A Phase 2 interventional study of Sequential anterior and posterior approaches for double column acetabular fractures and Isolated Modified Stoppa approach for management of double column acetabular fractures in Evaluation of Isolated Stoppa Approach in BC Fracture Acetabulum, sponsored by Ain Shams University. Active, not recruiting at 1 site in Egypt. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Ain Shams University · Phase 2, Interventional, and Treatment
Double-column acetabular fractures are complex injuries that require stable anatomical reduction and fixation to restore hip function. These fractures may be treated using an isolated anterior approach with posterior column screw fixation or through sequential anterior and posterior column fixation. The relative benefits and risks of these two strategies remain uncertain.
This prospective randomized controlled trial will compare isolated fixation through the modified Stoppa approach with posterior column screws versus sequential anterior and posterior column fixation in participants with double-column acetabular fractures. Thirty participants will be randomly allocated to the two treatment groups. The study will compare radiological and functional outcomes, implant failure, recurrent diastasis, operative characteristics, complications, wound infection, and the need for additional surgery.
Double-column acetabular fractures are complex injuries that require stable anatomical reduction and fixation of both acetabular columns. Surgical management may be performed through an anterior intrapelvic approach with posterior column screw fixation or through sequential anterior and posterior column fixation. The optimal strategy remains uncertain because additional surgical exposure may improve direct visualization and fixation of the posterior column but may also increase operative time, blood loss, and approach-related morbidity.
This prospective randomized controlled clinical trial will compare isolated fixation through the modified Stoppa approach with posterior column screw fixation versus sequential anterior and posterior column fixation in the management of double-column acetabular fractures. The study will be conducted at Ain Shams University Hospitals. A total of 30 participants will be enrolled and allocated in a 1:1 ratio using a computer-generated randomization table. Fifteen participants will undergo fixation through an isolated modified Stoppa approach with posterior column screws, and 15 participants will undergo sequential anterior and posterior column fixation.
Preoperative assessment will follow Advanced Trauma Life Support principles. Initial fracture stabilization will be performed using appropriate skeletal traction when indicated. Clinical assessment will include documentation of associated injuries, medical comorbidities, medication use, and preinjury ambulatory status. Radiographic assessment will include anteroposterior pelvic radiographs, Judet views, and computed tomography for detailed evaluation and classification of the acetabular fracture according to the Letournel and Judet classification.
Surgery will be performed under general anesthesia on a radiolucent operating table. In the isolated anterior fixation group, acetabular exposure will be obtained through the modified Stoppa approach. A lateral window of the ilioinguinal approach may be added when visualization of the iliac wing or high anterior column is required. The modified Stoppa approach will provide access to the superior pubic ramus, pelvic brim, quadrilateral surface, anterior column, and medial surface of the posterior column. The corona mortis will be identified and ligated when present.
Fracture reduction will be performed under direct visualization using appropriate pelvic reduction instruments. Temporary fixation may be achieved using Kirschner wires. Definitive anterior fixation will be performed using precontoured 3.5-mm reconstruction plates along the pelvic brim, with supplementary infrapectineal buttress plating when required for quadrilateral surface involvement. Posterior column fixation will be achieved using column screws inserted under fluoroscopic guidance.
In the sequential fixation group, anterior and posterior column reduction and fixation will be performed sequentially through the planned anterior and posterior surgical exposures. Reduction and fixation of each column will be completed using reconstruction plates and screws according to the fracture configuration. Fluoroscopic anteroposterior, iliac oblique, and obturator oblique views will be used to assess fracture reduction and implant position in both study groups.
Postoperative management will follow a standardized protocol. Neurovascular assessment and postoperative pelvic radiographs will be performed after surgery. Antibiotic prophylaxis, thromboprophylaxis, analgesia, and rehabilitation will be provided according to the institutional protocol. Toe-touch weight bearing will be recommended during the initial six postoperative weeks, followed by progressive weight bearing and physiotherapy according to fracture stability and radiological progression.
Follow-up assessments will be conducted at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery. Clinical evaluation will include hip range of motion, limb-length discrepancy, ambulatory status, and recovery of function. Radiological evaluation will include standardized pelvic radiographs to assess reduction maintenance, fracture healing, recurrent displacement, and implant integrity. Functional and radiological findings, complications, operative characteristics, and the requirement for additional surgical intervention will be compared between the two treatment groups.
