[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"orthopaedic-trauma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:orthopaedic-trauma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,72,110],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100515263","emotional-awareness-and-expression-therapy-for-people-with-persistent-pain-following-orthopedic-trauma-100515263",false,"NCT05989230","Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma","Emotional Awareness and Expression Therapy for People With Persistent Pain Following Orthopedic Trauma: A Pilot Feasibility Study","Inclusion Criteria:\n\n* One or more acute orthopedic injuries\n* The patient sustained an orthopedic injury including, but not limited to:\n\n  * Pelvic or acetabulum fracture\n  * Open\u002Fdisplaced comminuted fracture of long bones\n  * Upper extremity injuries with a major nerve involvement\n  * Injuries with significant injuries to major blood vessels\n  * Traumatic amputation of big toe, thumb, or proximal to the wrist or ankle.\n* Initial admission to the trauma or orthopedic center\u002Fservice of the participating hospital OR all necessary screening and patient characteristic data available in medical record (determination based on information available at time of enrollment)\n* 18 years old or older\n* Received operative fixation for at least one acute orthopaedic injury at a participating hospital. Patients should be recruited at the time of primary injury, not revision or complication surgery\n* Average Brief Pain Inventory Score \\> 3\u002F10\n* Presence of pain most days (\\> 3 days\u002Fweek) for past three months\n\nExclusion Criteria:\n\n* peri-prosthetic fractures of the femur (regardless of etiology)\n* non-ambulatory due to an associated spinal cord injury\n* non-ambulatory pre-injury\n* currently pregnant\n* moderate or severe traumatic brain injury (TBI), as evidenced by intracranial hemorrhage present on admission CT\n* major amputation(s) of the upper or lower extremities\n* non-English speaking\n* Likely to have severe problems with maintaining follow-up for any of the following reasons:\n\n  * The patient has been diagnosed with a severe psychiatric conditions\n  * The patient has current alcohol and\u002For drug addiction based on medical record or patient self-report.\n  * The patient is intellectually challenged without adequate family support\n  * The patient lives outside the hospital's catchment area\n  * The patient follow-up is planned at another medical center\n  * The patient is a prisoner\n  * The patient is homeless\n  * Other","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this single-arm trial is to determine the feasibility of emotional awareness and expression therapy (EAET) for individuals with persistent pain following orthopedic trauma. As part of this study, participants will be asked to attend weekly EAET treatment sessions and complete assessments (including pre-treatment, post-treatment, and follow-up) consisting of questionnaires and sensory testing procedures.",[26,27,28],"Orthopaedic Trauma","Chronic Pain","Musculoskeletal Injury","RECRUITING","2026-06-17",{"date":32,"type":33},"2026-06-18","ACTUAL",{"date":35,"type":33},"2024-08-28",{"date":37,"type":20},"2027-09-01",{"name":39,"class":40},"Johns Hopkins University","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100531582","phase-4-low-dose-short-term-ketorolac-to-reduce-chronic-opioid-use-in-orthopaedic-polytrauma-patients-100531582","NCT06201676","Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients","Inclusion Criteria:\n\n* Patient age: 18-70\n* Patient or legally authorized representative (LAR) able to provide consent\n* Patients with acute musculoskeletal trauma requiring surgical fixation (i.e. ORIF with plates and screws and\u002For intramedullary nailing)\n* Anticipated hospital admission\n* Patients who speak English or Spanish\n* Patients who can be followed at the enrolling facility for at least 6 months\n\nExclusion Criteria:\n\n* Patient age \\\u003C 18 or \\> 70 years\n* Patients with injury more than 24 hours prior to evaluation\n* Patients with active hemorrhagic shock or risk of significant hemorrhage\n* Patients who are pregnant or breastfeeding\n* Patients with a history of active gastrointestinal bleeds or ulceration\n* Patients with chronic use of steroids or immune-modulating drugs or history of organ transplantation\n* Patients with preexisting chronic renal, liver, heart, or lung disease\n* Patients with a creatinine ≥ 1.30 mg\u002FdL during enrollment\n* Patients with history of myocardial infarction, stroke, or bleeding disorder\n* Patients with head or chest injury requiring surgical intervention\n* Patients with allergy to ketorolac or hypersensitivity to aspirin\n* Patients receiving chronic opioid therapy or treatment for opioid use disorder\n* Patients who are current IV drug users\n* Patients who require a daily NSAID or aspirin regimen, except for daily low-dose aspirin (81 mg)\n* Patients with insufficient follow-up or anticipated difficulty in completing follow-up at a study site for a minimum of 6 months due to any of the follow reasons: death, no follow-up after initial discharge, severe psychiatric conditions, unstable living conditions, planned follow-up at another medical center not participating in this study, live far away from the clinic, and\u002For incarcerated","70 Years",{"count":50,"type":20},458,[52],"PHASE4","The goal of this randomized clinical trial is to learn if the use of a low-dose nonsteroidal anti-inflammatory drug (NSAID), ketorolac, reduces the rate of chronic opioid use in orthopaedic trauma patients. The main questions this study aims to answer are:\n\n1. Are patients who are given scheduled ketorolac during the first five days of the perioperative period in combination with standard of care (SOC) multimodal analgesia (MMA) less likely to develop chronic opioid use at 6 months after injury compared to patients who SOC MMA alone?