[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Major Extremity Trauma Research Consortium\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":198},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,49,75,101,124,146,171],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100492978","phase-3-po-vs-iv-antibiotics-for-the-treatment-of-infected-nonunion-of-fractures-after-fixation-100492978",false,"NCT05699174","PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation","PO Versus IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation","POvIV2","Inclusion Criteria:\n\n1. 1\\. Bone fracture (proximal to and including the tarsal\u002Fmetatarsal joint (Lisfranc) or proximal to the carpal joints (includes distal radius fractures), excluding pelvis and spine) that has previously undergone fixation and has not healed and requires fixation to be retained or replaced at least until bone union. Fractures that have not healed and require revision fixation are also eligible.\n2. Infection as determined by either\n\n   1. FRI criteria\n   2. CDC criteria (without the timeframe) This includes the possibility of culture negative, but determined to be infection by treating surgeon\n3. Systemic antibiotic treatment regimen scheduled for at least 6 weeks\n\nExclusion Criteria:\n\n1. Patients with a high risk of amputation based on the initial managing physician\n2. Patients undergoing treatment of any other investigational therapy within the month preceding infection treatment or planned within the 12 months following infection treatment\n3. Incarcerated or institutionalized patients\n4. Patients who are unable to return for required follow-up visits and\u002For medical co-morbidities which preclude treatment with a general anesthetic\n5. Patients with a prior history of chronic infection at the index site before fracture fixation\n6. Patients with pathological fractures from a neoplastic process\n7. History of Paget's Disease\n8. The patient, or a designated proxy, unwilling to provide consent\n9. The patient must be available for follow-up for at least 12 months following infection treatment","ALL","18 Years",{"count":20,"type":21},250,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.",[27,28,29,30,31,32,33,34,35],"Infections","Infected Wound","Nonunion of Fracture","Injury Leg","Amputation","Internal Fixation; Complications, Infection or Inflammation","Fracture","Lower Extremity Fracture","Antibiotic Side Effect","RECRUITING","2026-06-09",{"date":39,"type":40},"2026-06-11","ACTUAL",{"date":42,"type":40},"2023-05-30",{"date":44,"type":21},"2028-09-29",{"name":46,"class":47},"Major Extremity Trauma Research Consortium","OTHER",13,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100414556","phase-3-evaluation-of-a-new-strategy-for-protocolized-antibiotic-care-for-severe-open-fractures-sextant-100414556","NCT04678154","Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT","Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT - A Multicenter Randomized Control Trial","Inclusion Criteria:\n\n1. Injury meeting at least one of the following criteria:\n\n   * Gustilo type III tibia (OTA 41 plateau, OTA 42 shaft and OTA 43 pilon) requiring a second procedure for final debridement and definitive coverage \u002F closure following the index stabilization\n   * Gustilo type IIIB ankle fractures (OTA 44)\n   * Gustilo type IIIB calcaneus fractures (OTA 82)\n   * Gustilo type IIIB talus fractures (OTA 81)\n   * Traumatic \"zone-of-injury\" trans-tibial amputations requiring DPC, and\u002For flap coverage\n2. Ages 18 - 64 years inclusive\n3. Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.\n4. Patients may have a traumatic brain injury.\n5. Patients may have other fractures including spine, upper extremity fractures, contralateral lower extremity injuries, ipsilateral pelvis, hip, femur or foot injuries.\n6. Patients may be treated initially at an outside institution prior to transfer to the study institution, as long as the definitive wound closure or coverage was not performed prior to entrance into the study.\n7. Patients with bilateral injuries that meet inclusion criteria may be included, but only the limb rated as \"more severe\" by the treating surgeon will be enrolled in the study.\n8. Patients may have co-existing non-tibial or hindfoot infection, with or without antibiotic treatment.\n9. Patients may be definitively stabilized using any method (nail, plate, ex fix or cast).\n10. Patients may have a fasciotomy.\n\nExclusion Criteria:\n\n1. Patient in current therapy for a wound, implant or fracture site infection related to the study site.