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Fractures, Ununited clinical trials

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NCT ID: NCT06400732 Not yet recruiting - Fractures, Bone Clinical Trials

Post Market Evaluation of Clinical Safety and Performance of the Fitbone Transport and Lengthening System

Start date: May 20, 2024
Phase:
Study type: Observational

The goal of this observational study is to examine and confirm the clinical performance of the Fitbone Transport and Lengthening System in adult patients (21 years and older) who require lower-limb lengthening, fracture fixation and/or treatment for previous non-healing fracture. The main questions it aims to answer are: 1. Are their any unanticipated safety issues with the product when used in a real-world setting? 2. Does the product provide the anticipated clinical benefit when used in a real-world setting? Participants will have been selected by their physician to be treated with the Fitbone Transport and Lengthening System as part of treatment for their condition or injury. All procedures will be according to the physician's standard care practices. There are no study-specific procedures or requirements for participants in this study.

NCT ID: NCT06103396 Enrolling by invitation - Pseudarthrosis Clinical Trials

Treatment of Nonunion Fractures With Mesenchymal Stromal Cells (MSCs)

MSC
Start date: January 30, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this study is to evaluate the bone regeneration capacity of BM-MSC (Bone marrow mesenchymal stromal cells), in patients with nonunion. BM-MSC cultured are seeded on a collagen scaffold, included into autologous platelet-rich plasma (PRP) clot, and implanted in the nonunion bone defect.

NCT ID: NCT06098157 Recruiting - Pseudarthrosis Clinical Trials

Tuebingen Register of Union Failure After Fractures of the Upper and Lower Extremities

TRUFFLE
Start date: January 1, 2020
Phase:
Study type: Observational [Patient Registry]

TRUFFLE is a register of clinical patient data of failed bone healing and bone non-union after fracture. All patients suffering from a long bone delayed or non-union after fracture and undergoing revision surgery are registered with their clinical data, comorbidities, medication, soft tissue status, radiographic status, Non-Union Scoring System (NUSS) Score and are followed up until final bone healing or end of treatment. The register consists of more than 800 patients cases. The aim is to identify risk factors for healing of non-unions. Data analysis will compare those patients that undergo regular healing to those of insufficient healing.

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: NCT05703958 Recruiting - Clinical trials for Proximal Humeral Fracture

Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up

Start date: April 19, 2023
Phase:
Study type: Observational

The objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Proximal Humerus Fracture Plates over time. This study will follow subjects for a period of up to 10 years post-surgery.

NCT ID: NCT05699174 Recruiting - Amputation Clinical Trials

PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation

POvIV2
Start date: May 30, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.

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: NCT05587244 Enrolling by invitation - Clinical trials for Rheumatoid Arthritis

G7 Freedom Constrained Vivacit-E Liners

Start date: May 8, 2023
Phase: N/A
Study type: Interventional

The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit-E Acetabular Liners in primary and revision total hip arthroplasty.

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: NCT04945434 Active, not recruiting - Osteomyelitis Clinical Trials

Clinical Effectiveness of S53P4 Bioactive Glass in Treatment of Long-bone Chronic Osteomyelitis

Start date: September 1, 2011
Phase: N/A
Study type: Interventional

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.