NCT05853510

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

Completed Last updated 12 May 2023

What this trial tests

trial in Developmental Dysplasia of the Hip in 35 participants. Completed in 11 September 2022.

Timeline

11 November 2021

Primary endpoint
11 February 2022

11 September 2022

Quick facts

Lead sponsor	Pamukkale University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	35
Start date	11 November 2021
Primary completion	11 February 2022
Estimated completion	11 September 2022
Sites	1 location across Turkey (Türkiye)

Conditions studied

• Developmental Dysplasia of the Hip — all drugs for Developmental Dysplasia of the Hip →

Sponsor

Pamukkale University

Who can join

Adults 5 to 10, any sex, with Developmental Dysplasia of the Hip. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.