\n2. Patient likely to have difficulty maintaining follow-up, including:\n\n   * Diagnosis of a severe psychiatric condition\n   * Intellectually challenged without adequate family support\n   * Resides outside of the hospital's catchment area\n   * Planning to follow-up at another medical center\n   * Being a prisoner\n   * Not having a means of contact (address, cell phone, home phone, e-mail)","64 Years",{"count":58,"type":21},1200,[24],"The proposed study is a multi-center, prospective randomized controlled trial comparing current standard of care treatment to the SEXTANT treatment protocol in patients with Type III open fractures of the tibia and IIIB fractures of the ankle and hindfoot.",[62],"Post Operative Surgical Site Infection",[64,65],"Surgical site infection risk prevention","Bacterial species type and antibacterial sensitivities","2026-05-21",{"date":68,"type":40},"2026-05-26",{"date":70,"type":40},"2021-05-07",{"date":72,"type":21},"2027-03-31",{"name":46,"class":47},31,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100542009","phase-3-incisional-negative-pressure-wound-therapy-to-reduce-infection-and-complications-in-high-risk-fractures-100542009","NCT06337292","Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures","Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures: A Multicenter Randomized Controlled Trial","iVAC","Inclusion Criteria:\n\n1. All open or closed tibial plateau or pilon fractures treated operatively with internal fixation at high risk for complication. Any open Gustilo Type I, II or IIIA tibial shaft fracture treated definitively with internal or external fixation with or without ipsilateral leg compartment syndrome if at least one wound is primarily closed.\n2. We define high-risk fractures as those that are either:\n\n   * Closed fracture initially treated with an external fixator (with or without limited internal fixation) and treated definitive more than 3 days later after swelling has resolved;\n   * Any open type I, II or IIIA fracture, regardless of timing of definitive treatment;\n   * Any tibial plateau fracture associated with ipsilateral leg compartment syndrome fasciotomy wounds that has at least one wound primarily closed\n3. Requiring incision for fixation or debridement of 3 cm or greater.\n4. Patients 18 years of age or older\n\nExclusion Criteria:\n\n1. The study injury is already infected at time of study enrollment.\n2. Patient is unable to receive incisional NPWT for any reason.\n3. Patients who have already had definitive fixation prior to enrollment in the study.\n4. Severe problems with maintaining follow-up (e.g., patients who are homeless at the time of injury or those who are intellectually challenged without adequate family support or who are prisoners).\n5. The study injury is a Gustilo Type IIIB or IIIC open fracture.",{"count":84,"type":21},352,[24],"This is a multi-center, pragmatic, parallel arm randomized controlled trial (RCT) of 352 patients with high-risk open or closed tibial plateau fracture, high-risk open or closed tibial pilon fracture, or open tibial shaft fracture with incision \\>3cm. Eligible participants will be randomized to receive either incisional negative pressure wound therapy (NPWT) or a non-suction standard-of-care wound dressing for their definitive wound management. The primary outcome will be a composite outcome to evaluate clinical status 3 months after randomization.",[88,89,28,90,91],"Fracture of Tibia","Wound Heal","Wound Complication","Wound Dehiscence","2026-05-07",{"date":94,"type":40},"2026-05-12",{"date":96,"type":40},"2025-01-01",{"date":98,"type":21},"2028-12-31",{"name":46,"class":47},6,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":5},"100423069","phase-2-evaluating-the-safety-and-efficacy-of-polyethylene-glycol-peg-mediated-fusion-peg-fusion-100423069","NCT04789044","Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)","A Phase 2a Multicenter Randomized Controlled Trial Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion) Compared to Standard of Care in the Repair of Mixed Motor-sensory Acute Peripheral Nerve Injuries (PNI) for Rapid and Immediate Improvement in Outcome","Inclusion Criteria:\n\n1. Ages 18-80\n2. Sustained a complete peripheral nerve injury resulting from upper extremity trauma presenting within 48 hours of injury\n3. Involves injury or dysfunction to motor and\u002For sensory function of the axillary, radial, median, ulnar, or musculocutaneous nerve with injury localized between the proximal humerus and the distal flexion crease of the wrist\n4. Involves a \"mixed\" nerve segment (i.e., involves a location of any of the above specified nerves that can be expected to have both sensory and motor axons present).\n\nExclusion Criteria:\n\n1. Patients beginning surgery within hours after injury.\n2. Injury to the brachial plexus nerves\n3. Injury to the nerves distal to the distal flexion crease of the wrist\n4. Injury that involves a distal extension of the parent nerve that is considered sensory only (superficial radial nerve, lateral antebrachial cutaneous nerve, etc.) or the posterior interosseus or anterior interosseus nerve distal to the midpoint of the forearm (i.e., distal to what can be considered the main motor branches of the PIN and AIN).