Spica Casts for Hip Dysplasia

Overseen By Ally Yang, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Over 18 months, Open surgery, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different treatments for developmental dysplasia of the hip (DDH), a condition where a child's hip joint doesn't develop properly. The study compares two treatments: one group will use a spica cast (a type of immobilization cast) for 12 weeks, while the other will start with a spica cast for 6 weeks and then switch to a hip brace for another 6 weeks. The goal is to determine if combining these methods can lead to better results and an easier experience for families. The trial seeks children between 6–18 months old who have been diagnosed with DDH and require a hip spica cast after a procedure called closed reduction. As an unphased trial, this study offers families the opportunity to contribute to innovative treatment approaches for DDH.

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

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe for treating hip dysplasia?

Research shows that spica casts effectively treat developmental dysplasia of the hip (DDH), often outperforming hip braces alone. The casts provide strong support and stability, crucial for healing. In terms of safety, children commonly use and tolerate spica casts well for hip problems.

Studies report high success rates, between 90.4% and 99.8%, when spica casts are combined with other methods like the Pavlik harness. This makes them a preferred first choice for many doctors treating DDH in infants. Although the cast may sometimes need changing under anesthesia, the treatment is generally considered safe.

Overall, spica casts reliably manage DDH, with a strong history of helping young patients recover well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new approach for treating hip dysplasia with spica casts because it might offer a more comfortable and potentially effective way to manage the condition. Unlike the standard 12-week spica cast treatment, which is the current norm, the experimental method uses a spica cast for only 6 weeks before transitioning to a brace for another 6 weeks. This adjustment could mean less time in a rigid cast, possibly leading to increased mobility and comfort for young patients. Additionally, this method could reduce the need for anesthesia, which is required to change the cast at the 6-week mark in the traditional approach. This new protocol might not only enhance patient comfort but also streamline the treatment process, making it less invasive.

What is the effectiveness track record for spica casts in treating hip dysplasia?

Research has shown that spica casts effectively treat developmental dysplasia of the hip (DDH). Studies have found that spica casts provide excellent stability, especially for patients at higher risk. Success rates with casts, such as the Tübinger splint or Pavlik harness, range from 90.4% to 99.8%, making them a top choice for DDH treatment. In this trial, one group will receive a hip spica cast for 12 weeks, the standard treatment. Another group will receive a hip spica cast for 6 weeks followed by a brace for 6 weeks. Braces can offer similar success with the added benefit of better patient satisfaction and less impact on daily life. The study aims to combine both methods to improve the treatment experience. ^{1 2 6 7 8}

Who Is on the Research Team?

Dominick Tuason, MD

Principal Investigator

Yale University

Adrienne Socci, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for children with developmental dysplasia of the hip (DDH), a condition where the hip joint hasn't formed properly. The study is open to those who haven't yet been treated for DDH. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

Provision of signed and dated informed consent form

I need a procedure to realign my hip and a cast.

My child is between 6 to 18 months old.

Exclusion Criteria

I need surgery to correct misaligned bones due to abnormal growth.

My family and I do not wish to participate in the study.

I was scheduled for a less invasive hip surgery, but it was changed to an open surgery during the operation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a hip spica cast for 6 weeks, followed by a transition to a brace for 6 weeks in the experimental group, or a hip spica cast for 12 weeks in the control group

12 weeks

Regular follow-ups every 2-3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rhino brace
• Spica cast

Trial Overview The study compares two treatments for DDH: a spica cast followed by a Rhino brace, each used for six weeks. It aims to see if combining these methods can improve patient experience while maintaining treatment effectiveness.

How Is the Trial Designed?

Group I: Hip Spica 6 weeks, Brace 6 weeks Experimental Treatment 2 Interventions

The experimental group will be placed in a hip spica cast for a total of 6 weeks, then will transition to a brace for 6 weeks.

Group II: Hip Spica 12 weeks (Control) Active Control 1 Intervention

The control group will be placed in a hip spica cast for a total of 12 weeks with a change of spica cast, under anesthesia, at the 6-week mark. This treatment is the accepted standard of care for children who undergo closed reduction of a developmentally dysplastic and dislocated hip.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11996778/

Long-leg spica casts demonstrate superior outcomes in ... Long-leg spica casting shows superior biomechanical stability in DDH management post-CR, particularly for high-risk patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9318343/

Outcome Prognostic Factors in MRI during Spica Cast ... Success rates of 90.4–99.8% have been shown for the Tübinger splint, the Pavlik harness, or casts, and as such are considered first-line therapy in neonates [6 ...

3. withpower.com withpower.com/trial/phase-hip-dysplasia-2024-ce498

Spica Casts for Hip Dysplasia · Info for Participants Research shows that using a spica cast for treating developmental dysplasia of the hip in children is effective, with 82% of patients having satisfactory ...

4. journals.lww.com journals.lww.com/pedorthopaedics/fulltext/9900/assessing_caregiver_experiences_using_hip_spica.952.aspx

Assessing Caregiver Experiences Using Hip Spica Casts in... Out of 140 respondents, many reported difficulties with daily activities, hygiene, and bonding due to the cast.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06204068

Study Details | NCT06204068 | Spica Cast Duration for DDH While spica casts are shown to very effective in treating DDH, and potentially more effective than hip braces alone, other research shows that the outcomes ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2768276525000860

Hip Spica Cast Application Hip spica casts can be used for immobilization in a nontraumatic setting, such as after a closed or open reduction of a dislocated dysplastic hip or to ...

7. mdpi.com mdpi.com/2227-9067/9/7/1010

Outcome Prognostic Factors in MRI during Spica Cast ... Success rates of 90.4–99.8% have been shown for the Tübinger splint, the Pavlik harness, or casts, and as such are considered first-line therapy in neonates [6, ...

8. jposna.com jposna.com/article/S2768-2765(24)00447-4/fulltext

Closed Reduction of Developmental Dislocation of the Hip ... This paper presents a detailed surgical technique guide to help physicians with closed reduction, casting with waterproof material, and advanced perioperative ...