Pavlik Harness Duration for Developmental Hip Dysplasia

Overseen By Gaia Georgopoulos, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Neurologic, Teratologic, Unstable hips, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 6-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal duration for wearing a Pavlik Harness in children with Developmental Hip Dysplasia (DDH). The Pavlik Harness, a soft brace, holds the hips in the correct position to aid proper development. Researchers will compare two groups: one wearing the harness for at least 6 weeks and another for 12 weeks. The trial seeks children with stable hips but specific ultrasound signs. It aims to determine the most effective treatment duration by assessing hip development after two years. As an unphased trial, this study provides a unique opportunity to enhance understanding of the optimal treatment duration for DDH in children.

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 prior data suggests that the Pavlik Harness is safe for treating developmental hip dysplasia?

Research has shown that the Pavlik harness, used to treat hip issues in children, is generally safe. Studies indicate that this treatment does not cause major delays in a child's development. Although some risk factors, such as family history or being female, may affect the treatment's effectiveness, they do not impact its safety.

The Pavlik harness is a well-known and accepted method for managing hip problems in children. It works by keeping the baby's hips in the correct position to aid proper development. Most evidence suggests that using the Pavlik harness does not lead to major safety concerns. Parents can feel reassured about the safety of this treatment for their children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the optimal duration for using the Pavlik Harness in treating developmental hip dysplasia, potentially improving outcomes for infants. Unlike the standard care, which often involves a fixed treatment period, this trial investigates whether a shorter, more personalized treatment duration might be just as effective. By comparing a 12-week treatment arm with a flexible 6-week arm, the trial aims to identify whether a shorter duration can still achieve hip normalization, potentially reducing discomfort and inconvenience for both infants and their caregivers.

What evidence suggests that this trial's treatments could be effective for developmental hip dysplasia?

This trial will compare two durations of Pavlik harness treatment for developmental hip dysplasia (DDH) in babies. Studies have shown that the Pavlik harness effectively treats DDH by keeping the hips in the correct position, aiding proper development. Research indicates that starting treatment with the Pavlik harness early, particularly in the first few months of life, can lead to good results. Some studies suggest that the duration and timing of harness use are crucial for its success. Although no universal duration exists for its use, evidence supports its effectiveness in managing DDH when used correctly. Participants in this trial will be assigned to either a 12-week or a 6-week Pavlik harness treatment arm to evaluate the optimal duration for treatment success. ^{1 2 6 7 8}

Who Is on the Research Team?

Gaia Georgopoulos, MD

Principal Investigator

Children's Hospital Colorado

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• 12 week standard of care
• Duration of Pavlik Harness treatment

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 231 infants with grade I developmental dysplasia of the hip treated with a Pavlik harness, 58.4% achieved successful outcomes, defined as an acetabular index of less than 30°.

Younger age, lower initial acetabular index, and unilateral dysplasia were significant predictors of success, with specific thresholds identified for unsuccessful treatment: age 4.5 months or older and an acetabular index of 35.5° or higher.

NCBI (Pubmed)

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. Yasin, MS., Al Karmi, J., Suleiman, DO., et al.[2023]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6090187/

Treatment of developmental dysplasia of the hip with the ... There are few published data comparing the efficacy of the Pavlik harness with other abduction braces. The Von Rosen splint was considered to have a better ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0976566225000402

Review article Impact of age and timing of hip orthosis on ... Ultrasound features predicting the 3-week outcome of Pavlik harness treatment for developmental hip dysplasia. Ann Palliat Med, 9 (3) (2020), pp. 1020-1029 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07111858

Study Details | NCT07111858 | Pavlik Harness Treatment ... Developmental Dysplasia of the Hip (DDH) is thoroughly manageable if treated correctly. While the standard treatment is using a Pavlik harness, ...

4. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2022.1018641/full

The nomogram predicting the early failure rate of the Pavlik ... The aim of our study was to develop a nomogram predicting the early failure rate of Pavlik harness in infants under 6 months of age with developmental ...

5. jmatonline.com jmatonline.com/PDF/53-58-PB-98-1.pdf

Effectiveness of Mom-Made Pavlik Harness for Maintaining ... The Pavlik harness is known to be an effective method of treatment of developmental dysplasia of the hip (DDH) in infants(1,2). Extension and adduction of the ...

6. nature.com nature.com/articles/s41598-020-66634-1

Abduction treatment in stable hip dysplasia does not alter ... The most commonly used abduction brace is the Pavlik harness. The ... Pavlik harness were noted in the medical records as safety outcome.

7. bmcpediatr.biomedcentral.com bmcpediatr.biomedcentral.com/articles/10.1186/s12887-023-03935-0

Known risk factors of the developmental dysplasia of the hip ... Our results suggest that positive family history and girl sex could be risk factors for failure of the Pavlik harness treatment. Still, ...

8. journals.sagepub.com journals.sagepub.com/doi/10.1177/18632521231217330

Effect of the Pavlik harness used in the treatment ... Our study indicates that Pavlik harness treatment for developmental dysplasia of the hip is generally safe and does not lead to clinically significant delays.