\n5. Previous peripheral nerve injury resulting from trauma, stroke, muscular, neurologic, or neuromuscular disorder\n6. Documented psychiatric disorder that is expected to result in high probability of self-harm or interfere with study follow-up.\n7. Severe problems with maintaining follow up (e.g., patients who are prisoners or homeless at time of injury or who are intellectually challenged without adequate family support).\n8. Not expected to survive the next 30 days due to their injuries\u002Fhealth condition.\n9. The subject has a known allergy to polyethylene glycol (PEG).\n10. If any of the assessments cannot be done on the contralateral side (CL) or the MRCC sensory 2PD value is \\> 10 mm on the CL side during baseline period, the subject is a screen failure.\n11. The subject is pregnant and\u002For is breastfeeding.\n12. The subject has a significant medical comorbidity precluding immediate repair.\n13. The subject is not able to strictly adhere to the rules of the current clinical protocol.","80 Years",{"count":110,"type":21},40,[112],"PHASE2","The overall objective of this study is to determine the safety of PEG fusion when used with primary repair or reconstruction in patients with an acute upper extremity peripheral nerve injury. PEG is safe and effective for extending the half-life of circulating pharmaceutical products, when used in conjunction with a topical hemostatic agent in surgical wounds, and when used as a colon cleanser for endoscopic surgical procedures. However, PEG fusion has not been rigorously tested as a safe reagent to promote nerve regeneration in humans. Therefore, the goal of this Phase 2a clinical trial is to establish safety data and to examine the effect of PEG fusion on clinical outcomes including recovery of sensory and motor function. Results will be externally validated using data collected in the DoD funded prospective NERVE study and will provide preliminary evidence to power a larger phase II efficacy trial.",[115],"Peripheral Nerve Injuries","2026-02-25",{"date":118,"type":40},"2026-02-27",{"date":120,"type":40},"2023-06-01",{"date":122,"type":21},"2028-10-01",{"name":46,"class":47},{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100426937","phase-2-multicenter-trial-evaluating-the-safety-and-efficacy-of-autologous-volar-fibroblast-injection-into-the-terminal-limb-of-amputees-100426937","NCT04839497","Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees.","A Phase 2 Multicenter Randomized Single Arm Crossover Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees","Inclusion criteria:\n\n1. Ages 18 to 75, inclusive\n2. Must have a transtibial amputation\n3. Must be using a prosthesis within the vicinity of 3 months or have had osteo-integration of a prosthetic in place for 1 month\n4. In the opinion of the investigator, must be medically able to undergo the administration of study material determined by laboratory tests obtained up to 14 days before baseline for which the investigator identified no clinically significant abnormality.\n5. Able to provide written informed consent\n6. Females of childbearing potential must: have a negative pregnancy test at screening agree to not become pregnant or breastfeed for the period of the study through 1 month after completion of the study be willing to use a reliable form of contraception during the study.\n7. Has healthy skin on the residual limb and is free of severe and active skin disease (excluding those on the residual limb) such as extreme and active eczema or psoriasis, active non-healing wounds, lichen planus, a history of keloid scare formation or lupus as determined by the investigator or study nurse.\n8. Willing and able to comply with the scheduled visits, biopsy\u002Finjection procedures, wound care instructions treatment plan, and other study procedures for the duration of the study.\n\nExclusion criteria:\n\n1. A skin erosion deeper than the skin dermis.\n2. Ulcers exceeding 4cm in diameter or 2cm in radius\n3. Non circular ulcers that cannot tolerate a 1cm margin at all sides\n4. Having received any investigational drug within 30 days prior to study entry\n5. An allergy history to any study materials including local anesthetic, dimethyl sulfoxide, human albumin, or bovine constituents, hetastarch, or EMLA (lidocaine 2.5% and prilocaine 2.5%).\n6. Pregnant, lactating, or trying to become pregnant\n7. A history of keloid formation\n8. Having a significant medical history that the investigator feels is not safe for study participation (for example, some forms of autoimmune conditions, metastatic cancer, infectious diseases such as HIV, HTLV I\u002FII, Hepatitis B, Hepatitis C).\n9. Autoimmune diseases affecting the skin such as lupus.\n10. Presence of necrotic ischemic tissue on any stump ulcers, and\u002For capillary refill on stump skin of greater than 3 seconds\n11. Active infection of the residual limb (e.g. osteomyelitis, wound or skin condition with surrounding swelling, erythema, drainage, pain, gangrenous tissue or fever).