Observation vs. Bracing for Hip Dysplasia

Overseen By Bryn Zomar, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Older than 3 months, Hip instability, Neuromuscular abnormalities, Prior treatment, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

514 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether monitoring babies with mild hip dysplasia (a condition where the hip joint doesn't form properly) can be as effective as using a Pavlik harness brace, commonly used to treat this condition. The researchers aim to determine if some babies can naturally improve without bracing, potentially avoiding the challenges and bonding disruption associated with wearing the brace. Babies under three months old, whose hips show signs of mild dysplasia but remain stable, might be suitable for this study. By comparing these two approaches across different countries, the trial seeks to identify the best way to support children and families worldwide. As an unphased trial, it offers families the chance to contribute to research that could enhance care for babies with hip dysplasia globally.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Pavlik harness is generally safe for treating developmental dysplasia of the hip (DDH) in babies. Studies have found that this harness does not significantly delay a child's development. It gently holds a baby's hips in the correct position, aiding proper hip joint growth. This treatment often succeeds when started early. Overall, the Pavlik harness is well-tolerated by babies and serves as a common non-surgical option for DDH. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different approaches to managing hip dysplasia in infants—observation versus bracing with a Pavlik harness. Traditionally, hip dysplasia is often treated using various braces or surgical interventions. The Pavlik harness is unique because it gently positions the baby's hips properly without invasive procedures, potentially reducing the need for surgery. By comparing active monitoring (observation) against the use of a Pavlik harness, researchers aim to determine if non-invasive monitoring can be just as effective as bracing, thereby simplifying treatment and minimizing discomfort for infants. This trial could provide insights into more flexible and less intrusive treatment options for hip dysplasia.

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

Research shows that the Pavlik harness can help treat developmental dysplasia of the hip (DDH) in babies. This harness keeps the baby's hips in the correct position, allowing proper growth. Studies have found it works best when used early, especially in babies with moderate DDH. However, delayed treatment may reduce its effectiveness. In this trial, some babies will receive the Pavlik harness as part of the brace treatment group. Others will join the active monitoring group, where researchers will carefully observe to determine if monitoring can be as effective as using the harness for babies with mild DDH. ^{5 6 7 8 9}

Who Is on the Research Team?

Kishore Mulpuri, FRCSC

Principal Investigator

University of British Columbia

Emily Schaeffer, PhD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for babies under three months old with mild Developmental Dysplasia of the Hip (DDH), which means their hip joints are not formed properly. They must have a specific range of hip angles and coverage on ultrasound exams. Babies with more severe DDH or other health issues that could interfere with the study are not eligible.

Inclusion Criteria

Radiological dysplasia defined as a centred hip with an alpha angle between 43 and 60 degrees and a percent coverage of the femoral head (FHC) greater than 35%, as measured on ultrasound exam

My baby has hip issues detected on an X-ray but is under 3 months old.

Exclusion Criteria

Patients presenting with radiological dysplasia older than three months (12 weeks) of age

Patients presenting with clinical hip instability (Ortolani or Barlow positive)

I have been treated for hip dysplasia before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either brace treatment with a Pavlik harness for a minimum of six weeks or active monitoring without intervention

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of acetabular index and other hip measurements

2 years

Regular visits at 6 weeks, 6 months, 1 year, 18 months, and 2 years

Long-term Follow-up

Participants may continue to be monitored for additional outcomes related to hip development and quality of life

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Pavlik Harness

Trial Overview The study is testing if careful observation is as effective as using a Pavlik Harness, which is a brace used to treat babies with DDH. The comparison will help determine if bracing can be avoided in cases of mild DDH without affecting outcomes.

How Is the Trial Designed?

Group I: Brace Treatment Experimental Treatment 1 Intervention

Patients randomized to the brace treatment group will be treated with a Pavlik harness for a minimum of six weeks.

Group II: Active Monitoring Active Control 1 Intervention

Patients randomized to the control group will undergo observation only.

Pavlik Harness is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Pavlik Harness for:

• Developmental dysplasia of the hip (DDH)
• Femur fractures in infants

Approved in United States as Pavlik Harness for:

• Developmental dysplasia of the hip (DDH)
• Femur fractures in infants

Approved in Canada as Pavlik Harness for:

• Developmental dysplasia of the hip (DDH)
• Femur fractures in infants

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Published Research Related to This Trial

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]

Hip dysplasia in newborns is diagnosed through physical examination, while x-rays are useful for confirming the diagnosis in older infants.

