Developmental Dysplasia of the HipNCT07904637
3D-Printed Pelvic Models for Planning Complex Total Hip Arthroplasty
An observational study of Developmental Dysplasia of the Hip and Acetabular Bone Loss, run by Ain Shams University at 1 site in Egypt.
Trial summary
Total hip arthroplasty (THA) in patients with complex acetabular anatomy can be challenging because of abnormal bone structure, deformity, or bone loss. Accurate preoperative planning is important for selecting the appropriate acetabular component, determining its position, and achieving stable fixation. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Developmental Dysplasia of the Hip, Acetabular Bone Loss, Acetabular Fracture
- What is being tested?
- Conventional Imaging-Based Preoperative Planning and CT-Based 3D-Printed Pelvic Model-Assisted Planning
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2026to 1 Nov 2028
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will consist of patients aged 16 years or older undergoing primary or revision total hip arthroplasty at Ain Shams University Hospitals for complex acetabular anatomy. Eligible patients will include those with high-grade developmental dysplasia of the hip (Crowe III-IV), revision total hip arthroplasty with acetabular bone loss (Paprosky IIC-IIIB), or post-traumatic acetabular pathology. Consecutive eligible patients will be recruited during the study period. The anticipated sample size is approximately 10 hips. All participants will undergo preoperative assessment and postoperative follow-up for six months.
Who may be able to join
- Patients aged 16 years or older.
- Patients indicated for primary or revision total hip arthroplasty with complex acetabular anatomy, including at least one of the following:
- Revision total hip arthroplasty with acetabular bone loss, such as Paprosky type IIC to IIIB.
- Primary total hip arthroplasty for high-grade developmental dysplasia of the hip, Crowe type III or IV.
- Post-traumatic acetabular fracture.
Who cannot join
- Active periprosthetic joint infection.
- Inability to comply with postoperative follow-up visits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Ain Shams University Hospitals
Cairo, Cairo Governorate
Mohamed S El-zyati, MD, +201061768519, Mohamed-Elzyati@med.asu.edu.eg
About this study
Official title: CT Based 3D Printed Pelvic Models for Pre-Operative Planning in Total Hip Arthroplasty With Complex Acetabular Anatomy: A Prospective Within-Case Comparative Planning Study
Total hip arthroplasty (THA) in patients with complex acetabular anatomy can be challenging because of abnormal bone structure, deformity, or bone loss. Accurate preoperative planning is important for selecting the appropriate acetabular component, determining its position, and achieving stable fixation.
This prospective study aims to evaluate whether patient-specific, CT-based three-dimensional (3D)-printed pelvic models improve preoperative planning in complex total hip arthroplasty compared with conventional radiographic and CT-based planning.
Read more
Patients undergoing complex primary or revision THA at Ain Shams University Hospitals will be included. For each patient, two preoperative plans will be prepared. Plan A will use conventional radiographs and CT images, while Plan B will additionally use a life-size 3D-printed pelvic model for surgical planning and simulation.
Both plans will be compared with the actual acetabular component size and orientation achieved during surgery. The study will also evaluate changes in surgical planning, restoration of the hip center, operative parameters, postoperative complications, functional outcomes, and the practical feasibility of 3D printing.
Patients will undergo postoperative follow-up for six months.
The study seeks to determine the additional value of 3D-printed pelvic models in improving planning accuracy and supporting surgical decision-making in complex hip replacement.
Read the detailed description
Background and Rationale
Complex acetabular anatomy represents a significant challenge in total hip arthroplasty (THA), particularly in patients with high-grade developmental dysplasia of the hip, post-traumatic acetabular deformities, and revision THA with acetabular bone loss.
Conventional preoperative planning relies on plain radiographs and computed tomography (CT). Although CT provides detailed anatomical information, irregular three-dimensional bone defects may remain difficult to assess using images displayed on a screen.
Patient-specific 3D-printed pelvic models provide physical representations of acetabular anatomy, allowing direct visualization, tactile assessment, implant templating, and simulation of reconstructive procedures before surgery.
Study Objectives
The primary objective is to compare conventional imaging-based planning with 3D-printed-model-assisted planning in predicting the acetabular component size and orientation achieved during THA.
