[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"internal-fixation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:internal-fixation":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,69,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":41,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100634199","time-to-healing-in-displaced-pediatric-diaphyseal-forearm-fractures-treated-with-bioabsorbable-compared-to-titanium-intramedullary-nails-100634199",false,"NCT07536581","Time to Healing in Displaced Pediatric Diaphyseal Forearm Fractures Treated With Bioabsorbable Compared to Titanium Intramedullary Nails","Time to Healing in Displaced Pediatric Diaphyseal Forearm Fractures Treated With Bioabsorbable Compared to Titanium Intramedullary Nails: A Single-Center, Multi-Blinded, Randomized Parallel-Group, Non-Inferiority Study","FOREST","Inclusion Criteria:\n\n* Diagnosis of a traumatic diaphyseal forearm fracture of the radius, ulna, or both\n* Operative fixation required\n* Fractures must be complete (not unicortical or greenstick) AND displaced \\>50% of bone width (after attempted closed reduction) AND\u002FOR angulated \\>10° in any plane (after attempted closed reduction)\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Conditions where internal fixation is contraindicated (e.g. active or potential infection)\n* Grossly open fractures (Gustilo Anderson grade \\> 2)\n* Fracture occurred more than 2 weeks prior\n* Fractures that are well managed conservatively (undisplaced or minimally displaced)\n* Previous ipsilateral forearm fracture (risk of closed medullary canal)\n* Fractures unsuited for intramedullary nailing (e.g. multifragmentary, metaphyseal or epiphyseal)\n* Concurrent ipsilateral wrist or elbow involvement (e.g. Monteggia or Galeazzi variants)\n* Unable to participate in follow-up\n* Existing bone pathology (e.g. tumor, osteogenesis imperfecta, degenerative disease)\n* Participation in any other medical device or medicinal product study within the previous month that could influence in opinion of the PI the results of the present study\n\nIntraoperative exclusion criteria:\n\n* Fractures suitable for closed reduction and casting (see 6.3.9)\n* Indication for treatment 1 (BIN) only\n* Indication for treatment 2 (ESIN) only\n* Intraoperative decision to use implants other than the devices under investigation","ALL","3 Years","13 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study looks at children with forearm fractures that need surgery. The standard treatment uses titanium nails, which usually need to be removed in a second operation later. This study compares titanium nails with bioabsorbable nails, which gradually dissolve in the body and may help some children avoid another operation.\n\nThe study will compare how quickly the fractures heal on X-ray, and also look at complications, recovery, function, and the family's experience. Children who need surgery will be randomly assigned to one of the two treatments so the comparison is fair.\n\nHypothesis: The researchers expect that fractures treated with bioabsorbable nails will heal almost as quickly as fractures treated with titanium nails, while reducing the need for later implant removal surgery.",[28,29,30,31,32,33,34,35,36,37,38,39,40],"Forearm Injuries","Radius Fractures","Ulna Fractures","Fractures, Bone","Child","Adolescent","Fracture Fixation, Intramedullary","Internal Fixation","Orthopedic Operations","Polymers","Fracture Healing","Radiography","Randomized Controlled Trial (RCT)",[40,42,43,44,45,46,47,48,49,50,51,52,53,54,55],"pediatric forearm fracture","forearm shaft fracture in children","elastic stable intramedullary nailingelastic stable intramedullary nailing","ESIN","titanium elastic nail","bioabsorbable intramedullary nail","TEN","BIN","radiographic healing","radiographic union","modified Radiographic Union Score","mRUS","non-inferiority trial","randomized trial","NOT_YET_RECRUITING","2026-04-17",{"date":59,"type":60},"2026-04-22","ACTUAL",{"date":62,"type":22},"2026-04",{"date":64,"type":22},"2031-12",{"name":66,"class":67},"Children's Fractures Interest Group, Denmark","OTHER",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":77,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100554267","early-internal-fixation-versus-nonoperative-care-with-early-rehabilitation-for-lc1-fragility-fractures-of-the-pelvis-100554267","NCT06496867","Early Internal Fixation Versus NonOperative Care With Early Rehabilitation for LC1 Fragility Fractures of the Pelvis","Multicenter Randomized Controlled Trial Comparing Early Internal Fixation Versus NonOperative Care With Early Rehabilitation for LC1 Fragility Fractures of the Pelvis: A Pilot Study","PIVOT-LC1-Pi","Inclusion Criteria:\n\n1. Patient 60 years of age or older.\n2. Low energy injury mechanism defined as a fall from standing height.\n3. LC1 pelvis fracture (AO\u002FOTA 61B1.1 or 61B2.1) confirmed with antero-posterior, inlet, and outlet pelvis radiographs, computed tomography, or magnetic resonance imaging.\n4. Fracture pattern that could be, in the judgment of the attending surgeon, managed with either early internal fixation or nonoperative care with early rehabilitation.\n5. Fracture displacement of \\\u003C10 mm of the posterior pelvic ring on computed tomography of the pelvis.\n6. Injury occurred within 21 days of screening.\n\nExclusion Criteria:\n\n1. Patient did not ambulate prior to injury.\n2. Patient has another condition, injury, or fracture that prevents post-operative weightbearing on any extremity.\n3. Retained implants around the pelvis that precludes or limits either study treatment.\n4. Infection around the hip (soft tissue or bone).\n5. Pathologic fracture with a lytic lesion in the pelvis or sacrum that precludes internal fixation.\n6. Patient is too ill, in the judgement of the attending surgeon, for internal fixation.\n7. Patient is too ill, in the judgement of the attending surgeon, for nonoperative care.\n8. Problems, in the judgment of study personnel, with maintaining follow-up with the patient.\n9. Expected injury survival of less than 12 months.