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Ankle Fractures clinical trials

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NCT ID: NCT06329752 Not yet recruiting - Ankle Fractures Clinical Trials

Sciatic Nerve Block for Ankle and Leg Fracture Manipulation in the Emergency Department

AnkleMan
Start date: May 2024
Phase: N/A
Study type: Interventional

The goal of this feasibility clinical trial is to assess the acceptability of ultrasound-guided sciatic nerve block when performed at Emergency Departments for manipulation and temporary stabilization of distal leg and ankle fractures. The trial aims to assess: - The acceptability of sciatic nerve block - The technical feasibility of sciatic nerve block - The technical success of sciatic nerve block - The analgesic efficacy of sciatic nerve block In addition to that, this study aims to - Describe patient-reported and physician-reported satisfaction - Assess the Adverse Event rate at 48 hours post intervention

NCT ID: NCT06313177 Recruiting - Clinical trials for Syndesmotic Injuries

Syndesmotic Screw in Neutral Position Versus Maximum Ankle Dorsiflexion in Ankle Fractures; Comparative Study.

Start date: March 10, 2024
Phase: N/A
Study type: Interventional

Ankle fracture is one of the most common orthopedic injuries. Approximately, 20% of surgically treated ankle fractures are associated with syndesmotic instability.According to the mechanism of the injury the syndesmotic disruption should be considered in Danis-Weber C-type fractures. However, such injuries were also frequently seen in Danis-Weber B-type fractures. Failure to detect and repair syndesmotic injuries early may result in poor clinical outcomes and complications affecting ankle function, such as long-term residual pain, post traumatic arthritis, and ankle impingement syndromes. Therefore, aggressive treatment is important when facing syndesmotic instability . The distal tibiofibular syndesmosis is important for stability of the ankle mortise and thus for weight transmission and walking. Syndesmotic injuries are most commonly associated with fibular fractures, but they can also occur in isolation or with damage to the lateral ankle ligament after traumatic supination. The need for syndesmotic fixation of the distal tibiofibular joint has been controversia. fracture does not correlate reliably with the extent of the interosseous membrane tears identified on MRI of ankle fractures, and thus estimation of the integrity of the interosseous membrane and subsequent need for trans-syndesmotic fixation cannot be based solely on the level of the fibular fracture. An intraoperative syndesmotic stress test can establish the presence or absence of syndesmotic instability, evaluating the integrity of the syndesmosis by grasping the stabilised fibula with a hook or clamp and pulling it laterally. If more than 3 or 4 mm of lateral displacement occurs, syndesmotic fixation is necessary. Most authors recommend surgical placement of a trans-fixation screw after anatomical reduction of the syndesmosis if a disruption is diagnosed to avoid complications.The main aims of treatment for dislocation of the distal tibiofibular syndesmosis are to restore the original anatomy and normal function and to recreate the stability of the ankle joint. The syndesmosis is traditionally fixed with a metallic screw, which is a method that has been used for decades and demonstrates good to excellent outcomes. Some surgeons prefer Fixation of syndesmosis with screw in maximum ankle dorsiflexion and others prefer fixation in neutral position of ankle.in this study we are going to compare between these two

NCT ID: NCT06303284 Not yet recruiting - Ankle Fractures Clinical Trials

Post-surgical Outcomes With Anabolic Agent Use in High-risk Ankle Fractures: A Pilot RCT

Start date: January 1, 2025
Phase: Phase 1/Phase 2
Study type: Interventional

As the global population ages and the prevalence of poor bone health increases among older patients with ankle fractures, so does the risk of post-surgical complications. Prevention of post-surgical complications is of paramount importance to reducing morbidity, mortality, and healthcare costs. There is growing evidence to support the use of bone-building medications, such as Teriparatide, in patients who have delayed fracture healing or non-unions; however, these medications have yet to be investigated in elderly patients with ankle fractures at high risk for delayed fracture healing and post-operative complications. This project aims to assess the safety and efficacy of short-term Teriparatide use in improving outcomes in a population most likely to suffer post-operative complications. The proposed study is a pilot randomized controlled trial (RCT) with patients 60 years or older with an additional risk factor for delayed healing (i.e., osteoporosis, diabetes, vascular disease) who require ankle fracture surgery. Participants will be randomized to receive the study medication (Teriparatide) or placebo for three months. The primary objective of this study is to acquire vital data (i.e., recruitment rates, follow-up rates, adherence to treatment assignment) required to determine the feasibility of a full-scale multi-centre RCT. Additional aims are to evaluate repeat surgery, complications, time-to-union, and 90-day mortality. A complete a socio-economic and feasibility analysis will be completed. This study will evaluate the novel clinical approach of augmenting surgical fixation with a medication to build bone density and strength, thereby improving bone health, preventing complications, and improving outcomes. This study will also inform planning for a larger clinical trial to reduce the morbidity, mortality, and cost associated with complications in this high-risk population.

