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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 year follow up

Awards & highlights

Study Summary

This trial is investigating whether a shorter or longer treatment with the Pavlik Harness is better for children with Developmental Hip Dysplasia who have stable Graf type IIc hips.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Erythrocyte Indices

Other outcome measures

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,426 Total Patients Enrolled

Gaia Georgopoulos, MDPrincipal InvestigatorChildren's Hospital Colorado

Media Library

Duration of Pavlik Harness treatment Clinical Trial Eligibility Overview. Trial Name: NCT03275805 — N/A

Developmental Dysplasia of the Hip Research Study Groups: 12 weeks Pavlik Treatment Arm, 6 weeks Pavlik Treatment Arm

Developmental Dysplasia of the Hip Clinical Trial 2023: Duration of Pavlik Harness treatment Highlights & Side Effects. Trial Name: NCT03275805 — N/A

Duration of Pavlik Harness treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT03275805 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does enrollment for this experiment remain open at this time?

"Positive. Details hosted on clinicaltrials.gov signify that this medical investigation has been accepting participants since June 11th 2021 and is still actively searching for them today. A total of 100 individuals are required, with enrolment limited to 1 specific location."

Answered by AI

Does the age of an individual preclude them from participating in this scientific exploration?

"The eligibility requirements for this research specify that participants ought to be between 0 and 18 weeks of age."

Answered by AI

Is my eligibility sufficient to partake in this examination?

"This trial will accept 100 infants with developmental dysplasia of the hip between 0 and 18 weeks old, provided they have an abnormal ultrasound."

Answered by AI

What is the projected enrollment of participants for this research study?

"Affirmative, clinicaltrials.gov confirms that this medical experiment is currently searching for research subjects. This study was first posted on June 11th 2021 and recently updated on August 12th 2022. There are 100 slots available at a single trial location."

Answered by AI

Recent research and studies

Archives of Orthopaedic and Traumatic SurgeryJournal

Classification of Hip Joint Dysplasia by Means of Sonography

Graf, R.. 1984. “Classification of Hip Joint Dysplasia by Means of Sonography”. Archives of Orthopaedic and Traumatic Surgery. Springer Science and Business Media LLC. doi:10.1007/bf00436138.

The Journal of Bone and Joint SurgeryJournal

Ilfeld Abduction Orthosis Is an Effective Second-line Treatment After Failure of Pavlik Harness for Infants with Developmental Dysplasia of the Hip

Sankar, Wudbhav N., Afamefuna Nduaguba, and John M. Flynn. 2015. “Ilfeld Abduction Orthosis Is an Effective Second-line Treatment After Failure of Pavlik Harness for Infants with Developmental Dysplasia of the Hip”. The Journal of Bone and Joint Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.n.00707.

Journal of Pediatric OrthopedicsJournal

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Mostert, Adriaan, Niek Tulp, and Rene Castelein. 2002. “[]”. Journal of Pediatric Orthopedics. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00004694-200205000-00029.

Journal of the American Academy of Physician AssistantsJournal