Clinical trial NCT05853510: Mid-term Functional Comparisons of Unilateral and Bilateral Developmental Dysplasia of the Hip
Official title: Are Mid-term Functional Outcomes Different in Unilateral and Bilateral Developmental Dysplasia of the Hip? A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Developmental Dysplasia of the Hip
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 35
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were treated with hip abduction brace in the orthopedics and traumatology department of a university hospital from January 2010 to January 2016 were screened from the hospital registry system. Eligible 72 patients were contacted by telephone and invited to participate in the present study and 54 patients agreed to participate. A total of 35 patients were able to complete all assessments and their data were analyzed. 16 patients had unilateral and 19 patients had bilateral developmental dysplasia of the hip.

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.

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.

Primary outcomes:
measure: Radiographs
timeFrame: 2 hours
measure: Lower Extremity Functional Scale
timeFrame: 30 minutes
measure: 10 meters walking test
timeFrame: 10 minutes
measure: Double-leg vertical jump test
timeFrame: 15 minutes
measure: Jump rope
timeFrame: 10 minutes
measure: STAR excursion balance test
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Raziye Şavkın, Dr
role: PRINCIPAL_INVESTIGATOR
References: