Pavlik Harness Duration for Developmental Hip Dysplasia

Recruiting in Palo Alto (17 mi)

Overseen by Gaia Georgopoulos, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Colorado, Denver

Disqualifiers: Neurologic, Teratologic, Unstable hips, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the Pavlik Harness treatment for developmental hip dysplasia?

Research shows that the Pavlik Harness is effective in treating developmental dysplasia of the hip (DDH) in infants, with a high success rate in reducing dislocated hips and improving hip stability, especially when used early in treatment. However, its effectiveness varies with the severity of the condition, being more successful in less severe cases. ^{1 2 3 4 5}

Is the Pavlik Harness safe for treating developmental hip dysplasia in infants?

The Pavlik Harness is generally safe for treating developmental hip dysplasia in infants, but there is a risk of avascular necrosis (a condition where bone tissue dies due to lack of blood supply) in some cases. No complications were reported with the use of an abduction brace after Pavlik Harness failure. ^{1 3 4 6 7}

How does the Pavlik harness treatment for developmental hip dysplasia differ from other treatments?

The Pavlik harness is unique because it is a non-surgical treatment that uses a soft brace to hold a baby's hips in the correct position, allowing for natural development. It is the standard initial treatment for infants under 6 months with developmental dysplasia of the hip, and parents are taught to apply it at home, which is crucial for its success. ^{2 3 4 8 9}

Research Team

Gaia Georgopoulos, MD

Principal Investigator

Children's Hospital Colorado

Eligibility Criteria

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.

Inclusion Criteria

My hips are stable and healthy.

I have developmental dysplasia of the hip.

Patients with Graf IIc hips (alpha angle = 43-49 degrees)

Exclusion Criteria

Follow up that occurs at any other institution

My hips are unstable.

Patients with additional conditions: Neurologic or teratologic

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Pavlik Harness treatment for either 6 weeks or 12 weeks, depending on the assigned arm

6-12 weeks

Weekly visits for 12 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with radiographs at 6 months, 1 year, and 2 years

2 years

3 visits (in-person) at 6 months, 1 year, and 2 years

Treatment Details

Interventions

• 12 week standard of care (Behavioural Intervention)
• Duration of Pavlik Harness treatment (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: 6 weeks Pavlik Treatment Arm Experimental Treatment 1 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 Arm Active Control 1 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.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Aviva Abosch

University of Colorado, Denver

Chief Medical Officer since 2019

MD

Uday B. Kompella

University of Colorado, Denver

Chief Executive Officer since 2015

PhD in Pharmaceutical Sciences

Findings from Research

Infants treated with a Pavlik harness for developmental dysplasia of the hip achieved several early motor milestones later than healthy infants, specifically in rolling and sitting, with significant delays noted in four milestones.

Despite these delays being statistically significant, they were not considered clinically significant, and no differences were found in later motor milestones, suggesting that Pavlik harness treatment does not adversely affect overall motor development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No Delay in Age of Crawling, Standing or Walking with Pavlik Harness Treatment: A Prospective Cohort Study. Stavinoha, TJ., Pun, SY., McGlothlin, JD., et al.[2023]

In a study of 50 infants with developmental dysplasia of the hip, the Pavlik harness was effective in successfully reducing type-III hips in 73.8% of cases, but only 20% for type-IV hips, indicating varying efficacy based on hip classification.

While prolonged treatment with the Pavlik harness can be beneficial for type-III hips, it may delay necessary surgical interventions for type-IV hips, suggesting that its use in this group should be reconsidered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged treatment with the Pavlik harness in infants with developmental dysplasia of the hip. van der Sluijs, JA., De Gier, L., Verbeke, JI., et al.[2022]

Shortening the time to the first routine follow-up ultrasound from 12 weeks to 6 weeks after starting Pavlik harness treatment significantly reduced the median treatment duration from 12 weeks to 6.1 weeks, indicating a more efficient monitoring approach.

