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

Are Mid-term Functional Outcomes Different in Unilateral and Bilateral Developmental Dysplasia of the Hip? A Cross-sectional Study

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.

Study Overview

• Status: Completed
• Conditions: Developmental Dysplasia of the Hip

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.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey, 20160
    • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Unilateral developmental dysplasia of the hip; Diagnosed with developmental dysplasia of the hip and treated with a hip abduction brace in one hip.
Bilateral developmental dysplasia of the hip; Diagnosed with developmental dysplasia of the hip and treated with a hip abduction brace in two hips.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographs	Standard pelvic AP radiographs taken at the first and last admission of the patients were used for radiological evaluation. The acetabular index angle of Hilgenreiner and the centeredge angle of Wiberg were measured. The Tönnis radiographic classification was used for patients with ossified femoral head, and the IHDI classification was used for other patients.	2 hours
Lower Extremity Functional Scale	Lower Extremity Functional Scale was used for assess functional status in musculoskeletal dysfunction affecting the lower extremities. The scale mainly consists of 20-items and is a 5-point Likert type (0 = extreme difficulty or or unable to perform activity and 4 = no difficulty). Total score ranged from 0 to 80 points, with higher scores indicating better functional status.	30 minutes
10 meters walking test	10 meters walking test was used for assessing the walking speed over a distance of 10 meters	10 minutes
Double-leg vertical jump test	The double-leg vertical jump test was used to determine the strength and functional characteristics of the lower extremity extensor muscles. Participants stood upright with feet positioned shoulder width apart, and hands at their hips (to reduce the impact of arm movement). Patients were instructed to jump as high as possible with both legs.	15 minutes
Jump rope	Jump rope assesses the strength of the lower extremity muscles. Patients were asked to jump rope for 60 seconds and the number of repetitions was recorded	10 minutes
STAR excursion balance test	STAR excursion balance test was used to measure dynamic balance in children. The test was performed with both extremities. In order to reduce the time required to perform the test, reach in 3 directions was measured anterior, posteromedial, and posterolateral, respectively. To normalize the distances reached, the reach distance was divided by the leg length and multiplied by 100.	10 minutes

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Principal Investigator: Raziye Şavkın, Dr, Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Actual): February 11, 2022
• Study Completion (Actual): September 11, 2022

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Joint Dislocations; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital
• Other Study ID Numbers: 60116787-020-125130/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No