Secondary objectives include evaluating hip center and offset restoration, changes in surgical strategy, agreement of preoperative Paprosky classification with intraoperative assessment, operative parameters, early postoperative outcomes, and the feasibility of producing and using 3D-printed models.
Study Design and Setting
This is a prospective, single-center, paired within-case comparative planning study conducted at Ain Shams University Hospitals, Department of Orthopaedic Surgery.
Eligible patients undergoing complex primary or revision THA will be consecutively recruited. Each included hip will undergo two sequential preoperative planning assessments using the same patient imaging data.
Preoperative Assessment
All patients will undergo clinical evaluation, baseline functional assessment, standard pelvic and hip radiographs, and thin-slice CT imaging.
Acetabular anatomy will be assessed using appropriate classifications, including the Crowe classification for developmental dysplasia and the Paprosky classification for revision acetabular bone defects.
Paired Planning Procedure
Plan A, Conventional Planning:
Surgeons will perform preoperative planning using standard radiographs and CT images without access to the physical 3D-printed model.
The planned acetabular cup size, inclination, anteversion, need for augmentation or reconstruction, fixation screw strategy, and surgeon confidence will be documented before the printed model is reviewed.
Plan B, 3D-Printed-Model-Assisted Planning:
CT DICOM data will be segmented and converted into a patient-specific three-dimensional pelvic model. A life-size physical model will be produced using 3D-printing technology.
Surgeons will review the model and perform hands-on planning or simulation, including assessment of acetabular defects, anticipated reaming, cup positioning, implant sizing, reconstruction options, and screw trajectories.
The revised surgical plan will then be documented using the same standardized planning parameters.
Paprosky Classification Assessment
For revision cases, two arthroplasty surgeons will independently classify acetabular defects using conventional imaging.
After an interval of at least two weeks, classification will be repeated using imaging combined with the 3D-printed model.
The intraoperative Paprosky classification recorded by the senior surgeon will serve as the reference for agreement analysis.
Operative Procedure
THA will be performed according to standard departmental surgical techniques using the final 3D-model-assisted planning strategy.
Intraoperative documentation will include actual acetabular component size, implant orientation, additional reconstruction requirements, fixation details, operative duration, estimated blood loss, complications, and deviations from the preoperative plan.
Assessment of Planning Accuracy
The predictions generated by Plan A and Plan B will be compared with the achieved surgical results.
Cup size agreement will be evaluated using exact matching and agreement within one implant size or approximately 2 mm.
Cup orientation agreement will be evaluated by calculating the absolute differences between planned and achieved inclination and anteversion.
Additional analyses will examine changes in implant selection, acetabular reconstruction strategy, screw planning, and agreement between preoperative and intraoperative defect classification.
Postoperative Follow-Up
Immediate postoperative radiographs will be obtained.
Patients will undergo follow-up examinations at six weeks, three months, and six months after surgery.
Clinical and radiographic assessments will document functional recovery, hip reconstruction, and complications including dislocation, loosening, fracture, infection, nerve injury, and thromboembolic events.
Feasibility Assessment
The study will document the time required for CT data processing, segmentation, printing, and surgical planning, together with model production costs and surgeon satisfaction.
Statistical Analysis
Continuous variables will be summarized using means and standard deviations or medians and interquartile ranges, as appropriate. Categorical variables will be presented as frequencies and percentages.
Paired continuous measurements will be compared using paired t-tests or Wilcoxon signed-rank tests according to data distribution.
Categorical paired outcomes will be analyzed using McNemar tests where appropriate. Agreement in acetabular defect classification will be evaluated using percentage agreement and Cohen's kappa statistics.
The findings will be used to assess the additional planning information provided by patient-specific 3D-printed pelvic models in complex THA.
- Being tested
- Conventional Imaging-Based Preoperative Planning, CT-Based 3D-Printed Pelvic Model-Assisted Planning
- Keywords
- Total Hip Arthroplasty, 3D Printing, Patient-Specific Pelvic Models, Preoperative Planning, Computed Tomography, Complex Acetabular Anatomy, Revision Hip Arthroplasty, Acetabular Reconstruction, Acetabular Cup Positioning, Paprosky Classification
- Medical subject headings
- Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Imaging-Based Preoperative PlanningOther
Preoperative planning of total hip arthroplasty using standard pelvic and hip radiographs and CT images without reviewing the 3D-printed pelvic model. The surgeon will document the planned acetabular cup size, inclination, anteversion, anticipated need for augments or cages, screw fixation strategy, and confidence level (0-10). This initial plan (Plan A) will be recorded and locked before the 3D-printed model is reviewed.
