A Phase 2 interventional study of Dynamic Hip Screw with Anterotation Screw Fixation and Biplane Double-Supported Screw Fixation in Evaluation of BDSF in FNF, sponsored by Ain Shams University. Active, not recruiting at 1 site in Egypt. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Ain Shams University · Phase 2, Interventional, and Treatment
Pauwels type III femoral neck fractures in young adults commonly result from high-energy trauma and are characterized by a vertical fracture orientation with substantial shear and rotational forces. These fractures are associated with an increased risk of mechanical instability, nonunion, varus collapse, fixation failure, and osteonecrosis of the femoral head. Successful treatment therefore requires anatomical reduction and stable internal fixation capable of resisting both vertical shear and rotational forces.
A Sliding Hip Screw combined with an antirotation screw provides controlled fracture compression and additional rotational stability. Biplane Double Support Screw Fixation is an alternative technique in which cannulated screws are inserted in two planes to provide double cortical support. The distal screw entry points and calcar-supported configuration are intended to distribute axial loading toward the femoral diaphysis, improve mechanical stability, facilitate fracture impaction, and reduce the risk of varus collapse.
This prospective randomized controlled study will compare Biplane Double Support Screw Fixation with Sliding Hip Screw fixation combined with an antirotation screw in young adults with Pauwels type III femoral neck fractures. Participants will be randomly allocated in a 1:1 ratio to receive one of the two fixation techniques.
The study will compare fracture healing, functional recovery, radiological outcomes, and postoperative complications between the two groups. Particular attention will be given to nonunion, osteonecrosis of the femoral head, varus collapse, implant failure, and the need for additional surgery. The study hypothesis is that Biplane Double Support Screw Fixation may provide stable fixation with clinical and radiological outcomes comparable or superior to those achieved using a Sliding Hip Screw with an antirotation screw.
This prospective, randomized, controlled clinical study will be conducted at Ain Shams University Hospitals. Participants with acute Pauwels type III femoral neck fractures will be allocated in a 1:1 ratio using a computer-generated randomization table to undergo fixation using either Biplane Double Support Screw Fixation or a Sliding Hip Screw with an additional antirotation screw.
A minimum of 30 participants will be recruited, with 15 participants assigned to each treatment group. The sample size was calculated using a sample-size calculation program, with a two-sided alpha level of 0.05, statistical power exceeding 99%, and an anticipated dropout rate of 10%. The calculation was based on detecting a clinically meaningful difference in operative time between the two fixation techniques.
Preoperative assessment will include detailed history-taking, clinical examination, neurovascular evaluation of both lower limbs, and trauma assessment when clinically indicated. Radiographic evaluation will include an anteroposterior pelvic radiograph with both hips, a lateral radiograph of the affected hip, and radiographs of the entire femur and knee. Preoperative computed tomography of the pelvis will be performed when required to define the fracture configuration and assist surgical planning.
All procedures will be performed under anesthesia on a radiolucent operating table. Closed reduction will initially be attempted under fluoroscopic guidance. If satisfactory closed reduction cannot be achieved, open reduction will be performed through the Watson-Jones approach. A lateral approach will be used when adequate closed reduction is achieved.
Participants assigned to the first group will undergo Biplane Double Support Screw Fixation. Screws will be inserted in two supporting planes to provide fixation of the femoral neck fracture and resist vertical shear forces. Participants assigned to the second group will undergo fixation using a Sliding Hip Screw combined with an additional antirotation screw. Fluoroscopic anteroposterior and lateral views will be used intraoperatively to assess fracture reduction and implant position.
Postoperative management will be standardized for both groups. Antibiotic prophylaxis, thromboprophylaxis, analgesia, and neurovascular monitoring will be provided according to institutional protocols. Toe-touch weight bearing will be recommended during the first six postoperative weeks. Progressive partial weight bearing and physiotherapy will subsequently be initiated according to radiographic progression and fixation stability. Full weight bearing will generally be permitted after evidence of satisfactory fracture healing.
Clinical and radiographic follow-up will be performed at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery. Sutures will be removed at the 2-week visit, and passive and assisted active hip range-of-motion exercises will be initiated. Progressive weight bearing and strengthening exercises will begin during subsequent visits according to clinical and radiographic findings.
