300 Participants Needed

Spica Casts for Hip Dysplasia

DT
AY
Overseen ByAlly Yang, MD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Yale University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Rhino brace, Spica cast for hip dysplasia?

Research shows that using a spica cast for treating developmental dysplasia of the hip in children is effective, with 82% of patients having satisfactory results. This suggests that the spica cast is a reliable treatment option for hip dysplasia.12345

How does the spica cast treatment for hip dysplasia differ from other treatments?

The spica cast is unique because it immobilizes the hip after surgery, which is crucial for healing in conditions like hip dysplasia. Unlike other treatments that may allow for early mobilization, the spica cast provides stability and support, especially in young children, to ensure proper alignment and healing.24567

What is the purpose of this trial?

This study looks at treatment for developmental dysplasia of the hip (DDH), a condition where there is abnormal development of a child's hip joint. 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 from braces are equivalent to those of spica casts with the added advantage of greater patient satisfaction and less burden on families. Therefore, the 12-week experimental protocol in the study, with the first 6 weeks involving the spica cast and the second 6 weeks the hip brace, was designed to determine if both treatment methods can be combined for an optimal patient experience.

Research Team

AS

Adrienne Socci, MD

Principal Investigator

Yale University

DT

Dominick Tuason, MD

Principal Investigator

Yale University

Eligibility Criteria

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.
See 4 more

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.
See 2 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Hip Spica 6 weeks, Brace 6 weeksExperimental Treatment2 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 Control1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

References

Foam Splint versus Spica Cast-Early Mobilization after Hip Reconstructive Surgery in Children-Preliminary Data from a Prospective Randomized Clinical Trial. [2022]
Reinforcing a spica cast with a fiberglass bar. [2022]
Treatment of developmental dysplasia of the hip before walking: results of closed reduction and immobilization in hip spica cast. [2019]
Results after spica cast immobilization following hip reconstruction in 95 cases: is there a need for alternative techniques? [2022]
Outcome after early mobilization following hip reconstruction in children with developmental hip dysplasia and luxation. [2022]
Treatment of congenital dislocation of the hip. Results of closed reduction and immobilization in the hip spica cast. [2004]
Single-Leg Spica Cast Application for Treatment of Pediatric Femoral Fracture. [2020]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security