An interventional study of Spica cast and Rhino brace in Dysplasia; Hip, sponsored by Yale University. Withdrawn at 1 site in United States. Open to participants aged 0 Months to 18 Months. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
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.
The primary objective of this study is to compare the clinical outcomes of patients who undergo closed reduction of a developmentally dysplastic hip and are treated with six weeks of supplemental casting to those treated with twelve weeks of supplemental casting.
The secondary objectives of this study are to determine if a shorter duration of postoperative casting affects family satisfaction and costs compared to the traditional pathway (12 weeks of spica casting).
The physician will meet with the patients during the regular standard of care follow-ups every 2-3 weeks to track patient progress. Following 6 weeks of recovery, the control group will have their spica cast replaced in the operating room, with the child anesthetized, by another cast for 6 weeks. The experimental group will have their cast removed in the clinic without anesthesia and will be placed into a full-time brace for 6 weeks. Participants will be instructed to complete the full 12 weeks of the protocols. Only patients who complete the full length of treatment in either group will be considered for the study. The physicians will keep track of patients during visits to ensure the protocols are being followed.
107 studies on the registry are indexed under Hip Dislocation; 36 are open to participants now.
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Require closed reduction of the hip and hip spica casting
i. Alpha angle is an angle created by lines along bony acetabulum and the ilium, normal is >60 degrees
ii. Beta angle is an angle created by lines along the labrum and ilium, normal is \<55 degrees
c.Have either failed Pavlik harness or have dislocated hip on imaging
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Spica cast · Device: Rhino brace
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.
Device: Spica cast
Spica cast is a cast that is placed while the child is sedated or under anesthesia, covering lower part of belly, waist, and both legs made up of fiberglass, also keeps legs in abduction and flexion. This device will be used as intended and is commonly used for the treatment of DDH.
Hip abduction brace will be used, which keeps the legs abducted and flexed. A hip brace is a special type of brace that is designed to hold the hips in a flexed and abducted position. This position allows the hip joint to develop properly while it heals. This device will be used as intended and is commonly used for the treatment of DDH.
Re-Dislocation Rate
The incidence of DDH re-occurrence in patients over the 12 week course of the casting or bracing for early re-dislocation rate. This will be the main quantitative value that directly measures the effectiveness of the protocols on maintaining the results of the closed reduction surgery.
Time frame: up to 12 weeks
Patient Satisfaction Scores using Pediatric Outcome Questionnaire
Pediatric Outcome Questionnaire - 86 questions, item scores are summed for a total score. Total score range from 0-100, Higher score means higher satisfaction.
Time frame: 6 weeks and 12 weeks
Complications Rate
The incidence of any complications that occur over the 12 week course.
Time frame: up to 12 weeks
Hospital Re-Admission Rate
Number of participants re-admitted to the hospital
Time frame: up to 12 weeks
Mean Time to Hospital Re-Admission
Mean Time to Hospital Re-Admission in days
Time frame: up to 12 weeks
Family Satisfaction/Burden using Pediatric Outcome Questionnaire
Pediatric Outcome Questionnaire - 86 questions, item scores are summed for a total score. Total score range from 0-100, Higher score means higher satisfaction.
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2025; primary completion for Jan 2026, 8 months later.
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This study is withdrawn, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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