[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654962":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":35,"studyPopulation":26,"armGroups":36,"interventions":49,"overallOfficials":26,"centralContacts":59,"locations":65,"responsibleParty":85,"collaborators":26,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":26,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":26,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":68,"whyStopped":26,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Idlib University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":26},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Fracture Union","Fracture union will be assessed using clinical and radiological criteria. Radiological healing will be evaluated on plain radiographs based on the formation of bridging callus across the fracture site and progressive disappearance of the fracture line. Clinical healing will be assessed based on the patient's clinical progress and ability to move the affected limb. Fracture status will be recorded as union or nonunion.","6 months postoperatively.",{"measure":14,"description":15,"timeFrame":16},"Time to Fracture Union","The time required to achieve fracture union will be recorded from the date of surgery until the first clinical and radiological evidence of complete fracture union.\n\nUnit of Measure: Months","Time Frame: Up to 6 months ]",{"measure":18,"description":19,"timeFrame":20},". Avascular Necrosis of the Femoral Head","The incidence of avascular necrosis of the femoral head will be assessed by plain radiographs during follow-up. The presence or absence of radiographic evidence of avascular necrosis will be recorded.\n\nUnit of Measure: Participants with avascular necrosis (number and percentage)","[Time Frame: 6 months postoperatively.]",[22],{"measure":23,"description":24,"timeFrame":25},"Harris Hip Score (HHS)","Clinical and functional outcomes will be assessed using the Harris Hip Score (HHS), a standardized numerical scoring system used to evaluate hip function following surgical intervention. The HHS includes assessment of pain, gait abnormalities (limp), functional activities, and range of motion of the hip joint. Pain and functional status will therefore be evaluated as components of the overall HHS rather than as separate outcome measures.\n\nUnit of Measure: Points on the Harris Hip Score, ranging from 0 to 100, with higher scores indicating better hip function.","3 months and 6 months postoperatively.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":33},"SINGLE",[34],"PARTICIPANT","Femoral neck fractures are serious injuries associated with a high risk of complications and represent an important challenge in orthopedic practice. Treatment decisions depend on several factors, including the patient's age, physiological status, activity level, associated comorbidities, and fracture displacement. In younger patients and in those with nondisplaced or minimally displaced fractures, internal fixation is generally preferred because preservation of the native femoral head and hip joint is an important treatment goal.\n\nFemoral neck fractures in young patients are usually caused by severe trauma and, although relatively uncommon, are associated with a high incidence of complications. Avascular necrosis (AVN) and late segmental collapse have been reported as major complications following these injuries, with particularly high complication rates described in young patients. Patients with subcapital fractures appear to be more susceptible to these complications. The high risk of AVN is related to the vulnerable blood supply of the femoral head, making preservation of femoral head vascularity a major concern in the treatment of femoral neck fractures.\n\nFor younger and active patients with displaced femoral neck fractures, anatomic reduction followed by stable internal fixation is considered essential, while internal fixation is also recommended for ambulatory patients with nondisplaced fractures to prevent secondary displacement. However, despite appropriate internal fixation, complications such as osteonecrosis and nonunion may still occur. The reported rate of osteonecrosis is approximately 10-30%, while nonunion has been reported in 8.9-30% of cases. These complications can lead to prolonged disability and may ultimately require additional surgical treatment.\n\nAutologous bone grafting has traditionally been used to augment bone regeneration in cases of osteonecrosis and nonunion, but its use may be associated with donor-site complications, including pain, bleeding, and infection. Consequently, biological approaches that can enhance fracture healing without the morbidity associated with bone graft harvesting have attracted increasing interest.\n\nBone marrow(BM) represent a potential alternative biological approach because they contain cell populations with osteogenic and angiogenic potential. Autologous BM transplantation offers several potential advantages, including relatively rapid isolation, avoidance of prolonged cell expansion, preservation of early progenitor characteristics, and the ability to use the cells without a prolonged delay between harvesting and treatment. Previous studies have also suggested beneficial effects of autologous BM in the treatment of femoral head osteonecrosis.