NCT ID: NCT06293209 Active, not recruiting - Ankle Fractures Clinical Trials

Effect of Cool Spray and Cold Packs in Reducing Preoperative Edema and Pain in Ankle Fractures in Ubonratchathani

3-armRCT
Start date: August 1, 2023
Phase: N/A
Study type: Interventional

The use of evaporative coolants in the management of acute musculoskeletal injury has received increasing attention recently. However, its efficacy compared with conventional cryotherapy in treating injured human subjects remains unclear. The purpose of this study is to compare the efficacy of evaporative coolants with that of ice packs in the preoperative management of edema and pain in patients with an ankle fracture

NCT ID: NCT06086223 Not yet recruiting - Ankle Fractures Clinical Trials

Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The aim of our study is to identify if there is statistically significant difference in patient reported functional outcomes in cases of unstable ankle fracture managed by ORIF with and without ankle arthroscopy.

NCT ID: NCT06085586 Recruiting - Ankle Fractures Clinical Trials

Fibulink Syndesmosis Repair System With Early Full-Weight Bearing

Start date: July 13, 2023
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the ability of the Fibulink Syndesmosis Repair System to maintain reduction of the ankle syndesmosis. Appropriate reduction of the syndesmosis is critical due the changes in tibiotalar contact pressure observed in cadaveric studies.6,7 Malreduction and instability of the distal tibiotalar joint can lead to chronic instability, increased articular damage and ultimately degenerative arthritis.7,8 Medial to lateral translation of distal tibia and fibula of 2 mm or more has been considered pathologic.9 Earlier biomechanical study demonstrated the Fibulink system is superior in maintaining displacement of less than 2 mm.4 Given the improved strength, we also look to evaluate the outcomes of initiating full weight bearing (100%) with Controlled Ankle Motion (CAM) boot at 4 weeks postoperatively. One of the big limitations for trans-osseous screw fixation is delayed weight bearing due to risk of screw breakage.1 Suture button technique allowed for early weight bearing with average of 6 weeks postoperatively using TightRope.2,10-12By initiating full weight bearing (100%) with CAM boot at 4 weeks postoperatively, this would be a significant improvement in current clinical practice.

NCT ID: NCT06078371 Not yet recruiting - Clinical trials for Femoral Neck Fractures

Opioid-Free Pain Treatment in Trauma Patients

Start date: October 2023
Phase: N/A
Study type: Interventional

Analgesic drug study that will compare pain outcomes of opioid analgesia and opioid-free analgesia in post-operative orthopedic patients.

NCT ID: NCT06077344 Recruiting - Ankle Fractures Clinical Trials

WALANT and Spinal Anesthesia Comparison of Clinical Result in Ankle Fractures

Start date: April 15, 2023
Phase:
Study type: Observational [Patient Registry]

The application of the WALANT technique for foot and ankle surgery (joint fusion, implant removal and tendon repair, etc.) is limited. In our study, using the WALANT technique for ARIF in ankle fractures. The effect of this application on clinical outcomes will be prospectively evaluated.

NCT ID: NCT06062797 Recruiting - Ankle Fractures Clinical Trials

Improving Patient Understanding in Preoperative Informed Consent Process of Trauma Patients Using a Mixed Reality Viewer

Start date: April 18, 2023
Phase: N/A
Study type: Interventional

This clinical trial aims to compare a Mixed Reality Viewer in the preoperative informed consent process to standard fracture visualization. The participants population are patients with an indication for surgery of a distal radius fracture, upper ankle fracture or proximal humerus fracture using plate osteosynthesis. The main questions aim to answer are: - Does the use of the Mixed Reality Viewer improve patient understanding? - Does the use of the Mixed Reality Viewer improve patient satisfaction? - Does the use of the Mixed Reality Viewer reduce patient preoperative anxiety? Participants will have their fracture presented via the Mixed Reality Viewer. Researchers will compare standard fracture imaging using X-ray or CT scans to see if there is any difference in understanding, satisfaction and anxiety.

NCT ID: NCT06023979 Not yet recruiting - Clinical trials for Post Operative Treatment After Unstable Malleolar Fractures

Early Protected Full Weight-bearing vs. Partial Weight-bearing After Surgical Fixation of Unstable Ankle Fractures, Monitored With Bio-feedback Insoles.

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the postoperative results after ORIF (Open Reduction Inner Fixation) with a partial weight-bearing protocol versus an early full weight-bearing protocol. But in addition, we will measure every patient's actual load by the means of walker integrated bio-feedback insoles for the first six postoperative weeks to record the adherence to the protocol.