NCT07581717

Brief Summary

The goal of this observational study is to learn how four acetabular osteotomy techniques change the shape of the hip socket in children and adolescents with developmental dysplasia of the hip or residual acetabular dysplasia. The main questions it aims to answer are: How do virtual Salter, Dega, San Diego, and Pemberton osteotomies differ in acetabular volume and surface shape on participant-specific three-dimensional models? How closely does the virtual result of the osteotomy actually performed match the early postoperative magnetic resonance imaging (MRI)? Participants will have a three-dimensional pelvis-acetabulum model created from preoperative MRI. Researchers will perform virtual Salter, Dega, San Diego, and Pemberton osteotomies on that model and measure the resulting acetabular morphology. The virtual result of the osteotomy actually performed will then be compared with the participant's early postoperative MRI.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
2mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
May 2026Oct 2026

First Submitted

Initial submission to the registry

March 28, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 10, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2026

Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

5 months

First QC Date

March 28, 2026

Last Update Submit

June 24, 2026

Conditions

Keywords

Salter osteotomyDega osteotomySan Diego osteotomyPemberton osteotomyDevelopmental dysplasia of the hipAcetabular dysplasiaMagnetic resonance imagingThree dimensional modelingAcetabular morphometryMethodological validation

Outcome Measures

Primary Outcomes (2)

  • Osteotomy-type differences in simulated acetabular morphometry

    Comparison across virtual Salter, Dega, San Diego, and Pemberton osteotomies of predefined morphometric outputs on participant-specific preoperative 3-dimensional models, including acetabular volume (mm3), surface area (mm2), and angular parameters such as version and inclination (degrees).

    Baseline (preoperative MRI-based virtual simulation, within 6 weeks before surgery)

  • Virtual-to-actual agreement of postoperative acetabular morphometry for the clinically performed osteotomy

    Agreement between the matched virtual osteotomy and the actual postoperative morphology, assessed using predefined morphometric outputs including acetabular volume (mm3), surface area (mm2), and angular parameters such as version and inclination (degrees); summarized using absolute difference, bias, and Bland-Altman limits of agreement.

    Baseline and early postoperative MRI (3 to 8 weeks after surgery)

Secondary Outcomes (5)

  • Osteotomy-type differences in virtual-to-actual prediction error

    Baseline and early postoperative MRI (3 to 8 weeks after surgery)

  • Interobserver reliability of MRI-based segmentation and morphometric measurements

    Baseline and early postoperative MRI (3 to 8 weeks after surgery)

  • Intraobserver reliability of MRI-based segmentation and morphometric measurements

    Baseline and early postoperative MRI (3 to 8 weeks after surgery)

  • Workflow processing time

    From baseline MRI acquisition to completion of early postoperative MRI analysis, up to 14 weeks

  • Workflow completion rate

    From baseline MRI acquisition to completion of early postoperative MRI analysis, up to 14 weeks

Study Arms (4)

Salter Osteotomy Cohort

Participants with DDH or residual acetabular dysplasia undergoing primary Salter acetabular osteotomy as part of routine clinical care, with preoperative MRI-based 3D modeling and early postoperative MRI comparison.

Procedure: Salter osteotomy

Dega Osteotomy Cohort

Participants with DDH or residual acetabular dysplasia undergoing primary Dega acetabular osteotomy as part of routine clinical care, with preoperative MRI-based 3D modeling and early postoperative MRI comparison.

Procedure: Dega osteotomy

San Diego Osteotomy Cohort

Participants with DDH or residual acetabular dysplasia undergoing primary San Diego acetabular osteotomy as part of routine clinical care, with preoperative MRI-based 3D modeling and early postoperative MRI comparison.

Procedure: San Diego osteotomy

Pemberton Osteotomy Cohort

Participants with DDH or residual acetabular dysplasia undergoing primary Pemberton acetabular osteotomy as part of routine clinical care, with preoperative MRI-based 3D modeling and early postoperative MRI comparison.

Procedure: Pemberton osteotomy

Interventions

Redirectional innominate osteotomy performed to improve acetabular orientation and femoral head coverage in children and adolescents with developmental dysplasia of the hip or residual acetabular dysplasia. The acetabulum is reoriented as a single fragment to increase primarily anterolateral coverage. The procedure is performed as routine clinical care, with technique selection based on the treating surgeon's indication and preoperative deformity pattern.

Also known as: Salter innominate osteotomy
Salter Osteotomy Cohort

Incomplete transiliac acetabuloplasty performed to reshape the acetabular roof and improve femoral head coverage in children and adolescents with developmental dysplasia of the hip or residual acetabular dysplasia. The osteotomy preserves a hinge at the triradiate cartilage, allowing tailored correction of acetabular deficiency according to the morphology of the dysplastic socket. The procedure is performed as routine clinical care, with technique selection based on the treating surgeon's indication and preoperative deformity pattern.

Also known as: Dega acetabuloplasty
Dega Osteotomy Cohort

Pericapsular acetabuloplasty performed to reshape and redirect the acetabulum in children and adolescents with developmental dysplasia of the hip or residual acetabular dysplasia. The osteotomy uses the triradiate cartilage as a hinge and increases femoral head coverage by altering acetabular shape and orientation. The procedure is performed as routine clinical care, with technique selection based on the treating surgeon's indication and preoperative deformity pattern.

