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Ankle Fractures clinical trials

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NCT ID: NCT06370325 Not yet recruiting - Ankle Fractures Clinical Trials

Neuromuscular Electrical Stimulation in Foot and Ankle Surgery

Start date: April 2024
Phase: N/A
Study type: Interventional

This is a pilot randomized controlled trial, wherein the intervention group will undergo NMES five days a week beginning three weeks postoperative and lasting for ten weeks. Both the control and intervention groups will start standard physical therapy six weeks postoperative. Primary outcome measure will be the isometric strength of the gastrocnemius muscle. The secondary outcomes will comprise subjective clinical evaluations (using the Lower Extremity Functional Scale [LEFS]), functional assessments such as the sit-to-stand test, 2-minute walk test, stair climb test and objective clinical evaluation using contralateral comparison of calf circumference.

NCT ID: NCT06338566 Not yet recruiting - Ankle Fractures Clinical Trials

Prospective Follow-up of the Results of Nail Arthrodesis of the Ankle

PROCLOU
Start date: March 2024
Phase:
Study type: Observational

The goal of this prospective, single-center observational study is to describe the functional outcome of the surgical procedure in patient who undergone transplanted centromedullary nailing in the septic setting. Patients will be asked to complete a questionnaire during follow-up consultations.

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: 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: 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: 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: 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: 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: NCT05322564 Not yet recruiting - Surgery Clinical Trials

Standardization of Post-operative Opiate Prescriptions for Same-day Ankle and Wrist Fracture Surgeries

Start date: May 2022
Phase: N/A
Study type: Interventional

The purpose of this prospective cohort study is to evaluate the opiate prescribing patterns post open reduction and internal fixation (ORIF) of wrist and ankle fractures at the Ottawa Hospital. The primary objective would be to examine the quantity and duration of opiates consumed by the study population, as well as the participant's overall satisfaction with pain control. the investigators will assess whether there is a discrepancy between the quantity of pills prescribed and what is being consumed. With the data collected, the secondary objective would be to create a standardized pain prescription, which the investigators would implement in the second phase of this prospective study. Opiate pills consumed, pain satisfaction and left-over narcotics would again be assessed. The overall goal of this study is to produce an appropriate standardized post-operative prescription, where the number of opiates prescribed mirrors what is being consumed. This would cut down on the quantity of left-over narcotics, helping to reduce the incidence of opiate dependency and diversion in the Ottawa community.