could have different physiopathological factors. So, in a first time we only would evaluate the atrophic form and to determine in an open study the effect of the implantation of preosteoblasts into atrophic nonunion.