\n10. Terminal illness with expected survival of less than 12 months.\n11. Currently enrolled in a study that does not permit co-enrollment.\n12. Prior enrollment in the trial.\n13. Unable to obtain informed consent due to language barriers.\n14. Unable to obtain informed consent because a legally authorized representative (LAR) was unavailable.\n15. Did not provide informed consent (declined participation).\n16. Patient or LAR not approached to participate in the trial (missed patient).\n17. Other reason to exclude the patient, as approved by the Methods Centre.","60 Years",{"count":79,"type":22},48,[25],"The goal of this randomized pilot study is to assess feasibility of the trial and to collect information to inform the design of a definitive trial. Adult patients ages 60 years or older with a low-energy lateral compression type 1 (LC1) pelvis fracture with \\\u003C10 mm initial displacement of the posterior pelvic ring will be eligible to participate in the study. Patients will be randomized to one of two treatment groups, early internal fixation or nonoperative care with early rehabilitation, defined as at least five days of attempted mobilization by rehabilitation providers. Participants will be followed for 1 year.",[83,84,35,85],"Multiple Closed Pelvic Fractures With Disruption of Pelvic Ring","Fragility Fracture","Nonoperative Care",[84,87,88,89,35,85,90,91],"Lateral Compression type 1","Pelvis Fracture","Older Adults","Physical Therapy","Early","RECRUITING","2025-10-10",{"date":95,"type":60},"2025-10-15",{"date":97,"type":60},"2024-11-12",{"date":99,"type":22},"2027-12-31",{"name":101,"class":67},"University of Southern California",13,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":110,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":23,"phases":113,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":68},"100429227","three-cancellous-screws-versus-four-cancellous-screws-for-femoral-neck-fixation-100429227","NCT04869332","Three Cancellous Screws Versus Four Cancellous Screws for Femoral Neck Fixation","A Prospective Randomised Controlled Clinical Trial: Three Cancellous Screws Versus Four Cancellous Screws for Fixation of Femoral Neck Fractures","Inclusion Criteria:\n\n* Age ≥18 years\n* Patients with unilateral femoral neck fractures that will be treated with internal fixation\n* According to AO fracture classification, subjects with the fracture type (31-B)\n* Subjects (with the help of relatives) can understand the informed documents and patient questionnaires.\n* Subjects (with the help of relatives) voluntarily provide written informed consent to participate in the clinical study and authorize the transfer of their information to the sponsor.\n* The investigator believes that the subject can understand the clinical study, is willing and able to complete all research procedures and follow-up visits and can cooperate with the research procedures.\n* In-label use of the MCS.\n\nExclusion Criteria:\n\n* Subject does not provide voluntary consent to participate in the study.\n* The researcher believes that the subjects have conditions that affect the participation and follow-up of this study. (for example, the patient lives in a remote area or has difficulty in going back to the hospital for follow-up or does not cooperate with the medical guidance and suggestions of the surgeon.)\n* The subjects were pregnant or lactating women.\n* The researchers believe that the subjects have psychological disorders, which may affect the treatment outcome.\n* Garden classification III and IV of femoral neck fracture patients older than 65 years\n* Concurrent hip osteoarthritis.\n* Fractures where the operative treatment will occur more than three weeks after the primary injury\n* Patients combined with femoral head fractures(31-C), femoral shaft fractures(32-A\u002FB\u002FC) or femoral trochanteric area fracture (31-A1\u002FA2\u002FA3).\n* Pathological fracture (e.g., primary or metastatic tumor)\n* Serious soft tissue injury, judged by the investigator, will impact the union of the fracture, combined vascular injury, and combined osteofascial compartment syndrome\n* Multiple systemic injuries judged by researchers not suitable for enrollment.\n* Revision surgeries (for example, due to malunion, nonunion or infection)\n* Concurrent medical conditions judged by researchers not suitable for enrollment, such as: metabolic bone disease, post-polio syndrome, poor bone quality, prior history of poor fracture healing, etc\n* Patients with anaesthetic and surgical contraindications\n* Patients known to be allergic to implant components\n* Patients who are currently using chemotherapeutics or accepting radiotherapy, use systematically corticosteroid hormone or growth factor, or long-term use sedative hypnotics (continuous use over 3 months) or non-steroidal anti-inflammatory drugs (continuous use over 3 months)\n* Intemperance judged by researchers not suitable for enrollment (e.g., excessive daily drinking or smoking, drug abuse);\n* Subjects participated in other clinical studies in the past 3 months, which may affect the outcome and follow-up according to the judgment of researchers.\n* Subjects have significant neurological or musculoskeletal disorders or may have adverse effects on gait or weight-bearing (e.g., muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot arthropathy, avascular necrosis of the femoral head).","18 Years",{"count":112,"type":22},290,[25],"This study is a prospective randomized controlled clinical study. Patients with femoral neck fracture (AO classification 31-B) will be randomly divided into three-screw fixation group and four-screw fixation group. The internal fixation failure rate (IFFR) and functional outcomes of the two groups will be compared and the patients will be followed up to 2 years after surgery.",[116,35],"Femoral Neck Fractures",[118,119,120],"femoral neck fractures","multiple cancellous screws","RCT","2021-04-30",{"date":123,"type":60},"2021-05-03",{"date":125,"type":60},"2021-04-08",{"date":127,"type":22},"2026-12-31",{"name":129,"class":67},"Peking University Third Hospital"]