Also known as: Pemberton pericapsular osteotomy
Pemberton Osteotomy Cohort

Incomplete transiliac acetabuloplasty performed to improve acetabular coverage in children and adolescents with developmental dysplasia of the hip or residual acetabular dysplasia. The procedure preserves a triradiate cartilage hinge and allows directional correction according to the location of acetabular deficiency, including posterolateral or lateral deficiency when appropriate. The procedure is performed as routine clinical care, with technique selection based on the treating surgeon's indication and preoperative deformity pattern.

Also known as: San Diego acetabuloplasty
San Diego Osteotomy Cohort

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children and adolescents with developmental dysplasia of the hip or residual acetabular dysplasia who are scheduled for primary Salter, Dega, San Diego, or Pemberton acetabular osteotomy at Istanbul University, Istanbul Faculty of Medicine

You may qualify if:

  • Age 2 to 18 years
  • Developmental dysplasia of the hip or residual acetabular dysplasia
  • Primary Salter, Dega, San Diego, or Pemberton acetabular osteotomy planned at Istanbul University, Istanbul Faculty of Medicine
  • Preoperative hip MRI available within 6 weeks before surgery
  • Early postoperative hip MRI available 3 to 8 weeks after surgery
  • MRI quality adequate for three-dimensional morphometric analysis
  • Unilateral or bilateral cases eligible

You may not qualify if:

  • Hip pathology not related to developmental dysplasia of the hip, including Perthes disease, slipped capital femoral epiphysis, neuromuscular dysplasia, or infection/trauma sequelae
  • Previous surgery on the same hip that significantly alters anatomy, including prior pelvic or femoral osteotomy or open reduction, or current metal implant/fusion
  • MRI contraindication or safety issue, including MR-incompatible implant/device, severe claustrophobia, or a medical barrier to sedation/anesthesia
  • MRI not compatible with protocol or inadequate for analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Related Publications (7)

  • du Cluzel de Remaurin X, Khouri N, Georges S, Gajny L, Vergari C, Badina A. Methods for three-dimensional characterization of the acetabulum prior to pelvic reorientation osteotomy: a scoping review. EFORT Open Rev. 2024 Aug 1;9(8):762-772. doi: 10.1530/EOR-22-0126.

    PMID: 39087510BACKGROUND
  • Badrinath R, Jeffords ME, Bomar JD, Ahmed SI, Pennock AT, Upasani VV. 3D Characterization of Acetabular Deficiency in Children with Developmental Dysplasia of the Hip. Indian J Orthop. 2021 Jul 23;55(6):1576-1582. doi: 10.1007/s43465-021-00458-7. eCollection 2020 Dec.

    PMID: 34987728BACKGROUND
  • van Bosse H, Wedge JH, Babyn P. How are dysplastic hips different? A three-dimensional CT study. Clin Orthop Relat Res. 2015 May;473(5):1712-23. doi: 10.1007/s11999-014-4103-y. Epub 2014 Dec 19.

    PMID: 25524428BACKGROUND
  • Caffrey JP, Jeffords ME, Farnsworth CL, Bomar JD, Upasani VV. Comparison of 3 Pediatric Pelvic Osteotomies for Acetabular Dysplasia Using Patient-specific 3D-printed Models. J Pediatr Orthop. 2019 Mar;39(3):e159-e164. doi: 10.1097/BPO.0000000000001271.

    PMID: 30300278BACKGROUND
  • Zeng G, Schmaranzer F, Degonda C, Gerber N, Gerber K, Tannast M, Burger J, Siebenrock KA, Zheng G, Lerch TD. MRI-based 3D models of the hip joint enables radiation-free computer-assisted planning of periacetabular osteotomy for treatment of hip dysplasia using deep learning for automatic segmentation. Eur J Radiol Open. 2020 Dec 18;8:100303. doi: 10.1016/j.ejro.2020.100303. eCollection 2021.

    PMID: 33364259BACKGROUND
  • Nakamura T, Wada A, Natori T, Kawaguchi K, Takamura K, Yanagida H, Yamaguchi T. A Novel Method for Assessing the 3-dimensional Morphology of Cartilaginous Acetabulum Via Childhood Magnetic Resonance Imaging. J Pediatr Orthop. 2023 Nov-Dec 01;43(10):640-648. doi: 10.1097/BPO.0000000000002510. Epub 2023 Sep 8.

    PMID: 37681305BACKGROUND
  • Bellova P, Blum S, Hartmann A, Thielemann F, Gunther KP, Goronzy J. MRI-based assessment of acetabular version and coverage after previous Pemberton osteotomy in skeletally mature patients. J Child Orthop. 2021 Jun 1;15(3):223-231. doi: 10.1302/1863-2548.15.210010.

    PMID: 34211598BACKGROUND

MeSH Terms

Conditions

Developmental Dysplasia of the HipHip Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and InjuriesHip Injuries

Study Officials

  • Yavuz Sağlam, M.D.

    Istanbul University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Orthopedics and Traumatology

Study Record Dates

First Submitted

March 28, 2026

First Posted

May 12, 2026

Study Start

May 10, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 15, 2026

Last Updated

June 26, 2026

Record last verified: 2026-06

Locations