\n12. Active smoker during the study (this includes e cigarettes and any type of tobacco use)\n13. We will also exclude those who are on chronic immunosuppressive therapies such as oral steroids, but also those on chronic topical steroids in the area of investigation.\n14. Amputees with symptomatic neuromas of the terminal limb within the last 3 months.\n15. Known bleeding disorder.\n16. Have a history of congenital or idiopathic methemoglobinemia, glucose-6-phosphate deficiencies, or use of medications associated with drug-induced methemoglobinemia. (specifically: Sulfonamides, Acetaminophen, Acetanilid, Aniline dyes, Benzocaine, Chloroquine, Dapsone, Naphthalene, Nitrates and Nitrites, Nitrofurantoin, Nitroglycerin, Nitroprusside, Pamaquine, Paraaminosalicylic acid, Phenacetin, Phenobarbital, Phenytoin, Primaquine, or Quinine.)\n17. Quadriplegics","75 Years",{"count":133,"type":21},20,[112],"The study will enroll 20 adults ages 18-75 with a transtibial amputation with mature residual limbs who are ambulatory prosthesis users. Participants will be randomized to either treatment with low dose volar fibroblast injections (n=10) or to vehicle control (n=10). Participants will undergo a biopsy to harvest volar skin for fibroblast expansion and tattooing to identify injection sites on the residual limb. Fibroblasts will be processed at the Hopkins Cellular Therapy Core Lab and volar cells primed for injection will be sent to participating centers for administration. Participants randomized to the treatment group will be treated with low-dose cells. Injections will be administered on at least 1 and up to three separate days over the course of one week. Participants randomized to the vehicle control group will receive injection of cryoprotectant. All participants will be followed at 2 weeks, 1, 2, and 3 months after the last injection. These visits will include a clinical evaluation for complications, non-invasive assessments of skin firmness and thickness, skin appearance, and patient-reported outcomes. After the final monitoring visit, individuals randomized to the vehicle control group will have the opportunity to receive the volar fibroblast injections and will be followed for an additional 3 months.\n\nThe investigators hypothesize that (1) There will be no difference in the rate of serious adverse events among patients treated with volar fibroblast injections compared with patients treated with vehicle control, and (2) Patients treated with volar fibroblast injections will have firmer skin on the residual limb compared with patients tread with vehicle alone.",[31],"2025-10-10",{"date":139,"type":40},"2025-10-14",{"date":141,"type":40},"2022-09-26",{"date":143,"type":21},"2027-01-01",{"name":46,"class":47},1,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},"100507605","evaluation-of-the-diagnostic-and-therapeutic-value-of-tissue-ultrafiltration-in-patients-at-risk-of-acute-compartment-syndrome-acs-100507605","NCT05889559","Evaluation of the Diagnostic and Therapeutic Value of Tissue Ultrafiltration in Patients at Risk of Acute Compartment Syndrome (ACS)","INCLUSION CRITERIA The target population for this study include adults ages 18-60 with high-energy injuries of the upper leg considered at risk for ACS at time of admission by virtue of their mechanism of injury, fracture pattern, clinical signs, or need to undergo fracture fixation surgery (internal or external fixation) within 48 hours of admission. Recruitment of participants will happen during hospital admission for treatment of injury.\n\nEligible patients must meet all of the following criteria and be enrolled during one of two possible times: within 14 hours of injury, or prior to undergoing surgical intervention (internal or external fixation on the injured limb) within 48 hours of admission. Eligible patients will be:\n\n1. Between the ages of 18 and 60 years\n2. Have sustained a high-energy upper leg injury such as open or closed proximal tibial shaft fracture with displacement, comminution, or segmental pattern; proximal fibula fracture; bicondylar tibial plateau fracture; Schatzker IV medial knee fracture-dislocation; proximal leg injury due to shotgun, rifle, or other projectile, or severe crushing injury.\n3. Patient can be enrolled in the study and study procedures initiated within 14 hours of injury,\\* or be enrolled prior to undergoing urgent surgical intervention on the injured limb (defined as internal or external fixation) within 48 hours of admission.\n4. Patient (or authorized legal representative) willing to sign informed consent.\n\n   * If a patient has an eligible injury and is going to surgery within 2 hours (except for fasciotomy - which is an exclusion criteria), the patient can be enrolled and the study procedures initiated at the end of surgery. If an eligible patient is enrolled and there is no surgery anticipated within 2 hours, initiate study procedures immediately.