CT-Based 3D-Printed Pelvic Model-Assisted PlanningOther
Patient-specific, life-size 3D-printed pelvic models will be generated from preoperative CT DICOM data through image segmentation and 3D printing. Surgeons will use the models for anatomical assessment and hands-on simulation of acetabular reaming, cup sizing and positioning, augment or cage selection, and screw trajectory planning. The model-assisted plan (Plan B) will be documented and compared with Plan A and the achieved surgical results.
| Study group | Role | What they receive |
|---|---|---|
| Complex Acetabular THA Patients | Patients undergoing primary or revision total hip arthroplasty (THA) for complex acetabular anatomy, including high-grade developmental dysplasia of the hip (Crowe III-IV), revision THA with acetabular bone loss (Paprosky IIC-IIIB), and post-traumatic acetabular deformities.
Each included case will undergo two sequential preoperative planning assessments: conventional radiographic and CT-based planning (Plan A), followed by CT-based 3D-printed pelvic model-assisted planning (Plan B). The accuracy of both plans will be compared with the achieved surgical results. Patients will be followed postoperatively for six months. Receives: Other: Conventional Imaging-Based Preoperative Planning; Other: CT-Based 3D-Printed Pelvic Model-Assisted Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exact Acetabular Cup Size Prediction Accuracy
The percentage of cases in which the planned acetabular cup size exactly matches the actual implanted cup size. Exact matching will be assessed separately for conventional imaging-based planning (Plan A) and 3D-printed-model-assisted planning (Plan B), using the intraoperative implant record as the reference.
Measured: During surgery
Acetabular Cup Size Prediction Accuracy Within 2 mm
The percentage of cases in which the planned acetabular cup size is within 2 mm or one implant size of the actual implanted cup size. Accuracy will be calculated separately for Plan A and Plan B and compared using the intraoperative implant record.
Measured: During surgery
Absolute Error in Acetabular Cup Inclination
The absolute difference, measured in degrees, between the planned acetabular cup inclination and the achieved postoperative cup inclination. Errors will be calculated separately for Plan A and Plan B using postoperative radiographic or CT measurements, allowing a paired comparison of planning accuracy.
Measured: Immediate postoperative imaging
Absolute Error in Acetabular Cup Anteversion
The absolute difference, measured in degrees, between the planned acetabular cup anteversion and the achieved postoperative cup anteversion. Errors will be calculated separately for Plan A and Plan B using postoperative radiographic or CT measurements, allowing a paired comparison of planning accuracy.
Measured: Immediate postoperative imaging
Secondary outcomes (11)
Changes in Preoperative Surgical Planning
Percentage of cases in which Plan B differs from Plan A in planned cup size, target cup orientation, augment or cage requirement, or screw fixation strategy. Each type of planning change will be recorded.
Measured: During preoperative planning
Agreement of Paprosky Classification With Intraoperative Findin
Percentage agreement and Cohen's kappa between Paprosky classifications obtained from conventional imaging (Plan A) and 3D-model-assisted assessment (Plan B), compared with the intraoperative classification recorded by the senior surgeon.
Measured: Preoperative assessment and during surgery SECONDARY OUTCOME
Restoration of Hip Center and Offset
Radiographic assessment of the hip center and hip offset before and after total hip arthroplasty. Measurements will be recorded in millimeters to evaluate postoperative anatomical restoration.
Measured: Preoperative assessment and immediate postoperative imaging
Agreement Between Planned and Actual Acetabular Reconstruction
Agreement between the anticipated need for acetabular augments, buttresses, or cages in Plan A and Plan B and the reconstructive components actually used during surgery. Results will be reported by reconstruction category.
Measured: During surgery
Operative Time
Duration of total hip arthroplasty, measured in minutes and recorded for each surgical case.
Measured: During surgery
Estimated Intraoperative Blood Loss
Estimated volume of blood lost during total hip arthroplasty, measured in milliliters.
Measured: During surgery
Incidence of Intraoperative Complications
Number and percentage of patients experiencing intraoperative complications during total hip arthroplasty, with the type of complication recorded.