\n2. Does scheduled ketorolac during the first five days of the perioperative period improve functional responses to pain at discharge, 3 months, and 6 months after injury?\n3. Does early pain control provided by ketorolac decrease chronic opioid use through decreased acute pain and opioid use, improved functional responses to pain, or both?\n\nParticipants will be enrolled and randomized to either the ketorolac (treatment) group or the SOC group. Patients randomized to the ketorolac group will receive ketorolac every 6 hours for up to five days during the perioperative period; patients discharged prior to completing the five-day regimen will complete the remainder of treatment with oral ketorolac. Pain and opioid use will be measured daily during the five-day treatment period. Opioid use will be measured and functional response to pain surveys will be obtained at discharge, 2 weeks, 6 weeks, 3 months, and 6 months after injury.\n\nResearchers will compare patients receiving ketorolac (treatment) plus SOC versus those receiving SOC alone to determine if ketorolac reduces chronic opioid use and improves the functional response to pain.",[26,55],"Chronic Opioid Use",[57,58,59,60,61],"orthopaedic trauma","chronic opioid use","NSAID","IV ketorolac","acute pain management","2026-05-13",{"date":64,"type":33},"2026-05-14",{"date":66,"type":33},"2025-02-28",{"date":68,"type":20},"2027-08-31",{"name":70,"class":40},"Massachusetts General Hospital",2,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":93,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":41},"100630348","mindfulness-in-fracture-recovery-and-reduction-of-opioid-reliance-evaluating-the-feasibility-of-implementing-a-brief-mindfulness-based-intervention-to-manage-pain-and-anxiety-before-and-after-fracture-surgery-100630348","NCT07486505","Mindfulness in Fracture Recovery and Reduction of Opioid Reliance: Evaluating the Feasibility of Implementing a Brief, Mindfulness-based Intervention to Manage Pain and Anxiety Before and After Fracture Surgery","Mindfulness in Fracture Recovery and Reduction of Opioid Reliance (MIRROR): Evaluating the Feasibility of Implementing a Brief, Mindfulness-based Intervention to Manage Pain and Anxiety Before and After Fracture Surgery","MIRROR","The inclusion criteria are:\n\n1. Adults 18 years of age or older; and\n2. Presenting to the hospital with an open or closed appendicular fracture requiring internal fixation. Patients with multiple fractures may be included.\n\nThe exclusion criteria are:\n\n1. Does not have the English-language skills required to participate in trial interventions (in the judgement of site research personnel);\n2. Cognitive impairment (including traumatic brain injury);\n3. Auditory or visual impairment that would inhibit ability to receive intervention;\n4. Current incarceration;\n5. Concomitant injury which, in the opinion of the attending surgeon, is likely to impair function for as long as or longer than the patient's extremity fracture;\n6. Previously completed a standardized mindfulness program (e.g., MBSR) or regularly (e.g., daily) practice mindfulness;\n7. Active psychosis;\n8. Active suicidality;\n9. Stress fracture;\n10. Fragility fracture;\n11. Currently enrolled in a study that does not permit co-enrolment in other trials;\n12. Not willing to participate in the intervention;\n13. No provision of informed consent; or\n14. Other reason as approved by the Data Coordinating Centre.",{"count":81,"type":20},50,[23],"Breaking a bone is not only physically painful but also emotionally overwhelming. Patients often experience intense pain, anxiety, and uncertainty as they are rushed to hospital, undergo emergency treatment, and prepare for surgery. After surgery, many continue to struggle with pain and rely on opioid medications, which carry serious risks including addiction. In the context of our current opioid epidemic, it's critical that alternative treatment strategies are urgently evaluated.\n\nMindfulness is a practice that helps people focus on the present and has been shown to reduce stress and pain in other settings. In this trial, patients with broken arms or legs who need surgery at Hamilton General Hospital will be randomly assigned to one of two groups who will listen to a two-part, audio recording before and after surgery. Those in the interventional group will engage in a 7-minute audio-guided mindfulness exercise before surgery to help reduce anxiety, and another 7-minute audio-guided mindfulness exercise after surgery to help manage pain. Those in the control group will listen to a 7-minute educational audio recording before surgery and again after surgery.