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

NCT ID: NCT07066852

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-11-01

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.

Detailed Description

Study Overview This study aims to evaluate the effectiveness of developmental dysplasia of the hip (DDH) screening in high-risk pediatric groups in Türkiye.

In Türkiye, all newborns undergo routine hip ultrasonography during the second month of life. If the results are normal, no further hip evaluations are typically performed. However, incidental detection of acetabular dysplasia in children-who later undergo pelvic anteroposterior (AP) X-rays for unrelated reasons-has raised concerns regarding the sufficiency of current screening protocols. Recent studies emphasize that hip development is a dynamic process, with the first 18 months being critical for early intervention. The timely detection of hip dysplasia is essential to minimize long-term physical and psychological burden on patients and healthcare systems. Undiagnosed cases often result in the need for total hip replacement surgery in adulthood. Accordingly, there is a need for a large-scale, prospective study to broaden and enhance the scope of DDH screening, both nationally and globally.

Study Population and Screening Protocol Participants will include all children born in the high-risk pregnancy ward at Ankara Bilkent City Hospital, selected via randomized sampling. After obtaining informed consent from families, hip ultrasonography will be performed six weeks postpartum using the Graf classification method. The screening will include Ortolani-Barlow maneuvers, Galeazzi sign assessment, swaddling practices, and evaluation of associated foot deformities. All sonographic assessments will be conducted by a single, qualified physician.

In cases where pathology is detected, treatment will be initiated in accordance with current medical guidelines. The Graf-based ultrasonography will be repeated at the third month, and follow-up clinical notes will be documented. At six months of age, pelvic AP and frog-leg lateral X-rays will be obtained. The acetabular index will be assessed using the Tönnis grading system, and any limitations in abduction will be recorded. At one year of age, follow-up X-rays will be performed to reassess the acetabular index and Tönnis grade, facilitating longitudinal monitoring of hip development during infancy.

Ethics and Statistical Evaluation Ethics approval for this study was granted by the Ethics Committee of Ankara Bilkent City Hospital (Board No. 1). Power analysis indicated a required sample size of 185 participants to achieve a statistical power of 0.95. This study will be conducted prospectively and analyzed using SPSS version 26.0. Findings will be reported to the Ministry of Health of Türkiye upon study completion.

Conditions

Developmental Dysplasia of Hip

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

sample

we use one arm and one sample

x ray

Intervention Type: RADIATION

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

ultrasound

Intervention Type: DIAGNOSTIC_TEST

we will perform ultrasound in 6 week and 3 month

Interventions

x ray

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

Intervention Type: RADIATION

ultrasound

we will perform ultrasound in 6 week and 3 month

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

KENAN ŞEN

Principal Investigator, Orthopedics and Traumatology Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehmet Safa Kapıcıoğlu, Proffesor

Role: STUDY_DIRECTOR

Department of Orthopedics and Traumatology, Bilkent City Hospital, Ankara

Mehmet Safa Kapıcıoğlu, Proffesor

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopedics and Traumatology, Bilkent City Hospital, Ankara

Locations

Department of Orthopedics and Traumatology, Bilkent City Hospital, Ankara

Ankara, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

DDHBilkent

Identifier Type: -

Identifier Source: org_study_id