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Ankle Fractures clinical trials

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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.

NCT ID: NCT05984433 Recruiting - Pain, Postoperative Clinical Trials

Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture

Start date: October 9, 2023
Phase: N/A
Study type: Interventional

The purpose is to find out if incorporation of an intraoperative electro auricular acupuncture protocol when added to a standard multimodal analgesic regimen for patients undergoing surgery to repair lower leg fracture under spinal anesthesia will help reduce postoperative opioid use.

NCT ID: NCT05916300 Recruiting - Ankle Fractures Clinical Trials

Diagnostic Ultrasonography in Physiotherapy

SonograPHY
Start date: September 18, 2023
Phase:
Study type: Observational

Ankle injuries are among the most common traumatological injuries of the lower limb accounting for approximately 50% of all sports injuries and 25% of musculoskeletal injuries in general. Correct initial diagnosis and proper management is important to reduce the risk of recurrent ankle instability and other complications, such as reduced range of motion, increased ligament laxity, instability, tendon enthesopathy, possible swelling, formation of calcifications, reduced load on the affected limbs while standing and walking, increased pain intensity and pain duration. To date, few studies showed that the effectiveness of physical therapy increases when it is modified based on diagnostic ultrasonography findings. Sonography is not burdensome for the patient, has high reproducibility, and enables dynamic examination and comparison of the interrelationships of individual structures. The aim of this study is to investigate if targeted physiotherapy for post-traumatic ankle conditions designed based of diagnostic ultrasonography findings is more effective than standard physiotherapy. The study hypothesis is that in the experimental group there will be a smaller number of complications of post-traumatic ankle conditions than in the control group. If confirmed the study could have clinical implications.

NCT ID: NCT05798741 Not yet recruiting - Ankle Fractures Clinical Trials

Hardware Removal After ORIF of Ankle Fractures

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

Ankle fractures account for 10 % of fractures in the adult population. A part of patients (40%) is treated surgically. After healing of the fractures, about one year after the operation, a surgery is often performed to remove the hardware in order to diminish pain. If this surgery is necessary is debated in the literature. The aim of our study is to evaluate the outcome of hardware removal surgery after a surgery of the ankle for a fracture. For that, we will perform do a controlled randomized trial with two arms: one arm includes the participants who will have a hardware removal and the other arm will not have a surgery. Outcome parameters are the patients reported outcome and pain related disability. They will be assessed by the questionnaires FAAM score (Foot and Ankle Ability Measure) and PDI (Pain Disability Index) at the beginning and at the end of the study, at six months. The third outcome parameter will be the complication rate after an anklehardware removal surgery, which will be assessed through the Ernst-Ssink classification.

NCT ID: NCT05793606 Not yet recruiting - Clinical trials for Weber B Ankle Fractures

The Effect of Deltoid Ligament Repair in Patients With Weber B Ankle Fracture; Randomized Controlled Trial.

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

Ankle injuries are common in musculoskeletal practice with high incidence rate in physically active individuals. Ankle injuries are complex to managed and further complicated with the high recurrence rate, chronic ankle instability, and osteoarthritis (Herzog et al., 2019). The prime ankle stabilizer against valgus forces is the deltoid ligament, which is a triangle band of strong connective tissues to prevent inward ankle rotation. The deltoid ligament is vital for maintaining ankle stability against valgus forces by its deep and superficial components as it restrains eversion and external rotation of the talus on the tibia (Lee et al., 2019). The superficial components of the deltoid ligament are the tibiospring, tibionavicular, tibiocalcaneal and superficial posterior tibiotalar ligaments, while the deep components are the anterior and posterior tibiotalar ligaments. The deep components of the deltoid ligament are the main stabilizers for the ankle joint, while the superficial components have minimal stabilization role (Michelsen et al., 1996; Pankovich, 2002; Jeong et al., 2014). Retraction of the deltoid ligament could cause medial ankle instability, pain, reduce function and early osteoarthritis (Lee et al., 2019). The deltoid ligament is essential for normal functioning of the foot and ankle and to maintain the normal kinematics of the talocrural kinematics. Dodd, Halai and Buckely (2022) discussed based on Ramsey and Hamilton's (1976) and Lubbeke et al..'s (2012) studies that a one mm lateral shift of the talus reduces the contact area of the tibiotalar up to 42%, and medial-sided injuries including an injury to the deltoid ligament would lead to long-term arthritis (Ramsey and Hamilton, 1976; Lubbeke et al., 2012; Dodd, Halai amd Buckley, 2022). More importantly, the deltoid ligament frequently raptures in association with ankle fractures (Wang et al., 2020). However, a recent systematic review stated that there is no consensus regarding deltoid ligament repair and its associated effectiveness and complications (Dodd, Halai and Buckely, 2022). Moreover, no study has explored the long-term effect of deltoid ligament repair in reducing post-traumatic ankle instability and osteoarthritis in patients with weber B fibula fractures. Therefore, the aim of the study is to determine the effect of deltoid ligament repair in patient with Weber B fibular fracture using randomized controlled trial design and two years follow-up period.

NCT ID: NCT05765929 Recruiting - Clinical trials for Ankle Fracture, Trimalleolar

Use of Weightbearing Radiographs to Determine Treatment of bi- and Trimalleolar Ankle Fractures

Start date: February 28, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the outcomes after non-operative treatment of weightbearing stable bi-and trimalleolar ankle fractures.