Data will be analyzed using the Statistical Package for the Social Sciences. Quantitative variables with a normal distribution will be summarized using means and standard deviations, while non-normally distributed variables will be presented using medians and interquartile ranges. Categorical variables will be summarized using frequencies and percentages. Appropriate statistical tests will be selected according to the type and distribution of the data. All statistical tests will be two-sided, and a P value of less than 0.05 will be considered statistically significant.
Written informed consent will be obtained from all participants before enrollment. The study will be conducted in accordance with applicable institutional ethical standards and will receive approval from the Faculty of Medicine, Ain Shams University Research Ethics Committee.
211 studies on the registry are indexed under Femoral Neck Fractures; 42 are open to participants now.
This study's enrollment of 30 is below the median of 100 across 147 interventional studies indexed under Femoral Neck Fractures.
Browse Femoral Neck Fractures studies →Ain Shams University is the lead sponsor of 1,932 studies on the registry; 433 are open to participants now.
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Exclusion Criteria:
DHS with anterotational screw for management of vertical femoral neck fractures as the standard of use
Procedure: Dynamic Hip Screw with Anterotation Screw Fixation
We used biplanar double support screw fixation for management of vertical femoral neck fractures
Procedure: Biplane Double-Supported Screw Fixation
nternal fixation of the femoral neck fracture using a dynamic hip screw with a side plate, supplemented with a parallel antirotation screw to improve rotational stability of the femoral head and neck fragment.
Internal fixation of the femoral neck fracture using three cannulated screws inserted according to the biplane double-supported screw fixation technique. The screws will be positioned in two oblique planes to obtain cortical support at the femoral neck and improve the biomechanical stability of the fracture fixation.
Rates of nonunion
Nonunion will be assessed using serial anteroposterior and lateral hip radiographs. It will be defined as failure of fracture healing with a persistent fracture line and absence of progressive trabecular or cortical bridging across the fracture site, with or without persistent pain during weight bearing, at 9 months after fixation. Cases requiring revision surgery for failure of fracture healing before the 9-month assessment will also be classified as nonunion. Radiographs will be independently evaluated by two orthopedic surgeons, with disagreements resolved by consensus. The nonunion rate will be calculated as the number of patients meeting the nonunion criteria divided by the total number of evaluable patients, multiplied by 100.
Time frame: up to 1 year postoperative
Functional outcome assessed using the Harris Hip Score was evaluated and calculated at each follow-up visit, with the mean value presented
Hip function will be evaluated using the Harris Hip Score (HHS), which assesses pain, function, absence of deformity, and hip range of motion. The total score ranges from 0 to 100 points, with higher scores indicating better hip function. Results will be classified as excellent (90-100), good (80-89), fair (70-79), or poor (\<70). The mean HHS and the proportion of patients within each functional category will be reported.
Time frame: At 3, 6, and 12 months after surgery.
Rate of osteonecrosis of the femoral head
Osteonecrosis of the femoral head will be assessed using serial anteroposterior and lateral hip radiographs. Diagnosis will be based on the development of characteristic radiographic changes, including femoral head sclerosis, cystic changes, subchondral collapse, crescent sign, or loss of femoral head sphericity. Magnetic resonance imaging will be performed when osteonecrosis is clinically suspected but not confirmed on plain radiographs. Osteonecrosis will be classified according to the Association Research Circulation Osseous (ARCO) classification. Patients who undergo revision surgery or conversion to hip arthroplasty because of osteonecrosis will be considered to have reached the outcome. The osteonecrosis rate will be calculated as the number of patients diagnosed with osteonecrosis divided by the total number of evaluable patients, multiplied by 100.
Time frame: Up to 12 months after surgery.
Mean Operative Time
The mean operation time was calculated and compared between the two study groups
Time frame: It was calculated intra-operative
Mean Intraoperative Blood Loss
The mean blood loss was calculated and compared between the two study groups; it was measured intraoperatively and postoperative from suction drains
Time frame: Up to 4 days postoperative
Need For Another Operations' Rate
The need for another operation was observed and compared between the two study groups
Time frame: Through study completion, an average of 1 year postoperative
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Plan to share: No
Started Sep 2024 (actual). Primary completion is estimated for Mar 2027, 30 months after the start.
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