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Tibial Fractures clinical trials

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NCT ID: NCT05859451 Recruiting - Smoking Clinical Trials

Effect of Tobacco Heating System (THS) on Closed Tibia Fracture Healing

Start date: June 2, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to investigate the role of switching from cigarette smoking (CS) to tobacco heat system (THS) on the clinical outcome of closed tibia fractures from smokers' orthopedic patients. Validated and standardized assays, medical state and self-reported outcomes will be evaluated in orthopedic patients' smokers or switch from CS to using THS throughout six months compare to ex-smokers (control).

NCT ID: NCT05843864 Recruiting - Clinical trials for Stress Fracture of Tibia

Photobiomodulation Therapy for the Treatment of Lower Extremity Stress Fractures in a Military Training Setting

PM12
Start date: June 7, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare photobiomodulation therapy (PBMT) in addition to standard of care in the treatment of tibial and metatarsal bone stress injuries in a military training setting. Participants will all receive usual care and also be randomized to either active or sham photobiomodulation therapy. Effectiveness will be assessed based on time to return to duty and measures of pain and function. - Participants will receive care for a maximum of 6 weeks. - Participants will have follow-up through 4 months (or graduation/dismissal from training, whichever comes first).

NCT ID: NCT05766670 Not yet recruiting - Tibial Fractures Clinical Trials

Intramedullary Calcium Sulfate Antibiotic Depot

Start date: June 2024
Phase: Phase 3
Study type: Interventional

The goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. The main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate antibiotic depot is better at preventing infection that the standard of care.

NCT ID: NCT05668182 Recruiting - Femoral Fracture Clinical Trials

A Case Series: TRUMATCH Graft Cage for Segmental Long Bone Defects

Start date: June 29, 2021
Phase:
Study type: Observational

This project consists of a prospective case design. Study candidates will include all patients ages 18 and over who were evaluated at UCSD and found to have a critical-sized humerus, femur, or tibia segmental defect that would be fixed through surgery. Patients who consent to study participation will receive the TRUMATCH Graft Cage for their long bone segmental defect repair. Data on healing rates, complication rates, re-operation rates, time to return to normal activity, and pain levels will be collected for each participation. After 3 years of data collection, we will analyze this data to provide further insight on the utility of the TRUMATCH Graft Cage. Given the significant difficulty with repairing segmental long bone defects, it is imperative to evaluate novel systems to appropriately manage these injuries.

NCT ID: NCT05652881 Recruiting - Tibial Fractures Clinical Trials

Does Joint Lavage Reduce Intraarticular Inflammation in High-energy Tibial Pilon Fractures?

Start date: January 15, 2023
Phase: N/A
Study type: Interventional

High-energy tibial pilon fractures have historically been associated with poor outcomes largely due to the elevated risk of severe post-traumatic arthritis. Intraarticular fractures result in a pro-inflammatory hemarthrosis that may further exacerbate the chondral damage that was sustained due to the original injury. This project will study the effect of joint lavage on the concentration of inflammatory cytokines in the ankle following a high-energy tibial pilon fracture and the resultant effect on short-term patient outcomes.

NCT ID: NCT05615844 Recruiting - Open tíbia Fracture Clinical Trials

Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy

BeadsvsVac
Start date: November 5, 2023
Phase: Phase 3
Study type: Interventional

The Beads vs Vac trial is a multi-centre randomized controlled trial of 312 participants with a severe open tibia fracture requiring multiple irrigation and debridement surgeries. Eligible participants will be randomized to receive either an antibiotic bead pouch or negative pressure wound therapy (NPWT) for their temporary open fracture wound management. Outcomes will be assessed at 6 weeks, 3 months, and 6 months post-surgery. The primary outcome will be a composite outcome to evaluate clinical status six months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) injury-related amputation of the lower extremity, 3) unplanned reoperation to manage wound complications, infection, or delayed fracture healing, and 4) clinical fracture healing as assessed using the Functional IndeX for Trauma (FIX-IT) instrument. The secondary outcomes will independently assess the four components of the primary outcome. This is a Phase III trial.

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: NCT05536622 Recruiting - Fractures, Bone Clinical Trials

Hi-Res IR Thermography for the Diagnosis of Toddler's Fractures

Start date: February 11, 2021
Phase: N/A
Study type: Interventional

This is a pilot proof of feasibility study to explore the efficacy of high resolution thermal imaging (HRTI) to screen for toddler's fractures. In HRTI, a sensitive thermal camera is used to capture the temperature profile of the suspected fracture region and then analyse and interpret the information using image processing. Toddler's fractures are a common type of tibial fracture in children under 5 years old that can be particularly difficult to detect as the bone typically appears normal on x-ray for the first 10 days and becomes detectable thereafter only as new bone forms. The child's leg is put in plaster in the interim and the diagnosis cannot be confirmed until 10-14 days later. Around 60% of children with suspected toddler's fracture will not have a fracture, and would therefore have had plaster, repeat attendances and repeat x-ray unnecessarily. There is also the inconvenience and general risks of plaster immobilisation for the child. In an earlier study, the investigators demonstrated that HRTI has potential in diagnosing limp in children. This study included two children with toddler's fracture where HRTI detected the fracture's location on the patient's first Emergency Department(ED) visit. In this study, the investigators aim to build on earlier work to explore HRTI for screening for toddler's fracture. On its successful completion, the investigators aim to develop the technology in a follow on larger diagnostic study as a tool that could be used to quickly exclude cases where the injury has not resulted in a fracture. This would allow more objective decision making during the initial assessment of the child. In addition, a reduction in the number of unnecessary x-rays, revisits, treatment as well as cost is anticipated.

NCT ID: NCT05502679 Recruiting - Clinical trials for Fracture of Tibia Proximal Plateau

Immediate Versus Late Weight Bearing After Tibial Plateau Fractures Internal Fixation

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Postoperative rehabilitation for tibial plateau fracture generally involves prolonged non-weight bearing time while other protocols use partial weight-bearing and bracing before full weight-bearing is recommended at 9 to 12 weeks following surgical fixation. No study to date has investigated the effect of standardized pragmatic exercise protocol added to immediate weight bearing after tibial plateau fractures surgical fixation on patient's functional outcomes, knee ROM, pain, radiographic boney alignment, gait, and return to work.

NCT ID: NCT05501496 Not yet recruiting - Fracture of Tibia Clinical Trials

Conservative Versus Intramedullary Nailing for Pediatric Tibial Shaft Fractures

CINPED
Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Tibial shaft fracture is a common fracture in the pediatric and adolescent population. The outcomes of both conservative and operative treatment are not clear and to date there is no randomized prospective trial comparing different methods of treatment. The investigators will conduct a multicenter, randomized non-inferiority trial comparing closed reduction and cast immobilization to intramedullary nailing in 6-15 year old children and adolescents with displaced tibial shaft fractures and open proximal tibial physis.