\n\nBecause prevention of osteonecrosis and nonunion is preferable to treating these complications after they have developed, biological augmentation at the time of fracture fixation may represent a promising strategy. Therefore, combining stable internal fixation with an autologous biological treatment may provide a potential approach to improving fracture healing and reducing the risk of complications in patients with femoral neck fractures.",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"Group A:fixation using three fully threaded cancellous","ACTIVE_COMPARATOR","Patients will undergo surgical intervention on the fractured hip under appropriate anesthesia. Anatomical reduction of the fracture will be achieved under fluoroscopic guidance, followed by fixation through a lateral surgical approach to the hip using three fully threaded cancellous screws.",[42],"Procedure: Anatomical reduction with Fixation",{"label":44,"type":45,"description":46,"interventionNames":47},"Group B: Fixation using three fully cancellous screws with injection of autologous bone marrow","EXPERIMENTAL","Patients will undergo the same surgical procedure under appropriate anesthesia, with anatomical reduction of the fracture achieved under fluoroscopic guidance. The fracture will then be fixed through a lateral surgical approach using three fully threaded cancellous screws, in addition to the following procedure After drilling through the lateral femoral cortex toward the fracture line and advancing to the femoral head up to the subchondral bone, approximately 1-1.5 cm below the articular surface of the femoral head, 15 mL of autologous bone marrow will be aspirated from the iliac crest, approximately 1 cm posterior to the anterior superior iliac spine (ASIS), after ensuring that the site is included within the surgical field. The aspirate will be distributed into three heparin-prepared tubes.\n\nThe harvested autologous bone marrow will then be injected through the prepared screw channels to ensure delivery of the graft to the fracture site.\n\nThe screws will subsequently be inserted.",[48],"Procedure: Anatomical reduction and fixation with bone marrow injection",[50,55],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":26},"PROCEDURE","Anatomical reduction and fixation with bone marrow injection","Anatomical reduction of the fracture will be achieved under fluoroscopic guidance, followed by fixation through a lateral surgical approach to the hip using three fully threaded cancellous screws with using bone marrow injection",[44],{"type":51,"name":56,"description":57,"armGroupLabels":58,"otherNames":26},"Anatomical reduction with Fixation","Anatomical reduction of the fracture will be achieved under fluoroscopic guidance, followed by fixation through a lateral surgical approach to the hip using three fully threaded cancellous screws.",[38],[60],{"name":61,"role":62,"phone":63,"phoneExt":26,"email":64},"Mohamad M ISSA, MD","CONTACT","0954233150","mohamadalessa888@gmail.com",[66],{"facility":67,"status":68,"city":69,"state":26,"zip":26,"country":70,"countryCode":26,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Idlib university Faculty of medicine","RECRUITING","Idlib","Syria",{"type":72,"coordinates":73},"Point",[74,75],36.63393,35.93062,{"lat":75,"lon":74},[78,82],{"name":79,"role":62,"phone":80,"phoneExt":26,"email":81},"Yaser alkanash","+963 996 091 279","dr.yaseralkanash76@gmail.com",{"name":83,"role":84,"phone":26,"phoneExt":26,"email":26},"Ali Faraj, Phd","PRINCIPAL_INVESTIGATOR",{"type":86,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Yaser Alkanash","Dean of Scientific Affairs - Idlib University","100654962","bone-marrow-injection-in-fracture-of-femoral-neck-100654962",false,"NCT07808294","Bone Marrow Injection in Fracture of Femoral Neck","Outcome of Bone Marrow Injection at Fracture Site in Intracapsular Fracture of Femoral Neck Treated by Head Preserving Surgery","Inclusion Criteria:\n\n* Age between 18 and 55 years.\n* Intracapsular femoral neck fracture classified as Garden type III or IV.\n* The time elapsed since the fracture occurred must not exceed 24 hours\n\nExclusion Criteria:\n\n* Age under 18 years or over 55 years.\n* Open femoral neck fracture.\n* Neglected femoral neck fractures or fractures that occurred more than 24 hours prior to presentation.\n* Polytrauma patients who are in shock or admitted to the intensive care unit (ICU).","ALL","18 Years","55 Years",{"count":100,"type":101},32,"ESTIMATED","INTERVENTIONAL",[104],"NA","Objectives:\n\n* Primary objective :\n* To investigate the predisposing factors for femoral neck fractures, including age, sex, and associated comorbidities.\n* To investigate the complications associated with intracapsular femoral neck fractures, particularly in young patients.\n* To evaluate the effectiveness of autologous bone marrow injection at the femoral neck fracture site and its effect on:\n* Achieving complete fracture union.\n* Reducing the time required for fracture healing.\n* Reducing the incidence of avascular necrosis of the femoral head.\n* Secondary objective:\n\nThe study addresses the challenge of performing total hip arthroplasty in young patients. Complications following intracapsular femoral neck fractures, particularly avascular necrosis and nonunion, may ultimately necessitate this treatment option. However, total hip arthroplasty is generally less desirable in young patients because of:\n\n* Early prosthetic loosening.\n* The potential need for revision arthroplasty later in life due to wear and deterioration of prosthetic components over time.\n* Higher complication rates and lower long-term success rates. In this study, we will focus on the use of fully threaded cannulated screws combined with bone marrow injection into the fracture site, and evaluate their effect on the healing and union of intracapsular femoral neck fractures.",[107,108],"Bone Marrow","Femoral Neck Fractures",[110,111,112,113],"bone marrow","femoral neck","intracapsular fracture","avascular necrosis","2026-09-06",{"date":116,"type":117},"2026-09-08","ACTUAL",{"date":119,"type":117},"2025-05-12",{"date":121,"type":101},"2027-08-01",{"name":87,"class":6},1]