\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Patients not willing to participate\n2. Patients with non-traumatic cases of acute compartment syndrome (e.g. severe exertion, snakebite, high-pressure injection injury)\n3. Patients diagnosed with ACS or impending ACS such that immediate fasciotomy is recommended\n4. Soft tissue wounds, including lacerations or abrasions, that are in a location that will interfere with safe insertion of indwelling pressure or TUF catheters (anterior - anterolateral aspect of the leg)\n5. Patients not likely to follow-up (are homeless, incarcerated, live out-of-state).\n6. Patients with known peripheral vascular disease\n7. Non-ambulatory due to an associated complete spinal cord injury; Non-ambulatory before the injury due to a pre-existing condition.\n8. Very low clinical concern for ACS at time of admission.","60 Years",{"count":154,"type":21},60,[156],"NA","The goal of this clinical trial is to learn if tissue ultrafiltration (TUF) catheters can reduce intramuscular pressure and prevent acute compartment syndrome (ACS) in adults ages 18-60 with severe proximal tibia or tibial shaft fractures.\n\nThe main questions it aims to answer are:\n\nWill intramuscular pressure (IMP) be lower in the TUF cohort compared to controls?\n\nWill the consensus likelihood of ACS, incidence of fasciotomy, and 6-month functional outcomes be better in the TUF cohort?\n\nAre interstitial fluid biomarkers predictive of ACS?\n\nResearchers will compare patients randomized to TUF catheters (n=30) versus control patients receiving standard-of-care only (n=30) to see if TUF lowers ACS risk and improves recovery.\n\nParticipants will:\n\nBe enrolled within 14 hours of injury or prior to high-risk surgery within 48 hours.\n\nReceive continuous anterior compartment pressure monitoring.\n\nUndergo standard-of-care clinical evaluation and treatment.\n\n(TUF arm only) Have three TUF catheters placed in the injured limb to remove interstitial fluid.\n\nReturn for a 6-month follow-up to assess complications, healing, muscle function, and patient-reported outcomes.\n\n(Hennepin Healthcare subset) Provide interstitial fluid samples for biomarker analysis.",[159,160,161],"Acute Compartment Syndrome","Fracture, Bone","Tibial Fractures","2025-08-21",{"date":164,"type":40},"2025-08-28",{"date":166,"type":40},"2024-01-01",{"date":168,"type":21},"2026-07-01",{"name":46,"class":47},4,{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":108,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},"100593456","phase-3-effect-of-nsaids-on-union-opioid-utilization-and-pain-management-for-tibia-fractures-a-pragmatic-randomized-controlled-trial-100593456","NCT07006675","Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial","NSAID","Inclusion Criteria:\n\n1. All patients with open (Grade I, II, of IIIa) or closed tibia fractures treated with a nail.\n2. Patients 18-80 years old inclusive.\n3. Patients able to be followed at a METRC facility for at least 12 months following injury\n\nExclusion Criteria:\n\n1. Patient unable to provide informed consent\n2. Patients who are current - intravenous drug user.\n3. Patients with a history of allergy to the study drugs.\n4. Patients unable to swallow oral medications or without functioning GI tract.\n5. Patients with a history of gastrointestinal bleeds or gastric perforation.\n6. Patients with a history of stroke or heart attack.\n7. Patients requiring an aspirin or NSAID regimen except for low dose aspirin, 81mg.\n8. Patients with any bleeding disorders.\n9. Patients with severe renal failure \\[GFR:\\\u003C30\\]. Patients with moderate renal failure \\[GFR: 30-59\\] may participate in the study at a modified dose \\[see section 8.6 for defined modified dose\\].\n10. Patients undergoing daily treatment with systemic glucocorticoids before surgery.\n11. Patients likely to have severe problems maintaining follow-up, including patients diagnosed with a severe psychiatric conditions, patients who live too far outside the hospital's catchment area, patients who are incarcerated and patients who have unstable housing situations.\n12. Patients with a GCS \\\u003C15 at discharge.\n13. Patients with a closed head injury that precludes NSAIDS.\n14. Patients who are pregnant or lactating at time of screening\n15. Patients with a bone graft procedure planned for a future date at the time of initial definitive fixation surgery.",{"count":179,"type":21},1000,[24],"Two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial evaluating the efficacy of standard pain management without NSAIDs (Group 1) vs. standard pain management plus up to 6 weeks of NSAIDs (Group 2) in the treatment of tibial shaft fractures.",[161,183],"Pain",[185,186,187,188,176],"Ibuprofen","Pain Management","Tibia Fracture","IM Nail Fixation","2025-05-27",{"date":191,"type":40},"2025-06-05",{"date":193,"type":40},"2021-05-26",{"date":195,"type":21},"2027-03",{"name":46,"class":47},14,""]