What side effects are associated with this type of intervention?

The Pavlik Harness, used to treat Developmental Dysplasia of the Hip (DDH), is generally well-tolerated but can have some side effects. Common issues include skin irritation or sores due to the harness straps, and in rare cases, femoral nerve palsy, which can cause temporary weakness or loss of movement in the leg. Proper fitting and regular monitoring by healthcare providers can help minimize these risks.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for Developmental Dysplasia of the Hip (DDH) in the provided context. The Pavlik Harness, which maintains the hip in flexion and abduction to promote proper hip joint development, is a commonly accepted form of treatment for DDH. However, the context does not provide information on FDA approvals for this or similar treatments.

What other types of research exist?

One promising novel alternative to the Pavlik Harness for treating Developmental Dysplasia of the Hip (DDH) is the use of anterior vertebral body tethering (AVBT). This method has shown potential in recent studies for managing skeletal growth and correcting spinal deformities, which could be adapted for hip dysplasia treatment. Additionally, advancements in 3D ultrasound imaging techniques may enhance early diagnosis and treatment planning, potentially leading to the development of new, more effective orthotic devices or minimally invasive surgical options.

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Pavlik Harness Duration for Developmental Hip Dysplasia

N/A

Recruiting

Led By Gaia Georgopoulos, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with normal hip exam (stable hips)

Patients with DDH

Must not have

Patients with unstable hips

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 year follow up

Awards & highlights

Summary

This trial aims to determine the best duration for using the Pavlik Harness in infants with a specific type of hip malformation. The harness helps their hips develop correctly by keeping them in the right position. Infants will be treated for different periods, and their hip development will be monitored over time. The Pavlik harness has been widely used for many years to treat developmental dysplasia of the hip (DDH) in infants up to 6 months old.

Who is the study for?

This trial is for children with a mild form of hip dysplasia (Graf IIc hips) who have stable hips on examination. They must have been diagnosed with DDH and shown abnormal results on an ultrasound. Children are not eligible if they have neurological or teratologic conditions, unstable hips, or if they will receive follow-up care at a different institution.

What is being tested?

The study is testing how long to use the Pavlik Harness, which is a standard treatment for developmental hip dysplasia in children. Participants will be randomly assigned to two groups: one receiving the harness treatment until their condition normalizes but no less than 6 weeks, and another group wearing it for a full 12 weeks.

What are the potential side effects?

While the trial description does not specify side effects, typical concerns with Pavlik Harness use include potential skin irritation, difficulty with diaper changes and bathing due to the harness setup.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My hips are stable and healthy.

Select...

I have developmental dysplasia of the hip.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My hips are unstable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 year follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 year follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Erythrocyte Indices

Other study objectives

Cost of Treatment

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 6 weeks Pavlik Treatment ArmExperimental Treatment1 Intervention

This arm will receive treatment to normalization, but for no less than 6 weeks. Patients will begin their treatment around the time of their first visit to our designated hip clinic.

Group II: 12 weeks Pavlik Treatment ArmActive Control1 Intervention

This arm will receive 12 weeks of full-time Pavlik Harness treatment. Patients will most likely begin the 12-week regiment at their first visit to our hip clinic.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Pavlik Harness, a common treatment for Developmental Dysplasia of the Hip (DDH), works by maintaining the hip in flexion and abduction. This positioning ensures that the femoral head remains properly seated within the acetabulum, promoting natural molding and deepening of the hip socket. This mechanism is crucial for proper hip joint development, reducing the risk of long-term complications and the need for more invasive treatments.