Mid-term Functional Comparisons of Unilateral and Bilateral Developmental Dysplasia of the Hip

NCT ID: NCT05853510

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-11
• Study Completion Date: 2022-09-11

Brief Summary

The annual number of live births in Türkiye is 1,112,859 in 2020 and the estimated incidence of developmental dysplasia of the hip (DDH) is between 5 and 15 per 1000 live births. The implementation of the National DDH Early Diagnosis and Treatment Program by the Türkiye Republic of the Ministry of Health in 2010 significantly reduced the number of patients with DDH diagnosed more than 6 months later. If not appropriately treated, DDH can cause a decrease in the number of healthy life years, and workforce losses, which consequently burdens the social security system and government budget. The vast majority of clinical trials comprise risk factors associated with complications after treatment of DDH. Moreover, studies involving functional assessments are generally focused on adult DDH patients with surgical indications. To the best of the investigators' knowledge, mid-term patient-reported and performance-based functionality has not been examined in conservatively treated patients. In addition, it is not known whether the diagnosis of unilateral and bilateral DDH in these patients will make a difference in daily activities which require bilateral functionality of the lower limbs. Therefore, in this study, the investigators examined and compared the mid-term patient-reported and performance-based functional outcomes in patients with unilateral and bilateral DDH treated with a hip abduction brace. This study provides new data on mid-term functionality in children with unilateral and bilateral DDH. It can guide determining the lower extremity functional levels of school-age children with DDH, regular follow-up, early diagnosis, and treatment planning for problems.

Detailed Description

The annual number of live births in Türkiye is 1,112,859 in 2020 and the estimated incidence of developmental dysplasia of the hip (DDH) is between 5 and 15 per 1000 live births. The implementation of the National DDH Early Diagnosis and Treatment Program by the Türkiye Republic of the Ministry of Health in 2010 significantly reduced the number of patients with DDH diagnosed more than 6 months later. If not appropriately treated, DDH can cause a decrease in the number of healthy life years, and workforce losses, which consequently burdens the social security system and government budget. The vast majority of clinical trials comprise risk factors associated with complications after treatment of DDH. Moreover, studies involving functional assessments are generally focused on adult DDH patients with surgical indications. To the best of the investigators' knowledge, mid-term patient-reported and performance-based functionality has not been examined in conservatively treated patients. In addition, it is not known whether the diagnosis of unilateral and bilateral DDH in these patients will make a difference in Daily activities which require bilateral functionality of the lower limbs. Therefore, in this study, the investigators examined and compared the mid-term patient-reported and performance-based functional outcomes in patients with unilateral and bilateral DDH treated with a hip abduction brace. This study provides new data on mid-term functionality in children with unilateral and bilateral DDH. It can guide determining the lower extremity functional levels of school-age children with DDH, regular follow-up, early diagnosis, and treatment planning for problems.

The vast majority of clinical trials comprise risk factors associated with complications after treatment of DDH. Moreover, studies involving functional assessments are generally focused on adult DDH patients with surgical indications. To the best of the investigators' knowledge, mid-term patient-reported and performance-based functionality has not been examined in conservatively treated patients. In addition, it is not known whether the diagnosis of unilateral and bilateral DDH in these patients will make a difference in activities such as jumping rope, double-leg jumping, walking, and dynamic balance, which require bilateral functionality of the lower limbs. Therefore, the aim of this study is to examine and compare the mid-term patient-reported and performance-based functional outcomes in patients with unilateral and bilateral DDH treated with a hip abduction brace.

Conditions

Developmental Dysplasia of the Hip

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Unilateral developmental dysplasia of the hip

Diagnosed with developmental dysplasia of the hip and treated with a hip abduction brace in one hip.

No interventions assigned to this group

Bilateral developmental dysplasia of the hip

Diagnosed with developmental dysplasia of the hip and treated with a hip abduction brace in two hips.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• diagnosed with developmental dysplasia of the hip and treated with a hip abduction brace

Exclusion Criteria

• teratological hip dislocations,
• hip avascular necrosis,
• comorbid disease such as cerebral palsy, myelomeningocele, hypoxic encephalopathy, muscular dystrophy and leukoencephalopathy,
• receiving different treatments before.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Raziye Şavkın

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raziye Şavkın, Dr

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Locations

Pamukkale University

Denizli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

60116787-020-125130/20

Identifier Type: -

Identifier Source: org_study_id