Evaluation of the Effectiveness of Developmental Hip Dysplasia Screening in Risk Groups

NCT07066852 | Enrolling By Invitation DMC

• 1 other identifier: DDHBilkent
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a non-drug clinical trial. Developmental dysplasia of the hip (DDH) encompasses a spectrum of hip developmental disorders, including dislocation, subluxation, and acetabular dysplasia. DDH is among the most prevalent hip conditions in infants. Dislocation is defined as the incomplete displacement of the hip joint, and residual dislocation due to DDH is associated with pain and severe osteoarthritis of the hip in young adulthood. The progression of DDH is dynamic and may improve or worsen depending on various factors. The primary determinant of prognosis is the concentric reduction of the hip joint, with the femoral head needing to be reduced to allow for normal acetabular development. DDH is the most common orthopedic condition in the neonatal period. According to the literature, the incidence is approximately 1:100 for dysplasia and 1:1000 for dislocation. However, estimates suggest that dislocation rates in Türkiye may reach 5-15:1000. DDH occurs six times more frequently in girls than boys and is more commonly observed in the left hip. Established risk factors for DDH include being a first-born girl, Caucasian race, positive family history, oligohydramnios, multiple pregnancies, in utero breech presentation, pes calcaneovalgus, metatarsus adductus, and torticollis. Early detection and treatment of dislocation caused by DDH are associated with success rates exceeding 80%. However, diagnosis and treatment initiation after one year of age often result in variable outcomes. Literature indicates that clinical and sonographic evaluations may be normal at six weeks in breech patients-who are at significant risk for DDH-yet hip dysplasia may still develop in this population later. The investigators aim to contribute to existing literature by evaluating whether sonographic screening alone is sufficient or if additional screening methods are warranted for patients with identified DDH risk factors.

Conditions

Developmental Dysplasia of Hip

Keywords

acetabulardysplasia; screening; ultrasound; xray; developmentaldysplasiaofhip; PediatricOrthopedics

Outcome Measures

Primary Outcomes (1)

• Acetabular Index Variation Measured by Tönnis Grading System

  The change in acetabular index will be assessed using pelvic anteroposterior(AP) and frog-leg lateral x-rays. Measurements will be analyzed according to the classification system. The unit of measure will be degrees(°).

  At 6 months and 1 year of age

Secondary Outcomes (1)

• Incidence of Pathological Findings on Graf Ultrasonography

  At 6 weeks and 3 months after birth

Study Arms (1)

sample

we use one arm and one sample

Radiation: x ray; Diagnostic Test: ultrasound

Interventions

x ray RADIATION

we performed pelvis ap and frog leg x ray to child in 6 month and 1 age

sample

ultrasound DIAGNOSTIC_TEST

we will perform ultrasound in 6 week and 3 month

sample

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include all children born in the high-risk pregnancy service at our hospital. Participants will be selected randomly, and their families will be informed about the study, providing consent for participation. The study aims to evaluate the effectiveness of developmental hip dysplasia (DDH) screening in high-risk groups in Turkey. Hip ultrasound will be performed six weeks after birth using the Graf method for screening purposes. This examination will include the Ortolani-Barlow test, Galeazzi sign, swaddling, and assessment of any accompanying foot deformities. All ultrasounds will be conducted by a single physician. If any pathology is detected, treatment will be initiated according to current literature. Follow-up evaluations will be conducted at three months, six months, and one year to monitor hip development and assess the acetabular index using Tönnis grading and abduction limitation.

You may qualify if:

• All girls and boys of Turkish origin born in our hospital were included in our study.

You may not qualify if:

• Teratological hip diseases with neuromuscular disorders were excluded from our study. Parents who disrupted follow-up were excluded from the study.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Department of Orthopedics and Traumatology, Bilkent City Hospital, Ankara

Ankara, Ankara, 06340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hip Dislocation

Interventions

X-Rays; Ultrasonography

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mehmet Safa Kapıcıoğlu, Proffesor

  Department of Orthopedics and Traumatology, Bilkent City Hospital, Ankara

  STUDY DIRECTOR

• Mehmet Safa Kapıcıoğlu, Proffesor

  Department of Orthopedics and Traumatology, Bilkent City Hospital, Ankara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Orthopedics and Traumatology Assistant

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: July 15, 2025
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: october 2024-october 2034

Locations

TU (1)