\n\nThe main goal is to see if this approach is practical-can enough patients be recruited, and will they complete the audio recordings? The study will also look at early signs of whether the intervention helps reduce pain, anxiety, and opioid use six weeks after surgery. If feasible, a larger study can be conducted to determine if these exercises can help patients manage pain and reduce their need for opioids after surgery.\n\nIf successful, this simple, low-cost approach could be widely used in hospitals to support recovery and reduce reliance on pain medications.",[85,86,26,87,88,89,90,91,92],"Orthopaedic Fractures","Orthopaedic Trauma Fractures and Non-unions","Orthopaedic Surgery","Orthopaedic Related Pain (Musculoskeletal Pain)","Anxiety Acute","Anxiety After Surgery","Opioid Use","Opioid Use After Surgery",[94,95,96,97,98,99],"fractures","mindfulness","pain management","fracture surgery","opioid use","anxiety","NOT_YET_RECRUITING","2026-04-06",{"date":103,"type":33},"2026-04-07",{"date":105,"type":20},"2026-05-01",{"date":107,"type":20},"2026-10-30",{"name":109,"class":40},"McMaster University",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":117,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":121,"conditions":122,"keywords":126,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":41},"100609672","phase-4-pre-incision-peripheral-nerve-blocks-for-lower-extremity-fracture-surgery-in-older-adults-100609672","NCT07217626","Pre-Incision Peripheral Nerve Blocks for Lower Extremity Fracture Surgery in Older Adults","Pre-Incision Peripheral Nerve Blocks Versus No Peripheral Nerve Blocks for Lower Extremity Fracture Surgery in Older Adults: A Pilot Feasibility Study","Inclusion Criteria:\n\n1. Age ≥50 years\n2. Isolated fractures\n3. Radiographically confirmed lower extremity fracture requiring surgical fixation including:\n\n   1. Femoral shaft\n   2. Distal femur\n   3. Patella\n   4. Proximal tibia\n   5. Tibial shaft\n   6. Distal Tibia\n   7. Pilon fractures\n   8. Ankle (malleolar fractures)\n   9. Calcaneus\n   10. Talus\n   11. Hindfoot\u002Fmidfoot\n4. Acute fracture receiving definitive fixation during injury hospitalization\n\n4\\) Ability to provide informed consent (patient or legally authorized representative (LAR))\n\nExclusion Criteria:\n\n1. Contraindication to peripheral nerve block\n\n   1. Infection at planned needle insertion site\n   2. Patient refusal\n   3. Surgeon or anesthesiologist refusal secondary to the patient's medical status\n2. Active peripheral nerve blockade from initial injury analgesic management is defined as:\n\n   a. Risk of local anesthetic systemic toxicity\n3. Neurologic or vascular injuries in the affected limb\n4. Polytrauma with traumatic brain injury\n5. Thoracic injury and\u002For abdominal injury requiring surgical intervention\n6. Current enrollment in a conflicting clinical trial\n7. Acute or Subacute residence prior to injury\n8. Incarcerated at the time of enrollment\n9. Prior enrollment in this trial\n10. Unable to obtain informed consent due to language barrier\n11. Unable to obtain informed consent because a legally authorized representative was unavailable.\n12. Anticipated problems with follow-up compliance","50 Years",{"count":119,"type":20},34,[52],"Fractures of the lower leg are especially difficult for older adults. They are more likely to have serious complications, require longer healing times, and have a higher risk of death This occurs because their bodies cannot tolerate stress as well as younger individuals. The injury itself places significant strain on the body, and surgery adds additional stress.\n\nAnesthesiologists use nerve blocks to help manage pain during and after these injuries. A nerve block is an injection that numbs the fracture and surgery area by blocking pain signals. These injections help patients need fewer opioid medications. However, new research shows these nerve blocks may provide benefits beyond pain management. Studies looking at older adults with hip fractures who received nerve blocks showed better overall outcomes: fewer deaths, fewer serious complications, and shorter hospital stays.\n\nHowever, it is not currently known if nerve blocks work this well for other broken bones in the leg, like in the thigh or shin. Additional research is need to know if nerve blocks can help patients with all types of leg fractures recover faster and experience fewer problems.\n\nBefore the investigators start a large clinical trial, a small pilot study needs to be completed to determine if a larger clinical trial is feasible. This pilot study will evaluate the ability to recruit enough patients, ensure patients can receive the assigned treatment, collect data effectively, follow the study protocol, and track participants over time. The results will indicate whether the investigators are prepared to proceed with a full-scale trial and help refine the approach.",[123,124,26,125],"Lower Extremity Fracture","Surgical Fracture Repair","Orthogeriatric Fractures",[127,128,129,130,131,132,125,133],"Regional Anesthesia","Clinical Outcomes","Orthopaedic trauma","Perioperative Outcomes","Pilot Study","Lower Extremity Fractures","Peripheral Nerve Blocks","2026-03-25",{"date":136,"type":33},"2026-03-30",{"date":138,"type":33},"2026-02-24",{"date":140,"type":20},"2026-12-31",{"name":142,"class":40},"University of Maryland, Baltimore"]