The study found that while the earlier ultrasound did not significantly increase the risk of residual dysplasia at 1 year, infants with a positive family history of developmental dysplasia of the hip and a lower initial alpha angle were more likely to have a higher acetabular index at that age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timing of Repeat Ultrasound Examination in Treatment of Stable Developmental Dysplasia of the Hip. Theunissen, WWES., van der Steen, M., van Douveren, FQMP., et al.[2023]

In a study of 18 infants with severe developmental dysplasia of the hip (DDH), treatment using a Pavlik harness followed by an abduction brace resulted in a 95.4% success rate, indicating its efficacy in correcting hip dislocations.

The study highlighted that while the Pavlik harness is generally safe, there were instances of type I avascular necrosis in two hips, emphasizing the importance of careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of developmental dysplasia of the hip with Pavlik harness: prospective study in Graf type IIc or more severe hips. Uçar, DH., Işiklar, ZU., Kandemir, U., et al.[2022]

In a review of 15 infants with developmental dysplasia of the hip (DDH) who did not respond to Pavlik harness treatment, 13 infants successfully resolved their condition using an abduction brace, with an average stabilization time of 24 days.

The use of the abduction brace was safe, with no complications reported, and at an average follow-up of 3 years and 7 months, none of the patients required surgery or experienced residual hip issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of an abduction brace for developmental dysplasia of the hip after failure of Pavlik harness use. Hedequist, D., Kasser, J., Emans, J.[2022]

In a study of 31 infants with late-diagnosed hip dislocation treated with the Pavlik harness, 65% achieved successful hip reduction, particularly those classified as Tönnis type 2, where the success rate was 81%.

While the use of an abduction brace after successful reduction showed improvement in the acetabular index, its additional benefit remains uncertain due to the lack of a control group in the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful Pavlik treatment in late-diagnosed developmental dysplasia of the hip. van de Sande, MA., Melisie, F.[2022]

In a study of 55 hips from 46 infants treated with the Pavlik harness for developmental dysplasia of the hip, a significant inverse correlation was found between the initial alpha angle and the duration of treatment, indicating that a higher alpha angle may lead to a shorter treatment time.

Bilateral hip involvement was associated with a longer duration of treatment compared to unilateral cases, suggesting that the complexity of the condition can impact how long the harness needs to be worn.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An analysis of variables affecting the duration of Pavlik harness treatment: Is it possible to predict the duration of treatment? Salduz, A., Demirel, M., Akgül, T., et al.[2019]

A simulated learning module significantly improved parents' skills in applying the Pavlik harness, with their performance reaching the level of expert clinicians immediately after training and one month later.

Despite the improvement in technical skills, only half of the parents were deemed competent in achieving the required hip positions, indicating that ongoing clinician supervision is necessary for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education of parents in Pavlik harness application for developmental dysplasia of the hip using a validated simulated learning module. Gargan, KE., Bradley, CS., Maxwell, A., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Acetabular index as an indicator of Pavlik harness success in grade I developmental dysplasia of the hip: A retrospective study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

No Delay in Age of Crawling, Standing or Walking with Pavlik Harness Treatment: A Prospective Cohort Study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Prolonged treatment with the Pavlik harness in infants with developmental dysplasia of the hip. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Timing of Repeat Ultrasound Examination in Treatment of Stable Developmental Dysplasia of the Hip. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment of developmental dysplasia of the hip with Pavlik harness: prospective study in Graf type IIc or more severe hips. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Use of an abduction brace for developmental dysplasia of the hip after failure of Pavlik harness use. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Successful Pavlik treatment in late-diagnosed developmental dysplasia of the hip. [2022]

8. France pubmed.ncbi.nlm.nih.gov

An analysis of variables affecting the duration of Pavlik harness treatment: Is it possible to predict the duration of treatment? [2019]

9. England pubmed.ncbi.nlm.nih.gov

Education of parents in Pavlik harness application for developmental dysplasia of the hip using a validated simulated learning module. [2022]