Dysplasia; HipNCT06204068
Spica Cast Duration for DDH
A study testing Spica cast and Rhino brace in people with Dysplasia; Hip, run by Yale University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 0 to 18 months
- Conditions the study is for
- Dysplasia; Hip
- What is being tested?
- Spica cast and Rhino brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Diagnosed with DDH
- Require closed reduction of the hip and hip spica casting
- between 6-18 months old
- Alpha angle <60 degrees, beta angle >55 degrees
Show all 9Show fewer
- Alpha angle is an angle created by lines along bony acetabulum and the ilium, normal is >60 degrees
- 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
Who cannot join
- Patients over the age of 18 months
- Patients with DDH who do not require closed reduction surgery
- Patients with DDH who are initially consented for closed reduction surgery but their intraoperative findings necessitate conversion to open surgery
- Families that do not want to participate in the study
- Patients with dysplasia that need open reduction
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06520
About this study
Official title: A Prospective Analysis of Optimal Spica Cast Duration Following Closed Reduction for Developmental Dysplasia of the Hip (DDH)
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.
Read the detailed description
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.
- Conditions
- Dysplasia; Hip
- Being tested
- Spica cast, Rhino brace
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spica castDevice
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.
Rhino braceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Hip Spica 6 weeks, Brace 6 weeks | Experimental | 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. Receives: Device: Spica cast; Device: Rhino brace |
| Hip Spica 12 weeks (Control) | Active comparator | 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. Receives: Device: Spica cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks and 12 weeks
Complications Rate
The incidence of any complications that occur over the 12 week course.
Measured: up to 12 weeks
Hospital Re-Admission Rate
Number of participants re-admitted to the hospital
Measured: up to 12 weeks
Mean Time to Hospital Re-Admission
Mean Time to Hospital Re-Admission in days
Measured: up to 12 weeks
Secondary outcomes (1)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study startMay 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Why it stopped: Lack of enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysplasia; HipStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominick Tuason, MD, Principal investigator, Yale UniversityAdrienne Socci, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204068
- Sponsor's protocol ID
- 2000035569
- Other IDs
- 000
- Status last verified
- Jul 2025
- First submitted
- 2 Jan 2024
- Last updated
- 24 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Analysis of Optimal Spica Cast Duration Following Closed Reduction for Developmental Dysplasia of the Hip (DDH)
- ClinicalTrials.gov ID
- NCT06204068
- Acronym / sponsor ID
- 2000035569
- Conditions
- Dysplasia; Hip
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrolment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hip Spica 6 weeks, Brace 6 weeks | Experimental | Device: Spica cast, Device: Rhino braceThe 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. |
| Hip Spica 12 weeks (Control) | Active comparator | Device: Spica castThe 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 may qualify
- Ages
- 0 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Diagnosed with DDH
- Require closed reduction of the hip and hip spica casting
- Beta angle is an angle created by lines along the labrum and ilium, normal is <55 degrees
Key exclusion criteria (5 listed)
- Patients over the age of 18 months
- Patients with DDH who do not require closed reduction surgery
- Patients with DDH who are initially consented for closed reduction surgery but their intraoperative findings necessitate conversion to open surgery
- Families that do not want to participate in the study
- Patients with dysplasia that need open reduction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spica castSpica 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. | Device | Hip Spica 12 weeks (Control), Hip Spica 6 weeks, Brace 6 weeks |
| Rhino braceHip 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. | Device | Hip Spica 6 weeks, Brace 6 weeks |
Primary outcome
Re-Dislocation Rate
Time frame: up to 12 weeks
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.
Patient Satisfaction Scores using Pediatric Outcome Questionnaire
Time frame: 6 weeks and 12 weeks
Pediatric Outcome Questionnaire - 86 questions, item scores are summed for a total score. Total score range from 0-100, Higher score means higher satisfaction.
Complications Rate
Time frame: up to 12 weeks
The incidence of any complications that occur over the 12 week course.
Hospital Re-Admission Rate
Time frame: up to 12 weeks
Number of participants re-admitted to the hospital
Mean Time to Hospital Re-Admission
Time frame: up to 12 weeks
Mean Time to Hospital Re-Admission in days
1 secondary outcome
Family Satisfaction/Burden using Pediatric Outcome Questionnaire
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominick Tuason, MD principal investigator
Yale University
Adrienne Socci, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spica cast and Rhino brace in people with Dysplasia; Hip, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-Dislocation Rate (time frame: up to 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.