Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05853510
Status:
COMPLETED
Last Update Posted:
2023-05-12
First Post:
2023-05-02
Brief Title:
Mid-term Functional Comparisons of Unilateral and Bilateral Developmental Dysplasia of the Hip
Sponsor:
Pamukkale University
Organization:
Pamukkale University
Study Overview
Official Title:
Are Mid-term Functional Outcomes Different in Unilateral and Bilateral Developmental Dysplasia of the Hip A Cross-sectional Study
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The annual number of live births in Türkiye is 1112859 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 1112859 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None