Measured: During surgery
Incidence of Postoperative Complications
Number and percentage of patients experiencing postoperative complications, including dislocation, loosening, fracture, infection, nerve palsy, and thromboembolic events.
Measured: From surgery through 6-month postoperative follow-up
Change in Postoperative Hip Functional Score
Change from baseline in hip function assessed using the Harris Hip Score and/or Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS-JR), according to the functional instrument selected in the study protocol.
Measured: Baseline, 6 weeks, 3 months, and 6 months postoperatively
Surgeon Confidence in Preoperative Planning
Surgeon-reported confidence in each preoperative plan, measured using a numeric rating scale from 0 to 10. Scores will be recorded separately for Plan A and Plan B.
Measured: Immediately after completion of each preoperative plan
Number of Unplanned Implants Opened During Surgery
Number of additional or unplanned implants opened during surgery, including acetabular cups, liners, augments, cages, and screws, where inventory documentation is available.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Developmental Dysplasia of the HipStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904637
- Sponsor's protocol ID
- ASU-ORTHO-3DTHA-2026
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Won SH, Lee YK, Ha YC, Suh YS, Koo KH. Improving pre-operative planning for complex total hip replacement with a Rapid Prototype model enabling surgical simulation. Bone Joint J. 2013 Nov;95-B(11):1458-63. doi: 10.1302/0301-620X.95B11.31878.
PubMed 24151263Hughes AJ, DeBuitleir C, Soden P, O'Donnchadha B, Tansey A, Abdulkarim A, McMahon C, Hurson CJ. 3D Printing Aids Acetabular Reconstruction in Complex Revision Hip Arthroplasty. Adv Orthop. 2017;2017:8925050. doi: 10.1155/2017/8925050. Epub 2017 Jan 10.
PubMed 28168060Jiang M, Coles-Black J, Chen G, Alexander M, Chuen J, Hardidge A. 3D Printed Patient-Specific Complex Hip Arthroplasty Models Streamline the Preoperative Surgical Workflow: A Pilot Study. Front Surg. 2021 Aug 26;8:687379. doi: 10.3389/fsurg.2021.687379. eCollection 2021.
PubMed 34513912Maryada VR, Mulpur P, Eachempati KK, Annapareddy A, Badri Narayana Prasad V, Gurava Reddy AV. Pre-operative planning and templating with 3-D printed models for complex primary and revision total hip arthroplasty. J Orthop. 2022 Sep 13;34:240-245. doi: 10.1016/j.jor.2022.09.004. eCollection 2022 Nov-Dec.
PubMed 36120476Aguado-Maestro I, Simon-Perez C, Garcia-Alonso M, Ailagas-De Las Heras JJ, Paredes-Herrero E. Clinical Applications of "In-Hospital" 3D Printing in Hip Surgery: A Systematic Narrative Review. J Clin Med. 2024 Jan 20;13(2):599. doi: 10.3390/jcm13020599.
PubMed 38276105Ryu HG, Kim KH, Ahn SJ, Kim SM. Mid-Term Outcomes of Acetabular Reconstruction Using a Rapid Prototyping Pelvic Model in Complex Total Hip Arthroplasty. Yonsei Med J. 2025 Dec;66(12):851-856. doi: 10.3349/ymj.2025.0001.
PubMed 41287497
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Based 3D Printed Pelvic Models for Pre-Operative Planning in Total Hip Arthroplasty With Complex Acetabular Anatomy: A Prospective Within-Case Comparative Planning Study
- ClinicalTrials.gov ID
- NCT07904637
- Acronym / sponsor ID
- ASU-ORTHO-3DTHA-2026
- Keywords
- Total Hip Arthroplasty, 3D Printing, Patient-Specific Pelvic Models, Preoperative Planning, Computed Tomography, Complex Acetabular Anatomy, Revision Hip Arthroplasty, Acetabular Reconstruction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 29 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.
Total hip arthroplasty (THA) in patients with complex acetabular anatomy can be challenging because of abnormal bone structure, deformity, or bone loss. Accurate preoperative planning is important for selecting the appropriate acetabular component, determining its position, and achieving stable fixation.
This prospective study aims to evaluate whether patient-specific, CT-based three-dimensional (3D)-printed pelvic models improve preoperative planning in complex total hip arthroplasty compared with conventional radiographic and CT-based planning.
Patients undergoing complex primary or revision THA at Ain Shams University Hospitals will be included. For each patient, two preoperative plans will be prepared. Plan A will use conventional radiographs and CT images, while Plan B will additionally use a life-size 3D-printed pelvic model for surgical planning and simulation.
Both plans will be compared with the actual acetabular component size and orientation achieved during surgery. The study will also evaluate changes in surgical planning, restoration of the hip center, operative parameters, postoperative complications, functional outcomes, and the practical feasibility of 3D printing.
Patients will undergo postoperative follow-up for six months.
The study seeks to determine the additional value of 3D-printed pelvic models in improving planning accuracy and supporting surgical decision-making in complex hip replacement.
Detailed description
Background and Rationale
Complex acetabular anatomy represents a significant challenge in total hip arthroplasty (THA), particularly in patients with high-grade developmental dysplasia of the hip, post-traumatic acetabular deformities, and revision THA with acetabular bone loss.
Conventional preoperative planning relies on plain radiographs and computed tomography (CT). Although CT provides detailed anatomical information, irregular three-dimensional bone defects may remain difficult to assess using images displayed on a screen.
Patient-specific 3D-printed pelvic models provide physical representations of acetabular anatomy, allowing direct visualization, tactile assessment, implant templating, and simulation of reconstructive procedures before surgery.
Study Objectives
The primary objective is to compare conventional imaging-based planning with 3D-printed-model-assisted planning in predicting the acetabular component size and orientation achieved during THA.
Secondary objectives include evaluating hip center and offset restoration, changes in surgical strategy, agreement of preoperative Paprosky classification with intraoperative assessment, operative parameters, early postoperative outcomes, and the feasibility of producing and using 3D-printed models.
Study Design and Setting
This is a prospective, single-center, paired within-case comparative planning study conducted at Ain Shams University Hospitals, Department of Orthopaedic Surgery.
Eligible patients undergoing complex primary or revision THA will be consecutively recruited. Each included hip will undergo two sequential preoperative planning assessments using the same patient imaging data.
Preoperative Assessment
All patients will undergo clinical evaluation, baseline functional assessment, standard pelvic and hip radiographs, and thin-slice CT imaging.
Acetabular anatomy will be assessed using appropriate classifications, including the Crowe classification for developmental dysplasia and the Paprosky classification for revision acetabular bone defects.
Paired Planning Procedure
Plan A, Conventional Planning:
Surgeons will perform preoperative planning using standard radiographs and CT images without access to the physical 3D-printed model.
The planned acetabular cup size, inclination, anteversion, need for augmentation or reconstruction, fixation screw strategy, and surgeon confidence will be documented before the printed model is reviewed.
Plan B, 3D-Printed-Model-Assisted Planning:
CT DICOM data will be segmented and converted into a patient-specific three-dimensional pelvic model. A life-size physical model will be produced using 3D-printing technology.
Surgeons will review the model and perform hands-on planning or simulation, including assessment of acetabular defects, anticipated reaming, cup positioning, implant sizing, reconstruction options, and screw trajectories.
The revised surgical plan will then be documented using the same standardized planning parameters.
Paprosky Classification Assessment
For revision cases, two arthroplasty surgeons will independently classify acetabular defects using conventional imaging.
After an interval of at least two weeks, classification will be repeated using imaging combined with the 3D-printed model.
The intraoperative Paprosky classification recorded by the senior surgeon will serve as the reference for agreement analysis.
Operative Procedure
THA will be performed according to standard departmental surgical techniques using the final 3D-model-assisted planning strategy.
Intraoperative documentation will include actual acetabular component size, implant orientation, additional reconstruction requirements, fixation details, operative duration, estimated blood loss, complications, and deviations from the preoperative plan.
Assessment of Planning Accuracy
The predictions generated by Plan A and Plan B will be compared with the achieved surgical results.
Cup size agreement will be evaluated using exact matching and agreement within one implant size or approximately 2 mm.
Cup orientation agreement will be evaluated by calculating the absolute differences between planned and achieved inclination and anteversion.
Additional analyses will examine changes in implant selection, acetabular reconstruction strategy, screw planning, and agreement between preoperative and intraoperative defect classification.
