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Fractures, Ununited clinical trials

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NCT ID: NCT06005090 Completed - Clinical trials for Nonunion of Fracture of Tibia

Is Far Cortical Locking More Effective Than Bicortical Locking in Treating AO 43A1-3 Fractures?

Start date: April 1, 2020
Phase:
Study type: Observational

Delayed union or nonunion, which is a common complication of periarticular fractures repaired with angled locking plate systems, may be due to the unintentionally rigid formation of this system. This study aimed to compare the results of the treatment of distal tibial fractures made more flexible using the far cortical locking (FCL) technique with the classical bicortical locking screw (BL) technique.

NCT ID: NCT05613257 Completed - Tibial Fractures Clinical Trials

Distal Targeter vs Free-hand

Start date: October 31, 2022
Phase: N/A
Study type: Interventional

This study is a randomized controlled trial comparing the use of two different surgical techniques--free-hand versus distal targeting jig-based for distal interlock screw--placement and their effects on total operative time and intraoperative radiation exposure.

NCT ID: NCT05163795 Completed - Clinical trials for Nonunion of Fracture

Distal Femur Fracture Nonunion - Statistical Analysis Plan

Start date: May 15, 2019
Phase:
Study type: Observational

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.

NCT ID: NCT04340284 Completed - Clinical trials for Nonunion of Fracture

Adipose Tissue Derived Stromal Vascular Fraction (SVF) Application in Treatment of Long Bones Nonunion

Start date: November 10, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Nonunion is a major complication of fractures.Per cutaneous bone marrow concentrate (BMC) application around fracture ends is being utilized with great success . Mesenchymal Stem Cells (MSCs)are one of the major cell types found in BMC responsible for results Adipose tissue is an alternative source for MSCs. Besides abundant and readily accessible it also overcomes issue of morbidity with bone marrow aspiration. this retrospective analysis to report the outcome in patients treated with fluoroscopic guided percutaneous injection of SVF at the site of fracture as an outpatient procedure between November 2012 to August 2018.

NCT ID: NCT03928912 Completed - Clinical trials for Nonunion of Fracture of Tibia (Diagnosis)

Risk Factors for Post-Operative Nonunion of Tibial Shaft Fractures Based on a Path Analysis Model

Start date: February 2, 2019
Phase:
Study type: Observational

Tibial shaft fractures is common long tubular fracture that account for about 13.7% of all fractures. And the incidence of nonunion of tibial shaft fracture varied from 1% to 80%. This study aimed to confirm the risk factors of nonunion of tibial shaft fracture. Moreover, the investigators hope to establish the clinical pathway of various risk factors for fracture nonunion and affirm the importance of different risk factors.

NCT ID: NCT03415958 Completed - Clinical trials for Malunion of Fracture of Clavicle

A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures

Start date: March 28, 2012
Phase: N/A
Study type: Observational

Outcomes for displaced midshaft clavicle fractures in adolescents are not defined. The current method of treatment for these fractures is non-operative management. There is recent Level 1 evidence in the adult literature to suggest that outcomes are superior when these fractures are managed surgically with open reduction and internal fixation.

NCT ID: NCT02230514 Completed - Clinical trials for Atrophic Nonunion of Fracture

Mesenchymal Stromal Cells for the Treatment of Non-union Fractures of Long Bones

Start date: November 20, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

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.

NCT ID: NCT02177565 Completed - Clinical trials for Non-union of Fractures

Autologous Stem Cell Therapy for Fracture Non-union Healing

Start date: January 2000
Phase: N/A
Study type: Interventional

Do mesenchymal stem cells accelerate new bone formation in persistent non-unions.

NCT ID: NCT02020590 Completed - Clinical trials for Long Bone Delayed-Union Fracture

Phase 1/2a Study on Allogeneic Osteoblastic Cells Implantation in Delayed-Union Fractures

Start date: February 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Fracture healing is a complex physiological process caused by interaction of cellular elements, cytokines and signaling proteins, which results in the formation of new bone. There is for now no universally accepted approach to evaluate the progression of fracture healing. Typically, a fracture is considered as a delayed-union when the bone has not united within a period of time that would be considered adequate for bone healing. Delayed-union suggests that union is slow but will eventually occur without additional surgical or non-surgical intervention, whereas non-union is defined as the cessation of all reparative process of healing. The incidence of impaired healing is estimated to range from 5 to 10% of all long bone fractures, depending on the fracture site, the type and degree of injury, among other factors. Currently the treatment of choice remains bone allograft or autograft. This procedure shows in general good results but requires an invasive surgery of several hours under general anesthesia, followed by a few days of hospitalization. Because of this, major complications have been reported in up to 20-30% of patients. The present Phase 1/2a study aims at demonstrating the safety and efficacy of ALLOB®, a proprietary population of allogeneic osteoblastic cells, in the treatment of delayed-union fractures of long bones. In this study, delayed-union is defined at the time of screening as an absence of healing of minimum 3 months and maximum 7 months (+/- 2 weeks) after the onset of the fracture.

NCT ID: NCT01788059 Completed - Nonunion Fracture Clinical Trials

The Efficacy of Mesenchymal Stem Cells for Stimulate the Union in Treatment of Non-united Tibial and Femoral Fractures in Shahid Kamyab Hospital

Start date: January 2013
Phase: Phase 2
Study type: Interventional

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. Therefore the investigators decide to inject the mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure to non union site in patient that are resistant to other treatment. 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.