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

Trial Summary

Will I have to stop taking my current medications?

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

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

The Pavlik harness is a widely used and successful treatment for developmental dysplasia of the hip, with a study showing a 99% success rate in treating congenital hip dislocation and dysplasia without significant complications. ^{1 2 3 4 5}

Is the Pavlik harness safe for treating hip dysplasia in infants?

The Pavlik harness is generally safe for treating hip dysplasia in infants, but there is a risk of avascular necrosis (AVN), which is a condition where bone tissue dies due to lack of blood supply. This risk highlights the importance of proper application and monitoring during treatment. ^{1 3 4 6 7}

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

The Pavlik harness is a unique treatment for hip dysplasia in infants because it is a soft brace that allows for movement while gently holding the hip in the correct position, unlike other rigid splints. It is the most common initial treatment worldwide and requires parents to learn how to apply it at home, which is crucial for its success. ^{1 4 7 8 9}

What is the purpose of this trial?

Developmental dysplasia of the hip (DDH) is the most common childhood hip condition. When caught early, bracing is the most frequently used treatment; however, the brace can disrupt important mother-baby bonding time in the newborn period and present challenges to daily living. In babies with mild DDH, some studies have suggested that their hips may improve naturally as they grow and develop. This study will look at whether careful monitoring can be just as good as bracing for babies diagnosed with mild DDH less than 3 months of age, potentially avoiding unnecessary treatment. This will be the first study to look at this question with babies being treated at different hospitals in seven different countries, so the results will make an impact on children and families worldwide.

Research Team

Kishore Mulpuri, FRCSC

Principal Investigator

University of British Columbia

Emily Schaeffer, PhD

Principal Investigator

University of British Columbia

Eligibility Criteria

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 a known muscle, collagen, genetic disorder, or hip abnormality.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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]

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]

References

1. 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]

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

A simple modification of the Pavlik harness for unstable hips. [2019]

4. United States 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. [2023]

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

Treatment of congenital hip dislocation and dysplasia with the Pavlik harness. [2022]

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

Predictive factors for unsuccessful treatment of developmental dysplasia of the hip by the Pavlik harness. [2022]

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

Prolonged Brace Treatment Does Not Result in Improved Acetabular Indices in Infantile Dislocated Hips. [2022]

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

Hip dysplasia in infancy. Diagnosis and treatment. [2004]

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

Pavlik harness versus Frejka splint in treatment of developmental dysplasia of the hip: bicenter study. [2022]