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Pilon Fracture clinical trials

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NCT ID: NCT06182904 Not yet recruiting - Pilon Fracture Clinical Trials

Management of Pilon Fractures With Versus Without Fibula Fixation

Start date: March 21, 2024
Phase:
Study type: Observational

Management of pilon fractures with versus without fibula fixation

NCT ID: NCT06089525 Recruiting - Pilon Fracture Clinical Trials

Treatment of Complex Pilon Fractures

Start date: August 25, 2023
Phase:
Study type: Observational

This project intends to compare patient outcomes between patients undergoing ORIF compared to PA, or ankle fusion, following an acute pilon fracture. Limited literature comparing ORIF and ankle fusion as a primary procedure exists. Particularly, no present literature exists examining the novel arthrodesis surgical technique utilized in this study in conjunction with Opal sensor gait analysis data. This study will serve as a pilot study and assess patient gait, degree of pain, functional outcome scores, development of post-traumatic arthritis and/or infection, need for secondary surgery, and return to work time.

NCT ID: NCT05280639 Recruiting - Ankle Fractures Clinical Trials

Simplified Post Op Rehabilitation for Ankle and Pilon Fractures

Start date: October 3, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to compare standard post operative rehabilitation with a simplified wooden block stretching protocol that will yield similar results.

NCT ID: NCT05141227 Completed - Pilon Fracture Clinical Trials

Two-stage ORIF Vs Ex. Fix. in Complex Pilon Fractures

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

This study aims to compare the clinical, radiological, and functional outcomes of two-stage open reduction and internal fixation with single-stage external fixation in the treatment of comminuted tibial pilon fractures.

NCT ID: NCT05131321 Recruiting - Ankle Fractures Clinical Trials

Primary Ankle Arthrodesis Versus Open Reduction and Internal Fixation for Fragility Fractures Around the Ankle in the Frail Elderly.

PILON
Start date: April 21, 2022
Phase:
Study type: Observational

This will be a multi-centre randomized controlled trial, with London Health Sciences Centre (LHSC) as the lead site. Elderly patients with complex ankle fractures who meet the inclusion criteria and provide consent will be randomized (through a web-based randomization system) to one of the two treatment arms. One group (Group A) will receive primary ankle fusion, and the second group (Group B) will receive primary ankle open reduction and internal fixation (ORIF). Patient important outcomes will be compared at one year post injury

NCT ID: NCT03652753 Recruiting - Pilon Fracture Clinical Trials

Pilon Fracture With Intra-articular Injection of N-Acetylcysteine (Pilon NAC)

Start date: January 1, 2019
Phase: Phase 4
Study type: Interventional

High energy intra-articular fractures of the distal tibia, or Pilon fracture, is a devastating injury with multiple short and long term complications. The incidence of these injuries is increasing as survival rates after motor vehicle collisions increase. The current standard of care for high energy pilon fractures is to place an external fixator at the time of injury and then provide definitive internal fixation when the soft tissue envelope allows, which is usually around 10-14 days. Arguably, the most debilitating long term complication after a high energy pilon fracture is the development of post-traumatic osteoarthritis (PTOA), which occurs in 50% or more of pilon fractures within the first 2 years of surgery. The development of osteoarthritis occurs even in the presence of adequate restoration of the tibial plafond. Part of this issue lies in the fact that ankle joint cartilage is the thinnest of any major articular joint and sustains a great deal of damage at the time of injury. This impaction and injury initiates a cascade of events that ultimately result in cartilage cell death, or chondrolysis. Chondrolysis occurs via necrosis or apoptosis. Apoptosis occurs via a caspase pathway, while necrosis of chondrocytes likely occurs secondary to overproduction of reactive oxidant species (ROS). Recent animal models have demonstrated several things: chondrocyte death is highest along fracture lines, and likely undergo necrosis as opposed to apoptosis. The reason that PTOA likely occurs in such a high percentage of pilon fractures is because of this chondrolysis, and if a method can be developed to decrease the rate of chrondrocyte necrosis, then the rate of PTOA could potentially improve and improve patient outcomes overall. A recent bovine model examined the injection of N-acetylcysteine (NAC) after an intra-articular knee fracture and its effect on the cartilage cell viability. Their study demonstrated that chondrocyte cell viability after an injection of NAC within four hours of injury decreased chondrolysis from roughly 60% to about 30% at 48hrs. The effect was greater the closer to injury the injection occurred, and was statistically significant for 2 weeks. This indicates that free radical scavengers can potentially improve cartilage cell viability and help prevent the development of PTOA. No studies have been published on humans regarding injection of NAC after a fracture. However, a recent article examined the injection of NAC into osteoarthritic knees and found that it was effective in lowering certain cartilage degradation markers and was comparable to hyaluronic acid for both pain and function. NAC has been proven safe for both intra-articular injections and systemic injections in humans. Our study will focus on the improvement of cartilage cell viability with an injection of NAC. Our hypothesis is that the NAC intra-articular injection will increase the percentage of viable cartilage cell after sustaining a pilon fracture, when compared to a placebo injection of saline. The goal of this study is to examine the effects of an intra-articular injection of the amino acid NAC on cartilage cells after an intra-articular fracture of the ankle joint. The long-term clinical goal of this research is to reduce the incidence of post-traumatic osteoarthritis in the ankle joint after fracture.

NCT ID: NCT03562364 Completed - Clinical trials for Distal Femur Fracture

Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries

AlterG
Start date: February 25, 2019
Phase: N/A
Study type: Interventional

The overall objective of this study is to compare outcomes following early advanced weight bearing (EAWB) using the AlterG antigravity treadmill versus standard of care physical therapy for adult patients with lower extremity periarticular injuries.

NCT ID: NCT02609347 Completed - Ankle Fracture Clinical Trials

Manual Therapy After Ankle/Hindfoot Fractures

Start date: November 2015
Phase: N/A
Study type: Interventional

The aim of this randomized controlled trial is to assess if manual therapy improves mobility, gait, and balance more than a control group for patients who have undergone open reduction internal fixation (ORIF) after an ankle/hindfoot fracture.

NCT ID: NCT01818466 Withdrawn - Arthritis Clinical Trials

Anterior Tibiotalar Arthrodesis With Blade Plate Fixation

Start date: November 2012
Phase: N/A
Study type: Observational

The aim of this study is to evaluate the clinical and radiographic outcomes of patients who have previously undergone tibiotalar arthrodesis using an anterior approach with blade-plate fixation for tibiotalar arthritis secondary to injury to the articular surface of the distal tibia.

NCT ID: NCT01126398 Completed - Ankle Fracture Clinical Trials

Trauma Expectation Factor Trauma Outcome Measure

Start date: February 2007
Phase:
Study type: Observational

This study is designed as a prediction trial. That is, our primary purpose is to develop a model that can be applied clinically as a user-friendly "baseline" questionnaire that is capable of predicting "success" or "failure" based on a patient's pre-surgical expectations of their final outcome. In the process, a secondary goal is to develop an outcomes measure.