Postoperative Follow-Up
Immediate postoperative radiographs will be obtained.
Patients will undergo follow-up examinations at six weeks, three months, and six months after surgery.
Clinical and radiographic assessments will document functional recovery, hip reconstruction, and complications including dislocation, loosening, fracture, infection, nerve injury, and thromboembolic events.
Feasibility Assessment
The study will document the time required for CT data processing, segmentation, printing, and surgical planning, together with model production costs and surgeon satisfaction.
Statistical Analysis
Continuous variables will be summarized using means and standard deviations or medians and interquartile ranges, as appropriate. Categorical variables will be presented as frequencies and percentages.
Paired continuous measurements will be compared using paired t-tests or Wilcoxon signed-rank tests according to data distribution.
Categorical paired outcomes will be analyzed using McNemar tests where appropriate. Agreement in acetabular defect classification will be evaluated using percentage agreement and Cohen's kappa statistics.
The findings will be used to assess the additional planning information provided by patient-specific 3D-printed pelvic models in complex THA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Complex Acetabular THA Patients | – | Other: Conventional Imaging-Based Preoperative Planning, Other: CT-Based 3D-Printed Pelvic Model-Assisted PlanningPatients undergoing primary or revision total hip arthroplasty (THA) for complex acetabular anatomy, including high-grade developmental dysplasia of the hip (Crowe III-IV), revision THA with acetabular bone loss (Paprosky IIC-IIIB), and post-traumatic acetabular deformities. Each included case will undergo two sequential preoperative planning assessments: conventional radiographic and CT-based planning (Plan A), followed by CT-based 3D-printed pelvic model-assisted planning (Plan B). The accuracy of both plans will be compared with the achieved surgical results. Patients will be followed postoperatively for six months. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of patients aged 16 years or older undergoing primary or revision total hip arthroplasty at Ain Shams University Hospitals for complex acetabular anatomy. Eligible patients will include those with high-grade developmental dysplasia of the hip (Crowe III-IV), revision total hip arthroplasty with acetabular bone loss (Paprosky IIC-IIIB), or post-traumatic acetabular pathology. Consecutive eligible patients will be recruited during the study period. The anticipated sample size is approximately 10 hips. All participants will undergo preoperative assessment and postoperative follow-up for six months.
Key inclusion criteria (5 listed)
- Patients aged 16 years or older.
- Patients indicated for primary or revision total hip arthroplasty with complex acetabular anatomy, including at least one of the following:
Key exclusion criteria (2 listed)
- Active periprosthetic joint infection.
- Inability to comply with postoperative follow-up visits.
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 |
|---|---|---|
| Conventional Imaging-Based Preoperative PlanningPreoperative planning of total hip arthroplasty using standard pelvic and hip radiographs and CT images without reviewing the 3D-printed pelvic model. The surgeon will document the planned acetabular cup size, inclination, anteversion, anticipated need for augments or cages, screw fixation strategy, and confidence level (0-10). This initial plan (Plan A) will be recorded and locked before the 3D-printed model is reviewed. | Other | Complex Acetabular THA Patients |
| CT-Based 3D-Printed Pelvic Model-Assisted PlanningPatient-specific, life-size 3D-printed pelvic models will be generated from preoperative CT DICOM data through image segmentation and 3D printing. Surgeons will use the models for anatomical assessment and hands-on simulation of acetabular reaming, cup sizing and positioning, augment or cage selection, and screw trajectory planning. The model-assisted plan (Plan B) will be documented and compared with Plan A and the achieved surgical results. | Other | Complex Acetabular THA Patients |
Primary outcome
Exact Acetabular Cup Size Prediction Accuracy
Time frame: During surgery
The percentage of cases in which the planned acetabular cup size exactly matches the actual implanted cup size. Exact matching will be assessed separately for conventional imaging-based planning (Plan A) and 3D-printed-model-assisted planning (Plan B), using the intraoperative implant record as the reference.
Acetabular Cup Size Prediction Accuracy Within 2 mm
Time frame: During surgery
The percentage of cases in which the planned acetabular cup size is within 2 mm or one implant size of the actual implanted cup size. Accuracy will be calculated separately for Plan A and Plan B and compared using the intraoperative implant record.
