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

NCT05853510 | Completed DMC

• 1 other identifier: 60116787-020-125130/20
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Developmental Dysplasia of the Hip

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, 20160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Developmental Dysplasia of the Hip

Condition Hierarchy (Ancestors)

Hip Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Raziye Şavkın, Dr

  Pamukkale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 10, 2023
• Study Start: November 11, 2021
• Primary Completion: February 11, 2022
• Study Completion: September 11, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)