Evaluation of Isolated Stoppa Approach in BC Fracture AcetabulumPhase 2RCTNCT07896044
Stoppa Approach Vs Anterior & Posterior Fixation in Management of BC Fracture Acetabulum
A Phase 2 study testing Sequential anterior and posterior approaches for double column acetabular fractures and Isolated Modified Stoppa approach for management of double column acetabular fractures in people with Evaluation of Isolated Stoppa Approach in BC Fracture Acetabulum, run by Ain Shams University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Evaluation of Isolated Stoppa Approach in BC Fracture Acetabulum
- What is being tested?
- Sequential anterior and posterior approaches for double column acetabular fractures and Isolated Modified Stoppa approach for management of double column acetabular fractures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Sep 2026to 17 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Double-column acetabular fracture
- Age from 16 to 65 years, inclusive
- Recent acetabular fracture sustained within 14 days before enrollment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Isolated Modified Stoppa Approach With Posterior Column Screws Versus Sequential Anterior and Posterior Column Fixation in Management of Double Column Acetabular Fractures : A Randomised Controlled Trial - A Prospective Randomized Study
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.
Read the detailed description
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.
- Being tested
- Sequential anterior and posterior approaches for double column acetabular fractures, Isolated Modified Stoppa approach for management of double column acetabular fractures
- Keywords
- Modified Stoppa approach, double column fracture, quadrilateral plate fractures, posterior column screws, both column fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential anterior and posterior approaches for double column acetabular fracturesProcedure or surgery
starting with modified stoppa approach and suprapectineal plating, followed by the Kocher-Langenbeck approach and posterior column plating for double-column acetabular fractures
Isolated Modified Stoppa approach for management of double column acetabular fracturesProcedure or surgery
anatomical reduction and fixation of double column acetabular fractures via single anterior approach, utilizing anatomical quadrilateral plate and posterior column screws
| Study group | Role | What they receive |
|---|---|---|
| Fixation of double column Fracture acetabulum via sequential anterior & posterior approaches | Active comparator | anatomical reduction and fixation of double column fractures, starting with anterior approach and quadrilateral plate fixation, followed by posterior fixation via Kocher-Langenbeck approach Receives: Procedure: Sequential anterior and posterior approaches for double column acetabular fractures |
| Fixation of double column Fracture acetabulum via isolated Modified Stoppa approach | Experimental | anatomical reduction and fixation of double column fractures via isolated modified stoppa approach, utilizing anatomical quadrilateral plate and posterior column screws through the plate Receives: Procedure: Isolated Modified Stoppa approach for management of double column acetabular fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From immediately after surgery through 12 months after surgery.
Secondary outcomes (5)
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
Measured: up to 4 days postoperative
Mean operative time
The mean operation time was calculated in minutes and compared between the two study groups
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Intraoperatively, immediately after definitive fixation and before wound closure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start17 Sep 2026
- Primary completion16 Sep 2027 (estimated)
- Study completion17 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Evaluation of Isolated Stoppa Approach in BC Fracture AcetabulumStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An independent doctor created the randomization sequence using Excel 2016 (computerized random numbers) with a 1:1 allocation via random block sizes of 2, 4, and 6; he assigned the sample numbers equally to each group and assigned the block. Patients and physicians allocated to each intervention group were aware of the allocation; however, the data analysts and the outcome assessors were kept blinded to the allocation. We prospectively carried out this study on 60 patients with fractures involving both the column and acetabulum starting from September 17, 2026, that met our inclusion criteria. The independent doctor allocated the 60 cases to two groups: Group A (30 cases): Isolated modified stoppa approach; Group B (30 cases): Combined anterior and posterior approaches.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Moussa, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896044
- Sponsor's protocol ID
- FMASU R191/2026
- Acronym
- RCT
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meena BP, Dhakar A, Meena UK, Behera P, Roat KL. Modified Stoppa Approach Alone or in Combination with a Lateral Window for Acetabular Fractures Involving Both Columns. Hip Pelvis. 2025 Sep 1;37(3):230-237. doi: 10.5371/hp.2025.37.3.230.