The Pavlik harness is a recommended treatment for hip dysplasia, noted for its safety and effectiveness, and treatment should start immediately upon suspicion of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hip dysplasia in infancy. Diagnosis and treatment. Hirsch, PJ., Hirsch, SA., Reedman, L.[2004]

In a study comparing treatments for developmental dysplasia of the hip (DDH), the Frejka splint showed a failure of reduction rate of 10%, while the Pavlik harness had a slightly higher rate of 12%, indicating comparable efficacy between the two methods.

The incidence of avascular necrosis (AVN) was similar for both treatments, with 7% in the Frejka splint group and 6% in the Pavlik harness group, suggesting that the Frejka splint may be as safe as the Pavlik harness when used correctly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pavlik harness versus Frejka splint in treatment of developmental dysplasia of the hip: bicenter study. Atar, D., Lehman, WB., Tenenbaum, Y., et al.[2022]

The study involving 55 caregiver-child dyads found that treatment with the Pavlik harness for developmental dysplasia of the hip did not significantly affect parental bonding or family functioning over a 6-week period, with scores improving steadily throughout treatment.

Despite some impact on family life, the effects of Pavlik harness treatment were less severe than those experienced by families of school-age children with chronic medical conditions, providing reassurance for clinicians when counseling families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Are the Psychosocial Effects of Pavlik Harness Treatment? A Prospective Study on Perceived Impact on Families and Maternal-Infant Bonding. Batley, MG., Gornitzky, AL., Sarkar, S., et al.[2023]

The study analyzed 53 infants with dislocated hips treated with the Pavlik harness (PH) and found that longer brace treatment (8.9 months) did not lead to better acetabular development compared to shorter treatment (2.6 months) at the 2-year follow-up.

Both treatment protocols had similar success rates in achieving hip reduction (88% for longer treatment vs. 85% for shorter treatment), indicating that prolonged use of the PH may not be necessary for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prolonged Brace Treatment Does Not Result in Improved Acetabular Indices in Infantile Dislocated Hips. Upasani, VV., Bomar, JD., Fitzgerald, RE., et al.[2022]

The Pavlik harness has been a standard treatment for developmental dysplasia of the hip for nearly 60 years, but it is less effective for unstable hips with significant acetabular dysplasia.

The authors introduced a simple modification to the Pavlik harness that successfully stabilized three previously unstable hips, suggesting potential improvements in treatment efficacy for challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A simple modification of the Pavlik harness for unstable hips. Maclean, JG., Hawkins, A., Campbell, D., et al.[2019]

The Pavlik harness is highly effective for treating congenital hip dislocation and dysplasia, achieving success in 99% of cases.

The treatment was associated with minimal complications, indicating a high safety profile for this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of congenital hip dislocation and dysplasia with the Pavlik harness. Johnson, AH., Aadalen, RJ., Eilers, VE., et al.[2022]

The Pavlik harness is an effective treatment for developmental dysplasia of the hip (DDH), achieving an 81.9% reduction rate in a study of 221 hips over at least one year.

Key predictors for treatment failure include the distance 'a' and the presence of an adduction contracture, with a distance 'a' of less than 6 mm being a strong indicator of potential failure and risk for avascular necrosis (AVN).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive factors for unsuccessful treatment of developmental dysplasia of the hip by the Pavlik harness. Kitoh, H., Kawasumi, M., Ishiguro, N.[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]

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 ... However, the effectiveness of the Pavlik harness diminishes with delayed treatment, particularly in severe cases (Graf type-III or IV), where the risk of ...

3. childrenscolorado.org childrenscolorado.org/advances-answers/recent-articles/Pavlik-harness-duration/

Reconsidering Pavlik Harness Duration for Hip Dysplasia Infants with moderately severe developmental hip dysplasia may not require a full 12 weeks of Pavlik harnessing to achieve normalization.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05869851

Developmental Dysplasia of the Hip: Observation Vs. Bracing The Pavlik harness is an abduction brace used for treatment of hip dysplasia in infants. It keeps the hips in proper alignment to allow for appropriate growth ...

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12313359/

The impact of brace treatment for developmental dysplasia ... Brace treatment, commonly involving devices such as the Pavlik harness, is the standard non-surgical intervention for DDH in infants. Although ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10859113/

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.

8. hipdysplasia.org hipdysplasia.org/infant-child/child-treatment-methods/pavlik-harness/

Infant & Child - Pavlik Harness The Pavlik harness is specially designed to gently position your baby's hips so they are aligned in the joint, and to keep the hip joint secure.

9. 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 outcome of this treatment is widely considered successful if started at a ...