[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pilon-fracture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pilon-fracture":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100460823","simplified-post-op-rehabilitation-for-ankle-and-pilon-fractures-100460823",false,"NCT05280639","Simplified Post Op Rehabilitation for Ankle and Pilon Fractures","Ankle and Pilon Fracture Post Operative Rehabilitation: A Randomized Control Trial Exploring a Simplified Wooden Block Protocol","Inclusion Criteria:\n\n* Ages 18-65\n* Surgically treated open or closed fractures of the ankle or tibial plafond\n\nExclusion Criteria:\n\n* Contralateral lower extremity injuries that would limit weight bearing after 6 weeks\n* Severe injury requiring flap coverage or vascular reconstruction (Gustilo-Anderson Type IIIB and C respectively)\n* Neurological deficits that would impede ability to stand safely unassisted for home exercise regiment\n* Desire to participate in formal physical therapy program\n* Additional injury that would compromise subjects ability to follow either Home Exercise Program\n* Non ambulatory prior to injury\n* Previous ankle or tibial plafond injury on ipsilateral extremity\n* BMI \\> 50\n* Severe problems maintaining follow up\n* Previous ankle\u002Ftibial plafond fracture\n* Prisoners\n* Neurological impairments that impair balance","ALL","18 Years","65 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","The aim of this study is to compare standard post operative rehabilitation with a simplified wooden block stretching protocol that will yield similar results.",[27,28],"Ankle Fractures","Pilon Fracture","RECRUITING","2026-06-05",{"date":32,"type":33},"2026-06-08","ACTUAL",{"date":35,"type":33},"2022-10-03",{"date":37,"type":21},"2027-06-01",{"name":39,"class":40},"University of Virginia","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":41},"100335848","phase-4-pilon-fracture-with-intra-articular-injection-of-n-acetylcysteine-pilon-nac-100335848","NCT03652753","Pilon Fracture With Intra-articular Injection of N-Acetylcysteine (Pilon NAC)","Prevention of Cartilage Cell Death Following a Pilon Fracture With Intra-articular Injection of N-Acetylcysteine (Pilon NAC)","Inclusion Criteria:\n\n* Closed high energy pilon fracture requiring a staged procedure\n\nExclusion Criteria:\n\n* Younger than 18\n* Open fracture\n* Intra-articular injury not requiring a staged procedure\n* Allergy to NAC\n* Wounds preventing safe intra-articular injection\n* Unwilling to participate in the study\n* Pregnancy",{"count":20,"type":21},[51],"PHASE4","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.\n\nThe 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.",[28],"2026-04-23",{"date":56,"type":33},"2026-04-28",{"date":58,"type":33},"2019-01-01",{"date":60,"type":21},"2026-12",{"name":62,"class":40},"University of Missouri-Columbia",{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":71,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":75,"conditions":76,"keywords":77,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":41},"100449349","frame-study-frailty-related-ankle-fracture-management-and-evaluation-100449349","NCT05131321","FRAME Study (Frailty-Related Ankle Fracture Management and Evaluation)","FRAME Study (Frailty-Related Ankle Fracture Management and Evaluation): Retrograde Nailing Versus Open Reduction and Internal Fixation for Unstable Fractures Around the Ankle in the Frail Elderly - A Two-Part Prospective, Randomized, Multi-Center Clinical Trial","FRAME","Patient Inclusion Criteria - Both Parts:\n\n(i) Age ≥ 60 years (ii) One or more of the following:\n\n* Severe soft tissue compromise\n* Significant co-morbidities (vascular disease + chronic trophic changes, diabetes + neuropathy, chronic renal failure, morbid obesity (BMI\\> 40))\n* Frailty as defined by a Dalhousie Clinical Frailty Scale score ≥4\n\nPart 1 Specific Inclusion Criteria:\n\n(i) Isolated fracture (within 4 weeks of injury): an AO\u002FOTA type 43C2 or C3 tibial pilon fracture or severe ankle fracture (fracture-dislocation, severe joint impaction, severe trimalleolar)\n\nPart 2 Specific Inclusion Criteria (i) Isolated fracture (within 4 weeks of injury): an AO\u002FOTA type 44B2, B3, C1 or C2 ankle fracture\n\nPatient Exclusion Criteria - Both Parts:\n\n(i) Presence of vascular injury or pathologic fracture; (ii) Previous tibia pilon fracture or retained hardware in affected limb; (iii) Refusal to participate; (iv) Inability to obtain informed consent due to language barrier","40 Years",{"count":73,"type":21},172,"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\n\nThe Investigators have amended the study to include a second part for patients with less complicated but still unstable ankle fractures. In this part, patients will be randomly assigned to receive either a procedure called ORIF or another one called retrograde intramedullary fibular nailing.",[27,28],[78,79,80,81,82,83,84,85],"Complex ankle fracture","Pilon fracture","Primary Ankle Arthrodesis","Fragility fracture","Elderly","Open reduction","Internal fixation","AO\u002FOTA type 44B2, B3, C1 or C2 ankle fracture","2026-01-26",{"date":88,"type":33},"2026-01-28",{"date":90,"type":33},"2022-04-21",{"date":92,"type":21},"2028-12",{"name":94,"class":40},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"]