Clinical trial NCT03275805: Should Graf IIc Hips be Treated for 12 Weeks
Official title: How Should Stable Graf Type IIc Hips be Treated With Pavlik Harness?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Developmental Dysplasia of Hip
Keywords: DDH
Pavlik Harness
dysplasia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children who are diagnosed with Developmental Hip Dysplasia (DDH) are often categorized depending on the severity of their hip malformation. Regardless of the severity, the accepted form of treatment is the Pavlik Harness. Unfortunately, there is no specific recommended treatment regarding length of Pavlik Harness treatment for patients with DDH who have who have been categorized with stable Graf type IIc hips. The investigators will aim to answer this question with a randomized controlled trial of patients with these specific findings by dividing selected patients into 2 arms. Each arm consists of varying lengths of Pavlik harness treatment (treatment to normalization, no less than 6 weeks or 12 weeks full-time). Patient's two year follow up radiographs will determine the best means of treatment.

Detailed description: Developmental Dysplasia of the Hip is a thoroughly researched and manageable disease if treated correctly. While the literature agrees that Pavlik Harness treatment is the best means of treatment, there is still a lack of research regarding those patients who have stable Graf type IIc hips. Graf's classification method outlines the severity of dysplasia with a categorical method based on physical exam and ultrasound findings with a range of I-IV given in increasing order of severity. There are recommendations for how to treat more severe forms, but there is no consensus among orthopedic surgeons on how to specifically treat type IIc hips who present with stable hips.

Patients ages (0-18 weeks) of age will be recruited who present with stable Graf type IIc hips that have normal exam and abnormal ultrasound. The investigator's designated hip clinic defines normal exam as Ortolani and Barlow negative hips. Alpha angle will be used to determine normalcy on ultrasound. Abnormal ultrasound will be defined as an alpha angle \<60 degrees, and less than 50% coverage and is justification in the facility for entrance into our designated hip protocol.

Upon meeting inclusion/exclusion criteria, patients diagnosed with IIc hips will be placed in the harness around 6 weeks of age. Patient consents will ensue at their 6 week follow up and will randomly divide patients into one of two arms: one control group which will receive the standard 12 week full-time protocol for Pavlik Harness treatment used at the institution, and one experimental group which will receive full-time Pavlik Harness treatment until normalization, but for no less than 6 weeks. All patients will be required to follow up at week 1, 2, 3, 4, 6, 8, 10, and 12, then at 6 months, one year, and two years from the time of harness placement. Ultrasounds will take place at week 1, 2, 3, 4, 6, 8, 10 and 12 and 6 months; radiographs will be taken at patients 6 month, one year and two year follow ups due to ossification of the femoral head. Acetabular Index (AI) at two-year radiographs will be used as the primary outcome variable.

Patients in the 6 week arm will only cease treatment if ultrasound and physical exam findings are acceptable. If patients fail to have acceptable ultrasound findings at 6 weeks, then the associated complication/failure will be noted, patients will be ineligible for study inclusion, and will continue with treatment to ensure hip reduction.

At routine follow ups, providers will note patient alpha angles on ultrasound at weeks 1,2,3,4,6, 8, 10, and 12 weeks. Since infant hips mature and may not be as visible on ultrasound around 6 months of age, acetabular indices on radiographs will be taken to measure patient hips at 6 month, 1 year, and 2 year follow ups. These images will be analyzed from within EPIC after patient visits and data information will be stored in RedCAP until the remainder of the study. Demographic and clinical characteristics will be included through descriptive statistics. Non-inferiority testing between patient's 2 year AI findings will determine if 6 weeks of treatment is no less harmful in terms of incidences of residual dysplasia to that of 12 weeks of treatment. The specified non-inferiority margin will be 4 degrees. This is the chosen clinically accepted difference in AI between groups.

Eligibility criteria: Inclusion Criteria:

1. Patients with:

* DDH
* Graf IIc hips (alpha angle = 43-49 degrees)
* normal hip exam (stable hips)
* abnormal ultrasound

Exclusion Criteria:

1. Patients with additional conditions: Neurologic or teratologic.
2. Follow up that occurs at any other institution.
3. Unstable hips

Primary outcomes:
measure: Acetabular Index at 2 years
timeFrame: 2 year follow up
Secondary outcomes:
Other outcomes:
measure: Cost of Treatment
timeFrame: After conclusion of the 2 year follow up
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Gaia Georgopoulos, MD
role: PRINCIPAL_INVESTIGATOR
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