PubMed 40889944
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolated Modified Stoppa Approach With Posterior Column Screws Versus Sequential Anterior and Posterior Column Fixation in Management of Double Column Acetabular Fractures : A Randomised Controlled Trial - A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07896044
- Acronym / sponsor ID
- RCT / FMASU R191/2026
- Keywords
- Modified Stoppa approach, double column fracture, quadrilateral plate fractures, posterior column screws, both column fracture
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 17 Sep 2026 (actual)
- Primary completion
- 16 Sep 2027 (estimated)
- Study completion
- 17 Sep 2027 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- An independent doctor created the randomization sequence using Excel 2016 (computerized random numbers) with a 1:1 allocation via random block sizes of 2, 4, and 6; he assigned the sample numbers equally to each group and assigned the block. Patients and physicians allocated to each intervention group were aware of the allocation; however, the data analysts and the outcome assessors were kept blinded to the allocation. We prospectively carried out this study on 60 patients with fractures involving both the column and acetabulum starting from September 17, 2026, that met our inclusion criteria. The independent doctor allocated the 60 cases to two groups: Group A (30 cases): Isolated modified stoppa approach; Group B (30 cases): Combined anterior and posterior approaches.
| Arm | Type | Receives |
|---|---|---|
| Fixation of double column Fracture acetabulum via sequential anterior & posterior approaches | Active comparator | Procedure: Sequential anterior and posterior approaches for double column acetabular fracturesanatomical reduction and fixation of double column fractures, starting with anterior approach and quadrilateral plate fixation, followed by posterior fixation via Kocher-Langenbeck approach |
| Fixation of double column Fracture acetabulum via isolated Modified Stoppa approach | Experimental | Procedure: Isolated Modified Stoppa approach for management of double column acetabular fracturesanatomical reduction and fixation of double column fractures via isolated modified stoppa approach, utilizing anatomical quadrilateral plate and posterior column screws through the plate |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Double-column acetabular fracture
- Age from 16 to 65 years, inclusive
- Recent acetabular fracture sustained within 14 days before enrollment
Key exclusion criteria (8 listed)
- Isolated anterior column fracture
- Isolated posterior column fracture
- Isolated anterior wall fracture
- Isolated posterior wall fracture
- Combined posterior wall and posterior column fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sequential anterior and posterior approaches for double column acetabular fracturesstarting with modified stoppa approach and suprapectineal plating, followed by the Kocher-Langenbeck approach and posterior column plating for double-column acetabular fractures | Procedure or surgery | Fixation of double column Fracture acetabulum via sequential anterior & posterior approaches |
| Isolated Modified Stoppa approach for management of double column acetabular fracturesanatomical reduction and fixation of double column acetabular fractures via single anterior approach, utilizing anatomical quadrilateral plate and posterior column screws | Procedure or surgery | Fixation of double column Fracture acetabulum via isolated Modified Stoppa approach |
Primary outcome
Rate of excellent, very good, good, average, or poor functional outcomes using the modified Merle d'Aubigné scoring system
Time frame: 1 year postoperative
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)
Rate of Anatomical, Congruent, or Incongruent Radiological Outcomes According to the Matta and Tornetta Radiological Principles
Time frame: 1 year postoperative
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.
Rate of implant failure
Time frame: Up to 12 months after surgery.
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.
Rate of recurrent fracture diastasis or secondary loss of reduction
Time frame: From immediately after surgery through 12 months after surgery.
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.
5 secondary outcomes
Mean intraoperative blood loss
Time frame: up to 4 days postoperative
Mean operative time
Time frame: It was calculated intraoperatively
Rate of unplanned reoperation
Time frame: Up to 12 months after the index operation.
Rate of postoperative surgical-site infection
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
Time frame: Intraoperatively, immediately after definitive fixation and before wound closure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Results publication: PubMed 40889944Meena BP, Dhakar A, Meena UK, Behera P, Roat KL. Modified Stoppa Approach Alone or in Combination with a Lateral Window for Acetabular Fractures Involving Both Columns. Hip Pelvis. 2025 Sep 1;37(3):230-237. doi: 10.5371/hp.2025.37.3.230.
- Reduction quality and hip function after internal fixation of acetabular double column fractures combined with posterior wall fractures with Stoppa approach in comparison to ilioinguinal approachLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sequential anterior and posterior approaches for double column acetabular fractures and Isolated Modified Stoppa approach for management of double column acetabular fractures in people with Evaluation of Isolated Stoppa Approach in BC Fracture Acetabulum, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of excellent, very good, good, average, or poor functional outcomes using the modified Merle d'Aubigné scoring system (time frame: 1 year postoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07896044, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.