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Computer-Assisted Comparison of Hip Socket Volume and Surface Shape After Pediatric Acetabular Osteotomies (PAVMS)

24 giugno 2026 aggiornato da: Yavuz Saglam, Istanbul University

Computer-Assisted Comparative Analysis of Acetabular Volume and Surface Morphology in Pediatric Acetabular Osteotomies (Salter, Dega, San Diego, and Pemberton)

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a single-center, prospective, observational methodological validation study in children and adolescents with developmental dysplasia of the hip or residual acetabular dysplasia who are undergoing Salter, Dega, San Diego, or Pemberton acetabular osteotomy.

The study has two linked analytical components. First, participant-specific three-dimensional pelvis-acetabulum models will be generated from preoperative MRI obtained within 6 weeks before surgery. Standardized virtual Salter, Dega, San Diego, and Pemberton osteotomies will then be applied on each participant's preoperative model to compare the expected effect of each technique on acetabular volume, surface area, coverage distribution, and other predefined three-dimensional morphometric parameters.

Second, early postoperative MRI obtained 3 to 8 weeks after surgery will be used to derive actual postoperative three-dimensional morphology. The virtual output corresponding to the osteotomy actually performed clinically will then be compared with the postoperative MRI-derived morphology to quantify prediction accuracy using absolute difference, bias, and Bland-Altman limits of agreement.

Additional analyses will compare validation performance by osteotomy type, assess interobserver and intraobserver reliability, measure workflow feasibility, and explore associations between preoperative morphometric markers and prediction error.

Tipo di studio

Osservativo

Iscrizione (Stimato)

12

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Turchia (Türkiye)
      • Istanbul, Turchia (Türkiye), 34093
        • Reclutamento
        • Istanbul University, Istanbul Faculty of Medicine, Department of Orthopedics and Traumatology
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Yavuz Sağlam, M.D.
        • Sub-investigatore:
          • İsmail T. Atasoy, M.D.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

Inclusion Criteria:

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

Exclusion Criteria:

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Procedura: Salter osteotomy
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.
Altri nomi:
  • Salter innominate 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.
Procedura: Dega osteotomy
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.
Altri nomi:
  • Dega acetabuloplasty
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.
Procedura: San Diego osteotomy
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.
Altri nomi:
  • San Diego acetabuloplasty
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.
Procedura: Pemberton osteotomy
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.
Altri nomi:
  • Pemberton pericapsular osteotomy

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Osteotomy-type differences in simulated acetabular morphometry
Lasso di tempo: Baseline (preoperative MRI-based virtual simulation, within 6 weeks before surgery)
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
Lasso di tempo: Baseline and early postoperative MRI (3 to 8 weeks after surgery)
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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Osteotomy-type differences in virtual-to-actual prediction error
Lasso di tempo: Baseline and early postoperative MRI (3 to 8 weeks after surgery)
Comparison of validation error among clinically performed Salter, Dega, San Diego, and Pemberton osteotomies.
Baseline and early postoperative MRI (3 to 8 weeks after surgery)
Interobserver reliability of MRI-based segmentation and morphometric measurements
Lasso di tempo: Baseline and early postoperative MRI (3 to 8 weeks after surgery)
Interobserver agreement for segmentation and morphometric measurements, reported using intraclass correlation coefficients.
Baseline and early postoperative MRI (3 to 8 weeks after surgery)
Intraobserver reliability of MRI-based segmentation and morphometric measurements
Lasso di tempo: Baseline and early postoperative MRI (3 to 8 weeks after surgery)
Intraobserver agreement for repeat measurements, reported using intraclass correlation coefficients.
Baseline and early postoperative MRI (3 to 8 weeks after surgery)
Workflow processing time
Lasso di tempo: From baseline MRI acquisition to completion of early postoperative MRI analysis, up to 14 weeks
Time required for segmentation, virtual osteotomy simulation, and morphometric analysis.
From baseline MRI acquisition to completion of early postoperative MRI analysis, up to 14 weeks
Workflow completion rate
Lasso di tempo: From baseline MRI acquisition to completion of early postoperative MRI analysis, up to 14 weeks
Proportion of enrolled participants with a complete protocol-compatible analyzable dataset.
From baseline MRI acquisition to completion of early postoperative MRI analysis, up to 14 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Istanbul University

Investigatori

  • Investigatore principale: Yavuz Sağlam, M.D., Istanbul University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 maggio 2026

Completamento primario (Stimato)

30 settembre 2026

Completamento dello studio (Stimato)

15 ottobre 2026

Date di iscrizione allo studio

Primo inviato

28 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 maggio 2026

Primo Inserito (Effettivo)

12 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2025/1914

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

De-identified individual participant data are not planned to be shared with other researchers. Any future sharing would require additional review of participant confidentiality protections, institutional policy, and ethics approval. Aggregate study results may be reported in scientific publications and presentations.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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