Absolute Error in Acetabular Cup Inclination
Time frame: Immediate postoperative imaging
The absolute difference, measured in degrees, between the planned acetabular cup inclination and the achieved postoperative cup inclination. Errors will be calculated separately for Plan A and Plan B using postoperative radiographic or CT measurements, allowing a paired comparison of planning accuracy.
Absolute Error in Acetabular Cup Anteversion
Time frame: Immediate postoperative imaging
The absolute difference, measured in degrees, between the planned acetabular cup anteversion and the achieved postoperative cup anteversion. Errors will be calculated separately for Plan A and Plan B using postoperative radiographic or CT measurements, allowing a paired comparison of planning accuracy.
11 secondary outcomes
Changes in Preoperative Surgical Planning
Time frame: During preoperative planning
Agreement of Paprosky Classification With Intraoperative Findin
Time frame: Preoperative assessment and during surgery SECONDARY OUTCOME
Restoration of Hip Center and Offset
Time frame: Preoperative assessment and immediate postoperative imaging
Agreement Between Planned and Actual Acetabular Reconstruction
Time frame: During surgery
Operative Time
Time frame: During surgery
Estimated Intraoperative Blood Loss
Time frame: During surgery
Incidence of Intraoperative Complications
Time frame: During surgery
Incidence of Postoperative Complications
Time frame: From surgery through 6-month postoperative follow-up
Change in Postoperative Hip Functional Score
Time frame: Baseline, 6 weeks, 3 months, and 6 months postoperatively
Surgeon Confidence in Preoperative Planning
Time frame: Immediately after completion of each preoperative plan
Number of Unplanned Implants Opened During Surgery
Time frame: During surgery
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 29 Oct 2026.
- Results publication: PubMed 24151263Won SH, Lee YK, Ha YC, Suh YS, Koo KH. Improving pre-operative planning for complex total hip replacement with a Rapid Prototype model enabling surgical simulation. Bone Joint J. 2013 Nov;95-B(11):1458-63. doi: 10.1302/0301-620X.95B11.31878.
- Results publication: PubMed 28168060Hughes AJ, DeBuitleir C, Soden P, O'Donnchadha B, Tansey A, Abdulkarim A, McMahon C, Hurson CJ. 3D Printing Aids Acetabular Reconstruction in Complex Revision Hip Arthroplasty. Adv Orthop. 2017;2017:8925050. doi: 10.1155/2017/8925050. Epub 2017 Jan 10.
- Results publication: PubMed 34513912Jiang M, Coles-Black J, Chen G, Alexander M, Chuen J, Hardidge A. 3D Printed Patient-Specific Complex Hip Arthroplasty Models Streamline the Preoperative Surgical Workflow: A Pilot Study. Front Surg. 2021 Aug 26;8:687379. doi: 10.3389/fsurg.2021.687379. eCollection 2021.
- Results publication: PubMed 36120476Maryada VR, Mulpur P, Eachempati KK, Annapareddy A, Badri Narayana Prasad V, Gurava Reddy AV. Pre-operative planning and templating with 3-D printed models for complex primary and revision total hip arthroplasty. J Orthop. 2022 Sep 13;34:240-245. doi: 10.1016/j.jor.2022.09.004. eCollection 2022 Nov-Dec.
- Results publication: PubMed 38276105Aguado-Maestro I, Simon-Perez C, Garcia-Alonso M, Ailagas-De Las Heras JJ, Paredes-Herrero E. Clinical Applications of "In-Hospital" 3D Printing in Hip Surgery: A Systematic Narrative Review. J Clin Med. 2024 Jan 20;13(2):599. doi: 10.3390/jcm13020599.
- Results publication: PubMed 41287497Ryu HG, Kim KH, Ahn SJ, Kim SM. Mid-Term Outcomes of Acetabular Reconstruction Using a Rapid Prototyping Pelvic Model in Complex Total Hip Arthroplasty. Yonsei Med J. 2025 Dec;66(12):851-856. doi: 10.3349/ymj.2025.0001.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Dysplasia of the Hip and Acetabular Bone Loss, 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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 29 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.
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?
Contact Mohamed S El-Zyati, MD (+201061768519, Mohamed-Elzyati@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exact Acetabular Cup Size Prediction Accuracy (time frame: During surgery). 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 NCT07904637, which also lists 6 linked publications.
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 29 Oct 2026.