An interventional study of Anatomical reduction and fixation with bone marrow injection and Anatomical reduction with Fixation in Bone Marrow and Femoral Neck Fractures, sponsored by Yaser Alkanash. Recruiting at 1 site in Syria. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Yaser Alkanash · Not applicable, Interventional, and Treatment
Objectives:
The 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:
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.
Femoral 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.
For 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.
Autologous 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.
Bone 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.
Because 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.
207 studies on the registry are indexed under Femoral Neck Fractures; 40 are open to participants now.
This study's planned enrollment of 32 is below the median of 100 across 142 interventional studies indexed under Femoral Neck Fractures.
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Exclusion Criteria:
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.
Procedure: Anatomical reduction with Fixation
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. The harvested autologous bone marrow will then be injected through the prepared screw channels to ensure delivery of the graft to the fracture site. The screws will subsequently be inserted.
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
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.
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.
Time frame: 6 months postoperatively.
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. Unit of Measure: Months
Time frame: Time Frame: Up to 6 months ]
. 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. Unit of Measure: Participants with avascular necrosis (number and percentage)
Time frame: [Time Frame: 6 months postoperatively.]
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. Unit of Measure: Points on the Harris Hip Score, ranging from 0 to 100, with higher scores indicating better hip function.
Time frame: 3 months and 6 months postoperatively.
Plan to share: Yes — site of injection and radiologic images
Supporting information: Clinical study report
Time frame: Individual participant data will become available after publication of the primary study results.
Access criteria: Anonymized individual participant data will be shared with qualified researchers upon reasonable request and approval by the study sponsor/institutional review committee. Data access will be subject to appropriate data-use and confidentiality agreements. De-identified individual participant data underlying the reported results may be shared with qualified researchers for scientifically appropriate research purposes, subject to ethical and institutional requirements.
Started May 2025 (actual). Primary completion is estimated for May 2027, 24 months after the start.
Of 63 non-industry interventional studies with no phase under Femoral Neck Fractures, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 62. This study's planned 24 months is below that.
Counting every sponsor, half of 69 studies reached it within 46 months; a quarter within 25 and three quarters within 68.
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