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Double-column acetabular fracture
Age from 16 to 65 years, inclusive
Recent acetabular fracture sustained within 14 days before enrollment
Exclusion Criteria:
Isolated anterior column fracture
Isolated posterior column fracture
Isolated anterior wall fracture
Isolated posterior wall fracture
Combined posterior wall and posterior column fracture
Previous surgical procedure involving the affected hip before the current injury
Pathological acetabular fracture
Open acetabular fracture
anatomical reduction and fixation of double column fractures, starting with anterior approach and quadrilateral plate fixation, followed by posterior fixation via Kocher-Langenbeck approach
Procedure: Sequential anterior and posterior approaches for double column acetabular fractures
anatomical reduction and fixation of double column fractures via isolated modified stoppa approach, utilizing anatomical quadrilateral plate and posterior column screws through the plate
Procedure: Isolated Modified Stoppa approach for management of double column acetabular fractures
starting with modified stoppa approach and suprapectineal plating, followed by the Kocher-Langenbeck approach and posterior column plating for double-column acetabular fractures
anatomical reduction and fixation of double column acetabular fractures via single anterior approach, utilizing anatomical quadrilateral plate and posterior column screws
Rate of excellent, very good, good, average, or poor functional outcomes using the modified Merle d'Aubigné scoring system
Clinical assessment was done via the Modified Merle d'Aubigné scoring system that was calculated at each follow-up visit (out of 18) and presented the mean value; the score evaluates three factors: pain, mobility \& ability to walk. The score maximum is 18 (excellent) and minimum is 6 (poor)
Time frame: 1 year postoperative
Rate of Anatomical, Congruent, or Incongruent Radiological Outcomes According to the Matta and Tornetta Radiological Principles
Radiological outcomes will be evaluated according to the Matta and Tornetta Radiological Principles using anteroposterior pelvic radiographs. Assessment will be based on restoration of the five anatomical lines: the iliopectineal line, ilioischial line, acetabular dome, anterior wall, and posterior wall. Each participant will be classified into one of three ordered categories: Anatomical, representing the best radiological outcome; congruent, representing an intermediate radiological outcome with preserved joint congruence; or incongruent, representing the worst radiological outcome with loss of joint congruence. The number and percentage of participants in each category will be reported for each treatment group. This is a categorical classification rather than a numerical scale; therefore, numerical minimum and maximum values do not apply.
Time frame: 1 year postoperative
Rate of implant failure
The incidence of implant failure will be compared between the isolated modified Stoppa approach with posterior column screw fixation group and the sequential anterior and posterior column fixation group. Implant failure will be defined as plate or screw breakage, bending, loosening, pull-out, migration, or loss of implant position identified on follow-up radiographs. Revision surgery performed because of mechanical failure of the fixation construct will also be recorded as an implant failure event. The rate will be calculated as the number of patients who develop implant failure divided by the total number of evaluable patients in each group, multiplied by 100.
Time frame: Up to 12 months after surgery.
Rate of recurrent fracture diastasis or secondary loss of reduction
Recurrent fracture diastasis will be defined as an increase of more than 2 mm in the postoperative displacement or separation of either the anterior or posterior acetabular column compared with the immediate postoperative radiographs. Assessment will be performed using standardized anteroposterior pelvic and Judet radiographs, with computed tomography obtained when plain radiographs are inconclusive. Revision surgery due to recurrent displacement or loss of reduction will also be recorded as an event. The rate will be calculated as the number of affected patients divided by the total number of evaluable patients in each group, multiplied by 100.
Time frame: From immediately after surgery through 12 months after surgery.
Mean intraoperative blood loss
The mean blood loss was calculated and compared between the two study groups, it was measured intraoperative and postoperative from suction drains
Time frame: up to 4 days postoperative
Mean operative time
The mean operation time was calculated in minutes and compared between the two study groups
Time frame: It was calculated intraoperatively
Rate of unplanned reoperation
The incidence of unplanned reoperation related to the index acetabular fracture or its surgical fixation will be compared between the two treatment groups. Reoperation will include revision fixation, implant removal due to complications, surgical treatment of infection, conversion to total hip arthroplasty, or any other unplanned surgical procedure related to failure of the initial treatment. Routinely planned procedures unrelated to a complication will not be considered reoperations. The reoperation rate will be calculated as the number of patients requiring at least one unplanned additional operation divided by the total number of evaluable patients in each group, multiplied by 100. The indication and type of each additional operation will also be recorded.
Time frame: Up to 12 months after the index operation.
Rate of postoperative surgical-site infection
The incidence of postoperative surgical-site infection will be compared between the two treatment groups. Infection will be classified as superficial incisional infection, involving only the skin or subcutaneous tissue, or deep incisional infection, involving the deep soft tissues, fascia, muscle, or fixation implants. Diagnosis will be based on clinical findings such as purulent wound discharge, wound dehiscence, erythema, swelling, local tenderness, fever, positive microbiological culture, or the need for antibiotic or surgical treatment. The infection rate will be calculated as the number of patients diagnosed with a surgical-site infection divided by the total number of evaluable patients in each group, multiplied by 100.
Time frame: p to 90 days after surgery. For implant-related or late infections, events will continue to be recorded for up to 12 months.
Quality of intraoperative acetabular fracture reduction
he quality of fracture reduction will be assessed intraoperatively after definitive fixation using fluoroscopic anteroposterior and Judet views. The maximum residual displacement or fracture gap involving the anterior column, posterior column, and articular surface will be measured in millimetres. Reduction will be classified according to the maximum residual displacement as anatomical (0-1 mm), imperfect (2-3 mm), or poor (greater than 3 mm). The measured displacement and distribution of reduction categories will be compared between the two treatment groups.
Time frame: Intraoperatively, immediately after definitive fixation and before wound closure.
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Started Sep 2026 (actual). Primary completion is estimated for Sep 2027, 11 months after the start.
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